A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease

Study Overview
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Brief Summary
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The purpose of the study is to collect and assess long term data on the safety, tolerability, and efficacy of pridopidine in patients with Huntington's disease (HD).

Official Title
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A Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients With Huntington's Disease (Open PRIDE-HD)

Conditions
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Huntington's Disease

Intervention / Treatment
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* Drug: Pridopidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pride HD completion within the last 6 months, including 2 week follow up period or patients who transitioned from the Open HART study or patients who complete future safety and efficacy clinical trials of pridopidine. In addition, patients who have already completed their defined study period under Open PRIDE HD global or local amendments and have discontinued treatment with pridopidine will be allowed to re enter the Open PRIDE HD study. Women of child bearing potential or male participants: Adequate contraception and birth control Good general health other criteria apply, please contact the investigator for more information Exclusion Criteria: Similar baseline criteria for ECG, vital signs, cardiovascular system, and renal function to PRIDE HD; Similar concomitant medication restrictions to PRIDE HD. other criteria apply, please contact the investigator for more information

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pridopidine<br>The mode of administration is oral. Capsules will be swallowed whole with water. One capsule should be taken in the morning and 1 in the afternoon, 7 to 10 hours after the morning dose. Study drug can be taken irrespective of meals. | Drug: Pridopidine<br>* 45 mg BID<br>* Other names: TV7820;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events | From signature of the informed consent form through the end of the study, which was defined as Week 106 | 106 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Onset-interval-SD-Hand | Q-motor assessments were based on the application of force transducers and 3-dimensional position sensors. The reported parameter is the Pro-Sup-Inter-Onset-interval-SD-Hand, measured in seconds. Positive change from baseline indicates worsening. | Week 52; end of treatment (EOT) which was planned to occur at Week 104 | 
| Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Peak-Force-CV-Hand | Q-motor assessments were based on the application of force transducers and 3-dimensional position sensors. The reported parameter is the Pro-Sup-Peak-Force-CV-Hand, measured in %. Positive change from baseline indicates worsening. | Week 52; end of treatment (EOT) which was planned to occur at Week 104 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Huntington's disease, pridopidine