Clinical Trial Results:
Randomized, double-blind, placebo-controlled crossover study to validate finger tapping tasks for the quantification of levodopa/carbidopa effects in Parkinson’s Disease patients.
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Summary
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EudraCT number |
2020-000686-16 |
Trial protocol |
NL |
Global end of trial date |
05 Nov 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Oct 2022
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First version publication date |
16 Oct 2022
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Other versions |
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Summary report(s) |
Movement Disord Clin Pract - 2022 - Thijssen |
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 |
CHDR1953
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Additional study identifiers
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ISRCTN number |
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US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Centre of Human Drug Research
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Sponsor organisation address |
Zernikedreef 8, Leiden, Netherlands, 2333 CL
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Public contact |
Principal Investigator, Centre for Human Drug Research, +31 715246400, clintrials@chdr.nl
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Scientific contact |
Principal Investigator, Centre for Human Drug Research, +31 715246400, clintrials@chdr.nl
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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 |
25 Jul 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
05 Nov 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Nov 2020
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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 |
Assess whether the finger tapping task endpoints:
• Differentiate between ON and OFF states in PD patients
• Correlate with the golden standard MDS-UPDRS part III total score
• Differentiate between placebo and levodopa/carbidopa treatment
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Protection of trial subjects |
Patients enrolled in this study were already using levodopa or had used it in the past. Therefore, they were expected to tolerate the study treatment well. Nonetheless, subject safety was evaluated by monitoring of adverse events throughout the study, and by examining the patient’s vital signs, ECG and physical/neurological examination before discharge.
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
15 Apr 2020
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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 |
Netherlands: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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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) |
15
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From 65 to 84 years |
5
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85 years and over |
0
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Recruitment
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Recruitment details |
The clinical phase of this study started on July 20, 2020 (screening of first subject) and ended on 05 November, 2020 (last follow-up visit). | |||||||||
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Pre-assignment
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Screening details |
PD patients with self-described motor fluctuations and recognizable OFF periods aged between 20-85 years with Hoehn and Yahr stage I-III were eligible for participation. Patients had to be levodopa responsive as evidenced by current or historical use of levodopa. | |||||||||
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Period 1
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Period 1 title |
Overall trial period (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Assessor | |||||||||
Blinding implementation details |
To ensure blinding, levodopa/carbidopa 100/25 mg (Sinemet) tablets were over-encapsulated in 00 gelatin (Swedish orange) capsules. Similarly, placebo tablets were over-encapsulated.
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Active drugs | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Levodopa/carbidopa
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Levodopa/carbidopa 100/25 mg (Sinemet) tablets. Patients receive a semi-individualized dose, meaning they will be administered 1-5 capsules depending on their own dosing regimen. E.g. if patients only use levodopa as anti-Parkinson medication, they will be administered the number of capsules that most closely matches the dose they usually take. When patients receive other anti-Parkinson medication (as well), a levodopa equivalent dose (LED) of the medication they take in the morning will be calculated. This LED will then indicate the number of capsules that will be administered.
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Arm title
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Placebo | |||||||||
Arm description |
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Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo, over-encapsulated oral tablets similar in appearance as the active drug. The number of capsules is matched to that of the active drug.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial period
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Reporting group description |
- | ||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Active drugs
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Reporting group description |
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Reporting group title |
Placebo
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Reporting group description |
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End point title |
MDS-UPDRS III [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day -1, Day 1 (pre-dose, 10 min, 30 min, 60 min, 90 min, 3,5 hrs)
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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: See attachment. |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From screening until last follow up visit.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21.1
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Reporting groups
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Reporting group title |
Sinemet (Active)
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Reporting group description |
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Reporting group title |
Placebo
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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06 Jul 2020 |
Study start was postponed due to SARS-CoV-2 outbreak. This amendment concerned the updated ICF, advertisement material and protocol conform the CCMO guideline: ‘Conditions (re)start studies in clinical research units, dd 24 june2020’. |
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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. | |||
| None reported | |||
