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

Phase 2TerminatedNCT02494778

Prilenia248 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

248

Conditions

Huntington's Disease

Interventions

PridopidineDRUG

45 mg BID

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (46)

Outcomes

Primary Outcomes

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

Time frame: 106 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: Week 52; end of treatment (EOT) which was planned to occur at Week 104

Data from ClinicalTrials.gov

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Teva Investigational Site 12204

Los Angeles, California, United States

Teva Investigational Site 12201

Englewood, Colorado, United States

Teva Investigational Site 12196

Washington D.C., District of Columbia, 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 12198

Rochester, New York, United States

Teva Investigational Site 12211

Winston-Salem, North Carolina, United States

Teva Investigational Site 12209

Pittsburgh, Pennsylvania, United States

Teva Investigational Site 12208

Salt Lake City, Utah, United States

...and 36 more locations