Clinical Trial Results:
A Phase III, Multicenter, Double Blind, Randomised, Placebo Controlled Study to Assess the Efficacy and the Safety of a Single Cycle of Dysport Solution in the Treatment of Upper Limb Spasticity in Adult Subjects with Spastic Hemiparesis due to Stroke
Summary
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EudraCT number |
2015-000554-38 |
Trial protocol |
BE CZ SK IT |
Global end of trial date |
16 Jun 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Jul 2020
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First version publication date |
24 Jul 2020
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Other versions |
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Summary report(s) |
Notice of Study Withdrawal |
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 |
D-FR-52120-221
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Ipsen
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Sponsor organisation address |
5 Avenue du Canada, Les Ulis, France, 91940
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Public contact |
Medical Director, Ipsen Innovation, clinical.trials@ipsen.com
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Scientific contact |
Medical Director, Ipsen Innovation, clinical.trials@ipsen.com
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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 |
16 Jun 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Jun 2017
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To assess the efficacy of Dysport Solution 1000 Units (U) compared to placebo in reducing the upper limb muscle tone (using the Modified Ashworth Scale [MAS]) in adult subjects with upper limb spastic hemiparesis due to stroke after one treatment cycle.
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Protection of trial subjects |
Not applicable
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
16 Jun 2017
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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 |
Czech Republic: 99999
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Worldwide total number of subjects |
99999
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EEA total number of subjects |
99999
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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) |
99999
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
99999 is "not applicable" value or 0 participants. This trial was cancelled with no participants enrolled. | ||||||
Pre-assignment
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Screening details |
Not applicable | ||||||
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 | ||||||
Arms
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Arm title
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Dysport | ||||||
Arm description |
Dysport Solution 1000 U | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Dysport
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Investigational medicinal product code |
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Other name |
AbobotulinumtoxinA
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Dose would have been 1000 U by intramuscular injection on Day 1.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
99999 is "not applicable" value or 0 participants. This trial was cancelled with no participants enrolled. | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Dysport
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Reporting group description |
Dysport Solution 1000 U |
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End point title |
Proportion of Subjects by MAS Category in the Primary Targeted Muscle Group at Week 4 [1] | ||||||||
End point description |
99999 is "not applicable" value or 0 participants. This trial was cancelled with no participants enrolled.
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End point type |
Primary
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End point timeframe |
Not applicable
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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: No participants were enrolled in the trial hence results are not available. |
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Notes [2] - No participants were enrolled in the trial hence results are not available. |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
All adverse events occurring during the course of the clinical trial were to be collected.
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
Dysport
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Reporting group description |
Dysport Solution 1000 U | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
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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: No participants were enrolled in the trial hence results are not available. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
99999 is "not applicable" value or 0 participants. The sponsor made the decision to cancel the trial before it was started. Zero participants were enrolled. |