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PRidopidine's Outcome On Function in Huntington Disease, PROOF- HD

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ClinicalTrials.gov Identifier: NCT04556656
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Prilenia

Tracking Information
First Submitted Date  ICMJE September 14, 2020
First Posted Date  ICMJE September 21, 2020
Last Update Posted Date January 29, 2021
Actual Study Start Date  ICMJE October 16, 2020
Estimated Primary Completion Date March 3, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2020)		 Change from baseline in the Unified Huntington Disease Rating Scale-Total functional capacity (UHDRS-TFC) score [ Time Frame: Baseline, 65 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PRidopidine's Outcome On Function in Huntington Disease, PROOF- HD
Official Title  ICMJE 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
Brief Summary This study will evaluate the efficacy and safety of pridopidine 45mg twice daily (BID) in patients with early stage manifest Huntington Disease (HD).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Huntington Disease
Intervention  ICMJE
  • Drug: Pridopidine
    Pridopidine hard gelatin capsule
  • Drug: Placebo
    Pridopidine-matching placebo hard gelatin capsule
Study Arms  ICMJE
  • Experimental: Pridopidine
    45 mg pridopidine twice daily (BID)
    Intervention: Drug: Pridopidine
  • Placebo Comparator: Placebo
    Matching placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2020)		 480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 7, 2023
Estimated Primary Completion Date March 3, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kristin Strazdins 1-585-242-0967 Kristin@hsglimited.org
Listed Location Countries  ICMJE Germany,   Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04556656
Other Study ID Numbers  ICMJE PL101-HD301
2020-002822-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prilenia
Study Sponsor  ICMJE Prilenia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Prilenia
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP