A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease (Open PRIDE-HD)

Prilenia

Status and phase: Terminated; Phase 2

Conditions: Huntington's Disease

Treatments: Drug: Pridopidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02494778

2015-000904-24 (EudraCT Number)

TV7820-CNS-20016

Details and patient eligibility

About

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).

Enrollment: 248 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

248 participants in 1 patient group

Pridopidine

Experimental group

Description:

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.

Treatment:

Drug: Pridopidine