A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease
- Registration Number
- NCT02494778
- Lead Sponsor
- Prilenia
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 248
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pridopidine Pridopidine 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events 106 weeks From signature of the informed consent form through the end of the study, which was defined as Week 106
- Secondary Outcome Measures
Name Time Method Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Onset-interval-SD-Hand Week 52; end of treatment (EOT) which was planned to occur at Week 104 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.
Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Peak-Force-CV-Hand Week 52; end of treatment (EOT) which was planned to occur at Week 104 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.
Trial Locations
- Locations (46)
Teva Investigational Site 12204
🇺🇸Los Angeles, California, United States
Teva Investigational Site 12206
🇺🇸Baltimore, Maryland, United States
Teva Investigational Site 12200
🇺🇸Manhasset, New York, United States
Teva Investigational Site 12203
🇺🇸New York, New York, United States
Teva Investigational Site 12211
🇺🇸Winston-Salem, North Carolina, United States
Teva Investigational Site 78055
🇦🇺Caulfield South, Australia
Teva Investigational Site 12209
🇺🇸Pittsburgh, Pennsylvania, United States
Teva Investigational Site 11036
🇨🇦Toronto, Ontario, Canada
Teva Investigational Site 35122
🇫🇷Creteil, France
Teva Investigational Site 33021
🇦🇹Innsbruck, Austria
Teva Investigational Site 33027
🇦🇹Wien, Austria
Teva Investigational Site 35121
🇫🇷Salouel, France
Teva Investigational Site 35125
🇫🇷Lille Cedex, France
Teva Investigational Site 32410
🇩🇪Bochum, Germany
Teva Investigational Site 30083
🇮🇹Firenze, Italy
Teva Investigational Site 32407
🇩🇪Ulm, Germany
Teva Investigational Site 53149
🇵🇱Krakow, Poland
Teva Investigational Site 38059
🇳🇱Leiden, Netherlands
Teva Investigational Site 53150
🇵🇱Gdansk, Poland
Teva Investigational Site 53148
🇵🇱Poznan, Poland
Teva Investigational Site 53151
🇵🇱Warsaw, Poland
Teva Investigational Site 50215
🇷🇺Kazan, Russian Federation
Teva Investigational Site 34058
🇬🇧Birmingham, United Kingdom
Teva Investigational Site 34061
🇬🇧Newcastle-Upon-Tyne, United Kingdom
Teva Investigational Site 34056
🇬🇧Oxford, United Kingdom
Teva Investigational Site 34057
🇬🇧Sheffield, United Kingdom
Teva Investigational Site 12208
🇺🇸Salt Lake City, Utah, United States
Teva Investigational Site 78058
🇦🇺West Perth, Australia
Teva Investigational Site 78057
🇦🇺Westmead, Australia
Teva Investigational Site 12198
🇺🇸Rochester, New York, United States
Teva Investigational Site 12196
🇺🇸Washington, District of Columbia, United States
Teva Investigational Site 12201
🇺🇸Englewood, Colorado, United States
Teva Investigational Site 12210
🇺🇸Richmond, Virginia, United States
Teva Investigational Site 30080
🇮🇹Milano, Italy
Teva Investigational Site 30082
🇮🇹Napoli, Italy
Teva Investigational Site 32409
🇩🇪Munster, Germany
Teva Investigational Site 30081
🇮🇹San Giovanni Rotondo, Italy
Teva Investigational Site 32408
🇩🇪Berlin, Germany
Teva Investigational Site 50213
🇷🇺Moscow, Russian Federation
Teva Investigational Site 34059
🇬🇧Cardiff, United Kingdom
Teva Investigational Site 34055
🇬🇧Manchester, United Kingdom
Teva Investigational Site 50214
🇷🇺Nyznij Novgorod, Russian Federation
Teva Investigational Site 34054
🇬🇧Cambridge, United Kingdom
Teva Investigational Site 35123
🇫🇷Angers cedex 9, France
Teva Investigational Site 35165
🇫🇷Toulouse, France
Teva Investigational Site 35124
🇫🇷Marseille Cedex 5, France