Trial record 2 of 3 for:    ACR16

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
  Purpose

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


Condition Intervention Phase
Huntington Disease
Drug: ACR16 10 mg
Drug: ACR16 22.5 mg
Drug: ACR16 45 mg
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 227
Study Start Date: October 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

Drug: ACR16 10 mg
ACR16 capsules: 10mg twice daily
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).

Drug: ACR16 22.5 mg
ACR16 capsules: 22.5mg twice daily
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).

Drug: ACR16 45 mg
ACR16 capsules: 45mg twice daily
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.

Other: Placebo
Placebo capsules

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724048

  Show 28 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Director: Joakim Tedroff, MD NeuroSearch A/S
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00724048     History of Changes
Other Study ID Numbers: ACR16 C009
Study First Received: July 24, 2008
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration
Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Teva Pharmaceutical Industries:
Huntington Disease

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014