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A Study of ACR16 for the Treatment of Patients With Huntington's Disease (HART)
This study is ongoing, but not recruiting participants.
First Received: July 24, 2008   Last Updated: May 18, 2010   History of Changes
Sponsor: NeuroSearch A/S
Information provided by: NeuroSearch A/S
ClinicalTrials.gov Identifier: NCT00724048
  Purpose

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


Condition Intervention Phase
Huntington Disease
Drug: ACR16
Phase II
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Control: Placebo Control
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 NeuroSearch A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 220
Study Start Date: October 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: ACR16
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).
2: Experimental Drug: ACR16
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).
3: Experimental Drug: ACR16
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).
4: Placebo Comparator Drug: ACR16
Week 1-4: ACR16 Placebo - one placebo capsule daily. Week 5-12: ACR16 Placebo - two placebo capsules taken as two separate doses.

Detailed Description:

A striking observation in HD is the wide variety of symptoms and signs. The clinical picture includes motor impairments, cognitive dysfunction, behavioral disturbance, personality change and susceptibility to mental disorder. The nature of the movement disorder in HD is highly complex involving, among others, hyper- and hypokinetic features, apraxia and motor impersistence. The primary objective in the present study is to confirm whether ACR16 is efficacious in improving voluntary motor function in HD, symptoms that seem to be most important for the functional disability associated with the disorder and to determine the most effective dose. To achieve this, subjects are randomized to ACR16 10mg bid, ACR16 22.5mg bid, ACR16 45mg bid or placebo treatment in equal proportions in a parallel design for treatment duration of 12 weeks.

  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
NeuroSearch A/S
Investigators
Study Director: Joakim Tedroff, MD NeuroSearch A/S
  More Information

No publications provided

Responsible Party: NeuroSearch ( Joakim Tedroff / Medical Director )
ClinicalTrials.gov Identifier: NCT00724048     History of Changes
Other Study ID Numbers: ACR16 C009
Study First Received: July 24, 2008
Last Updated: May 18, 2010
Health Authority: United States: Food and Drug Administration;   Canada: Ethics Review Committee;   Canada: Health Canada

Keywords provided by NeuroSearch A/S:
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 September 07, 2010