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| 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 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) |
| Enrollment: | 227 |
| Study Start Date: | October 2008 |
| Study Completion Date: | June 2011 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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).
|
| Experimental: 2 |
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).
|
| Experimental: 3 |
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).
|
| Placebo Comparator: 4 |
Drug: ACR16
Week 1-4: ACR16 Placebo - one placebo capsule daily. Week 5-12: ACR16 Placebo - two placebo capsules taken as two separate doses.
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 28 Study Locations| Study Director: | Joakim Tedroff, MD | NeuroSearch A/S |
More Information
| Responsible Party: | Joakim Tedroff / Medical Director, NeuroSearch |
| ClinicalTrials.gov Identifier: | NCT00724048 History of Changes |
| Other Study ID Numbers: | ACR16 C009 |
| Study First Received: | July 24, 2008 |
| Last Updated: | July 14, 2011 |
| Health Authority: | United States: Food and Drug Administration; Canada: Ethics Review Committee; Canada: Health Canada |
|
Huntington Disease |
|
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 |