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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02494778
Recruitment Status : Terminated (This study served its purpose in providing considerable safety data. The decision to terminate the studies was not based on any new or emerging safety concern.)
First Posted : July 10, 2015
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Prilenia Therapeutics Development Ltd.

Tracking Information
First Submitted Date  ICMJE July 7, 2015
First Posted Date  ICMJE July 10, 2015
Last Update Posted Date March 6, 2019
Actual Study Start Date  ICMJE September 24, 2015
Actual Primary Completion Date January 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
Percentage of participants with adverse events [ Time Frame: 364 weeks ]
Study participation will continue until the drug has been authorized for marketing by the respective regulatory authorities in the USA or Europe; or the study is discontinued for medical/scientific (risk-benefit) or commercial reasons.
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
Percentage of participants with adverse events [ Time Frame: 52 weeks ]
Study participation will continue until the drug has been authorized for marketing by the respective regulatory authorities in the USA or Europe; or the study is discontinued for medical/scientific (risk-benefit) or commercial reasons.
Change History Complete list of historical versions of study NCT02494778 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
  • Proportion of subjects (%) who prematurely discontinued from the study [ Time Frame: 364 weeks ]
  • Proportion of subjects (%) who prematurely discontinued from the study due to AEs [ Time Frame: 364 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
  • Proportion of subjects (%) who prematurely discontinued from the study [ Time Frame: 52 weeks ]
  • Proportion of subjects (%) who prematurely discontinued from the study due to AEs [ Time Frame: 52 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease
Official Title  ICMJE A Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients With Huntington's Disease (Open PRIDE-HD)
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Huntington's Disease
Intervention  ICMJE Drug: Pridopidine
45 mg BID
Other Name: TV7820
Study Arms  ICMJE Experimental: Pridopidine
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.
Intervention: Drug: Pridopidine
Publications * Cohen S, Waks Z, Elm JJ, Gordon MF, Grachev ID, Navon-Perry L, Fine S, Grossman I, Papapetropoulos S, Savola JM. Characterizing patient compliance over six months in remote digital trials of Parkinson's and Huntington disease. BMC Med Inform Decis Mak. 2018 Dec 20;18(1):138. doi: 10.1186/s12911-018-0714-7.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: December 12, 2017)
248
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2015)
400
Actual Study Completion Date  ICMJE January 12, 2018
Actual Primary Completion Date January 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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,   France,   Germany,   Italy,   Netherlands,   Poland,   Russian Federation,   United Kingdom,   United States
Removed Location Countries Denmark
 
Administrative Information
NCT Number  ICMJE NCT02494778
Other Study ID Numbers  ICMJE TV7820-CNS-20016
2015-000904-24 ( 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 Not Provided
Responsible Party Prilenia Therapeutics Development Ltd.
Study Sponsor  ICMJE Prilenia Therapeutics Development Ltd.
Collaborators  ICMJE Not Provided
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