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

Prilenia46 sites in 11 countries248 target enrollmentSeptember 24, 2015

ConditionsHuntington's Disease

InterventionsPridopidine

DrugsPridopidine

Overview

Phase: Phase 2
Intervention: Pridopidine
Conditions: Huntington's Disease
Sponsor: Prilenia
Enrollment: 248
Locations: 46
Primary Endpoint: Percentage of Participants With Adverse Events
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 24, 2015

End Date

January 12, 2018

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Prilenia

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Pridopidine

Outcomes

Primary Outcomes

Percentage of Participants With Adverse Events

Time Frame: 106 weeks

From signature of the informed consent form through the end of the study, which was defined as Week 106

Secondary Outcomes

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)
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)