Clinical Trial Results:
Peripheral neuropathy as potential side effect in patients with multiple sclerosis treated with teriflunomide.
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Summary
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EudraCT number |
2021-002810-15 |
Trial protocol |
BE |
Global end of trial date |
20 Jan 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Apr 2022
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First version publication date |
25 Apr 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CHUB-Neuro-ENMG-MS
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
CHU Brugmann
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Sponsor organisation address |
4 Place A. Van Gehuchten , Brussels, Belgium, 1020
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Public contact |
Neurology Department, CHU Brugmann, 32 24772446, Bernard.DACHY@chu-brugmann.be
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Scientific contact |
Neurology Department, CHU Brugmann, 32 24772446, Bernard.DACHY@chu-brugmann.be
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
04 Mar 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Jan 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Jan 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To explore the incidence of peripheral nerve abnormalities, investigated by Nerve Conduction Study, in patients with multiple sclerosis treated with teriflunomide.
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Protection of trial subjects |
Aubagio (teriflunomide) is used as standard of care medication in the CHU Brugmann Hospital for patients with a diagnosis of multiple sclerosis (MS).
Nerve conduction studies are routinely performed in the Neurology Departement and do not put the patients at risk.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 Jul 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 12
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Worldwide total number of subjects |
12
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EEA total number of subjects |
12
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
11
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients were included in the CHU Brugmann Hospital (Brussels, Belgium) only. Patients with previous diagnosis of multiple sclerosis and currently treated with teriflunomide as standard of care were retrospectively identified and prospectively screened for peripheral nerve abnormalities by Nerve Conduction Studies. | ||||||
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Pre-assignment
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Screening details |
20 patients were identified in specialized consultations in multiple sclerosis of CHU Brugmann Hospital. 12 patients signed the informed consent. They all completed all the examinations of the Nerve Conduction Stimulation Testing. | ||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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Teriflunomide | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Teriflunomide
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Investigational medicinal product code |
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Other name |
Aubagio 14 mg
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Pharmaceutical forms |
Coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Aubagio 14mg (coated tablet) once per day, oral use
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Teriflunomide
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Reporting group description |
- | ||
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End point title |
Mean DL, right median nerve, motor response [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean distal amplitude , right median nerve, motor response [2] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean proximal amplitude, right median nerve, motor response [3] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean NCV, right median nerve, motor response [4] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean F-wave latency, right median nerve, motor response [5] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean DL, left median nerve, motor response [6] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean distal amplitude, left median nerve, motor response [7] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean proximal amplitude, left median nerve, motor response [8] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean NCV, left median nerve, motor response [9] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean F-wave latency, left median nerve, motor response [10] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean DL, right ulnar nerve, motor response [11] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean distal amplitude, right ulnar nerve, motor response [12] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean proximal amplitude, right ulnar nerve, motor response [13] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean NCV, right ulnar nerve, motor response [14] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean F-wave latency, right ulnar nerve, motor response [15] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean DL, left ulnar nerve, motor nerve [16] | ||||||||
End point description |
|||||||||
End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean distal amplitude, left ulnar nerve, motor response [17] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean proximal amplitude, left ulnar nerve, motor response [18] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean NCV, left ulnar nerve, motor response [19] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean F-wave latency, left ulnar nerve, motor response [20] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean DL, right peroneal nerve, motor response [21] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean distal amplitude, right peroneal nerve, motor response [22] | ||||||||
End point description |
|||||||||
End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean proximal amplitude, right peroneal nerve, motor response [23] | ||||||||
End point description |
|||||||||
End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean NCV, right peroneal nerve, motor response [24] | ||||||||
End point description |
|||||||||
End point type |
Primary
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End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
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| Notes [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean F-wave latency, right peroneal nerve, motor response [25] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean DL, Left peroneal nerve, motor response [26] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
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|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean distal amplitude, left peroneal nerve, motor response [27] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean proximal amplitude, left peroneal nerve, motor response [28] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
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|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean NCV, left peroneal nerve, motor response [29] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean F-wave latency, left peroneal nerve, motor response [30] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL, right tibial nerve, motor response [31] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean distal amplitude, right tibial nerve, motor response [32] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean proximal amplitude, right tibial nerve, motor response [33] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean NCV, right tibial nerve, motor response [34] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean F-wave latency, right tibial nerve, motor response [35] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL, left tibial nerve, motor response [36] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean distal amplitude, left tibial nerve, motor response [37] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean NCV, left tibial nerve, motor response [38] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean F-wave latency, left tibial nerve, motor response [39] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL onset, right median nerve, sensory response [40] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL Peak, right median nerve, sensory response [41] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean amplitude, right median nerve, sensory response [42] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [42] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean NCV, right median nerve, sensory response [43] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL onset, left median nerve, sensory response [44] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [44] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL peak, left median nerve, sensory response [45] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean amplitude, left median nerve, sensory response [46] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean NCV, left median nerve, sensory response [47] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL onset, right ulnar nerve, sensory response [48] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [48] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL peak, right ulnar nerve, sensory response [49] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean amplitude, right ulnar nerve, sensory response [50] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [50] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean NCV, right ulnar nerve, sensory response [51] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL onset, left ulnar nerve, sensory response [52] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [52] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL peak, left ulnar nerve, sensory response [53] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [53] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean amplitude, left ulnar nerve, sensory response [54] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [54] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean NCV, left ulnar nerve, sensory response [55] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [55] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL onset, right radial nerve, sensory response [56] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [56] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL peak, right radial nerve, sensory response [57] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [57] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean amplitude, right radial nerve, sensory response [58] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [58] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean NCV, right radial nerve, sensory response [59] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [59] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL onset, left radial nerve, sensory response [60] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [60] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL peak, left radial nerve, sensory response [61] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [61] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean amplitude, left radial nerve, sensory response [62] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [62] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean NCV, left radial nerve, sensory response [63] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [63] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL peak, right sural nerve, sensory response [64] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [64] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean amplitude, right sural nerve, sensory response [65] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [65] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean NCV, right sural nerve, sensory response [66] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [66] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL onset, left sural nerve, sensory response [67] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [67] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL peak, left sural nerve, sensory response [68] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [68] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean amplitude, left sural nerve, sensory response [69] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [69] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean NCV, left sural nerve, sensory response [70] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [70] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean proximal amplitude, left tibial nerve, motor response [71] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [71] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean DL onset, right sural nerve, sensory response [72] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Nerve conduction study performed only once, timepoint depending on the delays to obtain an appointment for this examination.
|
||||||||
| Notes [72] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a monocentric, open-label, non-controlled, not randomized, phase IV study. There is only one study arm. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||
|
Adverse events information [1]
|
|||||||||||
Timeframe for reporting adverse events |
Entire trial
|
||||||||||
Assessment type |
Systematic | ||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||
Dictionary name |
Current nomenclature | ||||||||||
Dictionary version |
2022
|
||||||||||
|
Reporting groups
|
|||||||||||
Reporting group title |
Teriflunomide
|
||||||||||
Reporting group description |
- | ||||||||||
|
|||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
|
|||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: There were no non-serious adverse events reported by the principal investigator. The IMP used in this trial (teriflunomide) has a marketing authorization and is indicated for patients with multiple sclerosis. Inclusion criteria restricted the trial population to patients already taking teriflunomide as standard of care medication for their multiple sclerosis. The trial interventions were limited to the screening (once only) for peripheral nerve abnormalities by Nerve Conduction Studies. |
|||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
