Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson Disease | Drug: Pridopidine Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Double-Blind, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine Versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (gLIDe) |
Actual Study Start Date : | March 26, 2019 |
Actual Primary Completion Date : | July 22, 2020 |
Actual Study Completion Date : | July 22, 2020 |
Arm | Intervention/treatment |
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Experimental: Pridopidine Dose 1
Dose 1 (oral capsule) for 12 weeks following 4 week dosage regimen titration period
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Drug: Pridopidine
Oral capsule
Drug: Placebo Oral capsule
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Experimental: Pridopidine Dose 2
Dose 2 for (oral capsule) for 12 weeks following 4 week dosage regimen titration period
|
Drug: Pridopidine
Oral capsule
|
Placebo Comparator: Placebo
Matching placebo (oral capsule) for 16 weeks
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Drug: Placebo
Oral capsule
|
Ages Eligible for Study: | 30 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria could apply.
Study Director: | Yael Cohen | Prilenia |
Tracking Information | |||||
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First Submitted Date ICMJE | April 17, 2019 | ||||
First Posted Date ICMJE | April 22, 2019 | ||||
Last Update Posted Date | November 9, 2020 | ||||
Actual Study Start Date ICMJE | March 26, 2019 | ||||
Actual Primary Completion Date | July 22, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change in levodopa-induced dyskinesia [ Time Frame: Baseline and Week 16 ] Mean change in the sum of Parts 1, 3 and 4 of the Unified Dyskinesia Rating Scale (UdysRS)
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Original Primary Outcome Measures ICMJE |
Change in levodopa-induced dyskinesia [ Time Frame: Baseline and Week 14 ] Mean change in the sum of Parts 1, 3 and 4 of the Unified Dyskinesia Rating Scale (UdysRS)
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Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease | ||||
Official Title ICMJE | A Double-Blind, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine Versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (gLIDe) | ||||
Brief Summary | This is a multicenter, randomized, three-arm, parallel-group, double-blind, placebo-controlled, study to evaluate the efficacy, safety and pharmacokinetics (PK) of pridopidine vs. placebo for the treatment of Levodopa Induced Dyskinesia (LID) in patients with Parkinson Disease. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Parkinson Disease | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. Review. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
23 | ||||
Original Estimated Enrollment ICMJE |
135 | ||||
Actual Study Completion Date ICMJE | July 22, 2020 | ||||
Actual Primary Completion Date | July 22, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria could apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 30 Years to 85 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03922711 | ||||
Other Study ID Numbers ICMJE | PL101-LID201 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Prilenia | ||||
Study Sponsor ICMJE | Prilenia | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Prilenia | ||||
Verification Date | May 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |