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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00724048
First received: July 24, 2008
Last updated: March 28, 2013
Last verified: March 2013

July 24, 2008
March 28, 2013
October 2008
June 2011   (final data collection date for primary outcome measure)
Sum score of items 4-10 and 13-15 of the UHDRS motor assessment [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
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.
To assess the effects of ACR16 on voluntary motor function in HD subjects. [ Time Frame: At week 4, 5 and 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00724048 on ClinicalTrials.gov Archive Site
  • Clinical Global Impressions (CGI) [ Time Frame: At 4, 8, 12 and 26 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Safety and tolerability assessed from adverse event profile
  • 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 ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of ACR16 [ Time Frame: At week 1, 4, 5, 8, 12 and 14 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study of ACR16 for the Treatment of Patients With Huntington's Disease
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)

The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic treatment of Huntington's Disease.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Huntington Disease
  • Drug: ACR16 10 mg
    ACR16 capsules: 10mg twice daily
  • Drug: ACR16 22.5 mg
    ACR16 capsules: 22.5mg twice daily
  • Drug: ACR16 45 mg
    ACR16 capsules: 45mg twice daily
  • Other: Placebo
    Placebo capsules
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
227
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00724048
ACR16 C009
Yes
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
Not Provided
Study Director: Joakim Tedroff, MD NeuroSearch A/S
Teva Pharmaceutical Industries
March 2013

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