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PROOF- HD

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Sponsored by Prilenia

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.

Status
Recruiting

Formal Name
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients With Early Stage of Huntington Disease

Study Type
Interventional (Clinical Trial)

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

Canadian Locations:

Halifax
Location: Prilenia Investigational Site (Site 232)
Halifax, Canada, NS B3S 1L8
Status: Recruiting

Contact: If you are interested in participating at this site, enter NCT 04556656 and Site 232 in subject line of email    800-487-7671    info@hsglimited.org

Ages Eligible for Study: 25 Years and older   (Adult, Older Adult)

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

Inclusion Criteria

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

Exclusion Criteria  (eligibility that would exclude you from this study)

  • Use of pridopidine within 12 months before the baseline visit.
  • Gene therapy at any time
  • 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
  • History of epilepsy or seizures within the last 5 years
  • Pregnant or breastfeeding, or intention to become pregnant during the study

Source 

ClinicalTrials.gov

For more detailed information on this study and others and for the most recent updates, please go to clinicaltrials.gov. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

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