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A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Versus Placebo for Symptomatic Treatment in Patients With Huntington's Disease

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ClinicalTrials.gov Identifier: NCT02006472
Recruitment Status : Completed
First Posted : December 10, 2013
Last Update Posted : March 7, 2019
Sponsor:
Collaborators:
European Huntington's Disease Network
Huntington Study Group
Information provided by (Responsible Party):
Prilenia Therapeutics Development Ltd.

Tracking Information
First Submitted Date  ICMJE December 5, 2013
First Posted Date  ICMJE December 10, 2013
Last Update Posted Date March 7, 2019
Actual Study Start Date  ICMJE February 28, 2014
Actual Primary Completion Date July 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2016)
Change from baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at week 26 [ Time Frame: 26 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
Change from baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at week 26 [ Time Frame: Baseline, Week 26 ]
Change History Complete list of historical versions of study NCT02006472 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2016)
  • Change from Baseline in modified Physical Performance Test (mPPT) [ Time Frame: Baseline and Week 26 ]
    The mPPT quantifies the patient's performance in physical tasks. It is a standardized 9-item test that measures the patient's performance on functional tasks. Patients are given 2 chances to complete each of the 9 items, and assistive devices are permitted for the tasks that require a standing position (items 6 to 9). Both the speed and accuracy at which the patients complete the items are taken into account during scoring. The maximum score of the test is 36, with higher scores indicating better performance.
  • Summary of participants with Adverse Events [ Time Frame: 66 weeks ]
    From signing of Informed Consent Form to the Follow-up Visit (Day 378)
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
  • Change from Baseline in Physical Performance Test (PPT) [ Time Frame: Baseline and Week 26 ]
    The PPT quantifies the patient's performance in physical tasks. It is a standardized 9-item test that measures the patient's performance on functional tasks. Patients are given 2 chances to complete each of the 9 items, and assistive devices are permitted for the tasks that require a standing position (items 6 to 9). Both the speed and accuracy at which the patients complete the items are taken into account during scoring. The maximum score of the test is 36, with higher scores indicating better performance.
  • Summary of participants with Adverse Events [ Time Frame: 30 weeks ]
    From signing of Informed Consent Form to the Follow-up Visit (Day 196)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Versus Placebo for Symptomatic Treatment in Patients With Huntington's Disease
Official Title  ICMJE A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily Versus Placebo for Symptomatic Treatment in Patients With Huntington's Disease
Brief Summary This is a multicenter, multinational, randomized, parallel-group, double-blind, placebo-controlled, dose range finding study to compare the efficacy and safety of different doses of pridopidine versus placebo in the treatment of motor impairment in Huntington's Disease (HD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Huntington's Disease
Intervention  ICMJE
  • Drug: Pridopidine
    22.5 mg and 45 mg capsules
    Other Name: TV7820
  • Other: Placebo
    Capsules matching drug
Study Arms  ICMJE
  • Experimental: Pridopidine 45 mg
    Twice daily
    Interventions:
    • Drug: Pridopidine
    • Other: Placebo
  • Experimental: Pridopidine 67.5 mg
    Twice daily
    Interventions:
    • Drug: Pridopidine
    • Other: Placebo
  • Experimental: Pridopidine 90 mg
    Twice daily
    Interventions:
    • Drug: Pridopidine
    • Other: Placebo
  • Experimental: Pridopidine 112.5 mg
    Twice daily
    Interventions:
    • Drug: Pridopidine
    • Other: Placebo
  • Placebo Comparator: Placebo
    Twice daily
    Intervention: Other: Placebo
Publications * Reilmann R, McGarry A, Grachev ID, Savola JM, Borowsky B, Eyal E, Gross N, Langbehn D, Schubert R, Wickenberg AT, Papapetropoulos S, Hayden M, Squitieri F, Kieburtz K, Landwehrmeyer GB; European Huntington's Disease Network; Huntington Study Group investigators. Safety and efficacy of pridopidine in patients with Huntington's disease (PRIDE-HD): a phase 2, randomised, placebo-controlled, multicentre, dose-ranging study. Lancet Neurol. 2019 Feb;18(2):165-176. doi: 10.1016/S1474-4422(18)30391-0. Epub 2018 Dec 15.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2016)
408
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2013)
400
Actual Study Completion Date  ICMJE August 31, 2016
Actual Primary Completion Date July 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of HD based on the presence of >/= 36 CAG repeats
  • Male or female age ≥21 years, with an onset of HD after 18 years' old.
  • Females of child bearing potential have to be compliant in using adequate birth control throughout the duration of the study
  • Body weight ≥50 kg
  • Sum of >/= 25 points on the UHDRS-TMS and UHDRS Independence Score below 90%
  • Able and willing to provide written informed consent prior to any study related procedure.
  • Willing to provide a blood sample for genetic analyses
  • Willing and able to take oral medication and able to comply with the study specific procedures.
  • Ambulatory, being able to travel to the study centre, and judged by the investigator as likely to be able to continue to travel for the duration of the study.
  • Availability and willingness of a caregiver, informant or family member to accompany the patient to the clinic at study, and the suitability of the caregiver should be judged by the investigator.

    • Other criteria apply, please contact the investigator for more information.

Exclusion Criteria:

  • Patients with clinically significant heart disease at the screening visit
  • Treatment with tetrabenazine within 6 weeks of study screening
  • Patients with a history of epilepsy or of seizures within the last 5 years
  • Have other serious medical illnesses in the opinion of the investigator may put the patient at risk when participating in the study or may influence the results of the study or affect the patient's ability to take part in the study
  • Patients receiving medications (within the last 6 weeks prior to screening) that have been proven to prolong QT interval or who may require such medications during the course of the study such as but not limited to non allowed anti psychotic medications, tricyclic antidepressants and/or Class I antiarrhythmics
  • Patients receiving medications (within the last 6 weeks prior to screening) that are metabolized by CYP2D6 and have the potential of reducing seizure threshold

    • Other criteria apply, please contact the investigator for more information
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   Denmark,   France,   Germany,   Italy,   Netherlands,   Poland,   Russian Federation,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02006472
Other Study ID Numbers  ICMJE TV7820-CNS-20002
2013-001888-23 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prilenia Therapeutics Development Ltd.
Study Sponsor  ICMJE Prilenia Therapeutics Development Ltd.
Collaborators  ICMJE
  • European Huntington's Disease Network
  • Huntington Study Group
Investigators  ICMJE
Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
PRS Account Prilenia Therapeutics Development Ltd.
Verification Date March 2019

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