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A Study of Pridopidine (ACR16) for the Treatment of Patients With Huntington's Disease (HART)

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: NCT00724048
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Tracking Information
First Submitted Date  ICMJE July 24, 2008
First Posted Date  ICMJE July 29, 2008
Last Update Posted Date July 22, 2016
Study Start Date  ICMJE October 2008
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2013)
Sum score of items 4-10 and 13-15 of the UHDRS motor assessment [ Time Frame: 26 Weeks ]
The primary objective is to assess the effects of ACR16 on voluntary motor function in HD patients, as defined as the sum score of items 4-10 and 13-15 of the UHDRS motor assessment (a modified motor score in MS) at 26 weeks of treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2008)
To assess the effects of ACR16 on voluntary motor function in HD subjects. [ Time Frame: At week 4, 5 and 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2013)
  • Clinical Global Impressions (CGI) [ Time Frame: At 4, 8, 12 and 26 weeks ]
    The effects of ACR16 on CGI, cognitive function, behaviour and symptoms of depression and anxiety. CGI has two components-the CGI-Severity, which rates illness severity, and the CGI-Improvement, which rates change from the initiation (baseline) of treatment.
  • Adverse event profile [ Time Frame: 30 weeks ]
    Safety and tolerability assessed from adverse event profile
Original Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2008)
  • To assess the effects of ACR16 on clinical global impression of change (CGI-C), cognitive function, behavior and symptoms of depression and anxiety at 12 weeks of treatment [ Time Frame: At 12 weeks of treatment ]
  • To assess the safety and tolerability of ACR16 [ Time Frame: At week 1, 4, 5, 8, 12 and 14 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Pridopidine (ACR16) for the Treatment of Patients With Huntington's Disease
Official Title  ICMJE A Multi-center, North American, Randomized, Double-blind, Parallel Group Study Comparing Three Doses of ACR16 Versus Placebo for the Symptomatic Treatment of Huntington Disease (HART)
Brief Summary The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic treatment of Huntington's Disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
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: ACR16 10 mg
    ACR16 capsules: 10mg twice daily
    Other Name: pridopidine
  • Drug: ACR16 22.5 mg
    ACR16 capsules: 22.5mg twice daily
  • Drug: ACR16 45 mg
    ACR16 capsules: 45mg twice daily
  • Other: Placebo
    Placebo capsules
Study Arms  ICMJE
  • Experimental: ACR16 10 mg

    Participants receive one ACR16 10mg twice daily:

    First four weeks - ACR16 10mg qd - one active 10mg capsule daily. After four weeks - ACR16 10mg bid - two active 10mg capsules taken as two separate doses (20mg ACR16 per day).

    Intervention: Drug: ACR16 10 mg
  • Experimental: ACR16 22.5 mg

    Participants receive one ACR16 22.5mg capsule twice daily:

    First four weeks - ACR16 22.5mg qd - one active 22.5mg capsule daily. After four weeks - ACR16 22.5mg bid - two active 22.5mg capsules taken as two separate doses (45mg ACR16 per day).

    Intervention: Drug: ACR16 22.5 mg
  • Experimental: ACR16 45 mg

    Participants receive one ACR16 45mg capsule twice daily:

    First four weeks - ACR16 45mg qd - one active 45mg capsule daily. After four weeks - ACR16 45mg bid - two active 45mg capsule taken as two separate doses (90mg ACR16 per day).

    Intervention: Drug: ACR16 45 mg
  • Placebo Comparator: Placebo

    Weeks 1-4, Participants receive a one placebo capsule once daily for four weeks.

    Weeks 5-26, Participants receive a one placebo capsule taken twice daily as two separate doses.

    Intervention: Other: 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 Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2011)
227
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2008)
220
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able to provide written Informed Consent prior to any study related procedure, including consent to genotyping of the CYP2D6 gene.
  • Clinical features of HD, and a positive family history and/or the presence of ≥ 36 CAG repeats in the Huntington gene.
  • Male or female age ≥ 30 years.
  • Willing and able to take oral medication and to comply with the study specific procedures.
  • Ambulatory, being able to travel to the assessment center, and judged by the Investigator as likely to be able to continue to travel for the duration of the study.
  • Availability of a caregiver or family member to accompany the subject to two visits.
  • A sum of ≥ 10 points on the mMS at the screening visit.
  • For subjects taking allowed antidepressants or other psychotropic medication , the dosing of medication must have been kept constant for at least 6 weeks before enrollment.

Exclusion Criteria:

  • Treatment with any antipsychotic medication (neuroleptics) within 8 weeks of enrollment, or at any time point during the study period.
  • Use of tetrabenazine within 12 weeks of enrollment, or at any time during the study period.
  • Treatment with any investigational product within 4 weeks of enrollment.
  • Use of tricyclic antidepressants or class I antiarrhythmics within 6 weeks of enrollment, or at any time during the study period.
  • Use of concomitant medication that may lower the seizure threshold within 6 weeks of enrollment, or at any time during the study period .
  • Use of metoclopramide within 12 weeks of enrollment, or at any time during the study period.
  • Subjects currently receiving deep brain stimulation (DBS).
  • Subjects with a history of surgical procedures aiming to improve the symptoms of Huntington disease, such as neural transplantations, lesions of the central nervous system, infusions of neurotrophic agents or previous attempts of deep brain stimulation.
  • Subjects previously randomized into this study.
  • A prolonged QTc interval at Screening Visit (defined as a QTc interval of > 450 msec for males or > 470 msec for females), or other clinically significant heart conditions as judged by the investigator.
  • Creatinine clearance <40mL/min as measured at the screening visit.
  • Any clinically significant, abnormal, baseline laboratory result which in the opinion of the Investigator, affects the subjects' suitability for the study or puts the subject at risk if he/she enters the study.
  • Clinically significant hepatic or renal impairment.
  • Subjects with a known history of epilepsy or a history of febrile seizure(s) or seizure(s) of unknown cause.
  • Severe intercurrent illness, which, in the opinion of the Investigator, may put the subject at risk when participating in the trial or may influence the results of the trial or affect the subjects' ability to take part in the trial.
  • Alcohol and/or drug abuse as defined by DSM IV-TR criteria for Substance Abuse - this includes the illicit use of cannabis within the last 12 months prior to Screening Visit
  • Subjects with suicidal ideation as defined as a positive score on criteria for major depressive episode, item A9 on the DSM -IV-TR criteria for a Major Depressive Episode
  • Females who are pregnant or lactating or who intend to become pregnant during the study period.
  • Females who are of child bearing potential and not taking adequate contraceptive precautions are excluded from the trial. (Females of child bearing potential taking acceptable contraceptive precautions can be included)
  • Known allergy to any ingredients of the trial medication or placebo
  • Any previous participation in a clinical study with ACR16.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00724048
Other Study ID Numbers  ICMJE ACR16 C009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries
Study Sponsor  ICMJE Teva Pharmaceutical Industries
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Joakim Tedroff, MD NeuroSearch A/S
PRS Account Teva Pharmaceutical Industries
Verification Date July 2016

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