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Sponsored by: |
NeuroSearch A/S |
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Information provided by: | NeuroSearch A/S |
ClinicalTrials.gov Identifier: | NCT00665223 |
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's Disease |
Drug: ACR16 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicentre, Multinational, Randomized, Double-Blind, Parallel-Group Study Comparing ACR16 Versus Placebo for the Symptomatic Treatment of Huntington's Disease |
Estimated Enrollment: | 420 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: ACR16
First four weeks - ACR16 45mg qd - one active 45mg capsule daily After four weeks - ACR16 45mg qd - one active 45mg capsule and one placebo capsule taken as two separate doses. |
2: Experimental |
Drug: ACR16
First four weeks - ACR16 45mg qd - one active 45mg capsule daily After four weeks - ACR16 45mg bd - two active 45mg capsules taken as two separate doses. |
3: Placebo Comparator |
Drug: Placebo
First four weeks - ACR16 Placebo - one placebo capsule daily After four weeks - ACR16 Placebo - two placebo capsules taken as two separate doses. |
The primary objective in the present study is to confirm whether ACR16 is efficacious in improving voluntary motor function in Huntington's disease, symptoms that seem to be most important for the functional disability associated with the disorder. To achieve this, patients are randomised to ACR16 45mg qd, ACR16 45mg bd, or placebo treatment in equal proportions in a parallel design for treatment duration of 26 weeks.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mark Sanderson | 44-017-8645-8127 | info@qctr.co.uk |
Responsible Party: | Neurosearch ( Joakim Tedroff / Medical Director ) |
Study ID Numbers: | ACR16 C008 |
Study First Received: | April 22, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00665223 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Afssaps - French Health Products Safety Agency; Belgium: Federal Agency for Medicinal Products and Health Products; Austria: Agency for Health and Food Safety; Portugal: National Pharmacy and Medicines Institute; Spain: Spanish Agency of Medicines; Italy: The Italian Medicines Agency |
Huntington's Disease |
Ganglion Cysts Huntington disease Basal Ganglia Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Dyskinesias Cognition Disorders Chorea |
Delirium, Dementia, Amnestic, Cognitive Disorders Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Mental Disorders Movement Disorders Dementia Huntington Disease Delirium |
Nervous System Diseases |