Purpose

This study will evaluate the efficacy and safety of pridopidine 45mg twice daily (BID) in patients with early stage manifest Huntington Disease (HD).

Condition

Eligibility

Eligible Ages
Over 25 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

MAIN STUDY 1. Diagnosis of HD based on clinical features and the presence of ≥36 CAG repeats in the huntingtin gene 2. Diagnostic confidence level (DCL) of 4 3. Adult-onset HD with onset of signs and symptoms ≥18 years of age 4. Stage 1 or Stage 2 HD, defined as a UHDRS-TFC score of ≥7, at screening

Exclusion Criteria

  1. Use of pridopidine within 12 months before the baseline visit. 2. Gene therapy at any time 3. Any serious medical condition or clinically significant laboratory, or vital sign abnormality that precludes the patient's safe participation in and completion of the study e.g. significant heart disease within 12 weeks before baseline or history of certain cardiac arrhythmias 4. History of epilepsy or seizures within the last 5 years 5. Pregnant or breastfeeding, or intention to become pregnant during the study

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pridopidine
45 mg pridopidine twice daily (BID)
  • Drug: Pridopidine
    Pridopidine hard gelatin capsule
Placebo Comparator
Placebo
Matching placebo
  • Drug: Placebo
    Pridopidine-matching placebo hard gelatin capsule

Recruiting Locations

Prilenia Investigational Site (Site 031)
Nashville, Tennessee 37232
Contact:
Danielle Buchanan
615-875-3274
danielle.a.buchanan@vumc.org

More Details

Status
Recruiting
Sponsor
Prilenia

Study Contact

Kristin Strazdins
1-585-242-0967
Kristin@hsglimited.org

Detailed Description

This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pridopidine 45 mg BID in patients with early stage HD. Eligible patients who completed the Main Study (65 to 78 weeks) will have the option to enroll into an open-label extension.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.