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| Sponsor: | NeuroSearch A/S |
|---|---|
| Information provided by: | NeuroSearch A/S |
| ClinicalTrials.gov Identifier: | NCT00665223 |
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's Disease |
Drug: ACR16 Drug: Placebo |
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 Multicentre, Multinational, Randomized, Double-blind, Parallel-group Study Comparing ACR16 Versus Placebo for the Symptomatic Treatment of Huntington's Disease |
| Enrollment: | 437 |
| Study Start Date: | April 2008 |
| Study Completion Date: | June 2011 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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. |
| Experimental: 2 |
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. |
| Placebo Comparator: 3 |
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.
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| Austria | |
| LKH -Univ. Klinikum Graz, Universitaetsklinik fur Psychiatrie Graz | |
| Graz, Styria, Austria, 8036 | |
| Innsbruck Medical University, Anichstraße 35 | |
| Innsbruck, Tyrol, Austria, A-6020 | |
| Belgium | |
| University Hospital Gasthuisberg | |
| Leuven, Flemish Brabant, Belgium, 3000 | |
| France | |
| Hôpital Purpan, Place Docteur-Baylac, Bâtiment F | |
| Toulouse Cedex 9, Midi-Pyrénées region, France, 31059 | |
| CHU Roger Salengro | |
| Lille Cedex, Nord-Pas de Calais, France, 59037 | |
| Hôpital Nord, CHU d'Amiens, Service de Neurologie | |
| Amiens Cedex 1, Picardie, France, 80054 | |
| CHU La Timone, 264 Rue Saint Pierre | |
| Marseille Cedex 05, Provence-Alpes-Cote d'Azur, France, 13385 | |
| Germany | |
| Universitätsklinik Ulm, Neurologie/ Oberer Eselberg 45/1 | |
| Ulm, Baden-Württemberg, Germany, 89081 | |
| Klinikum rechts der Isar der Technischen Universität München, Neurologische Klinik und Poliklinik, Ismaninger Str. 22 | |
| München, Bavaria, Germany, 81675 | |
| Isar Amper Klinikum gemeinnützige GmbH, Klinik Taufkirchen (Vils), Bräuhausstr.5 | |
| Taufkirchen (Vils), Bavaria, Germany, 84416 | |
| St. Josef Hospital, Ruhr University Bochum, Gudrunstraße 56 | |
| Bochum, North Rhine-Westphalia, Germany, 44791 | |
| Westfaelische Wilhelms-Universitaet Muenster, Klinik fur Neurologie | |
| Muenster, North Rhine-Westphalia, Germany, 48149 | |
| Universitat Dresden, Klinikum Carl Gustav Carus, Fetscherstr. 74 | |
| Dresden, Saxony, Germany, 01307 | |
| Klinik für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Schumannstrasse 20/21 | |
| Berlin, Germany, 10117 | |
| Italy | |
| Fondazione IRCCS Istituto Nazionale Neurologico "Carlos Besta", Department of Movement Disorders, 11 via Celoria | |
| Milano, Lombardy, Italy, 20133 | |
| IRCCS Neuromed, Localita Camarelle | |
| Pozzilli, Molise, Italy, 86077 | |
| Portugal | |
| University Hospital of Coimbra, Av. Rissaya Barreto | |
| Coimbra, Baixo Mondego, Portugal, 3000-075 | |
| Centro de Estudos Egas Moniz, Faculdade de Medicina de Lisboa, Av. Prof. Egas Moniz | |
| Lisboa, Portugal, 1649-028 | |
| Spain | |
| Hospital Mútua de Terrassa, C/ Castell | |
| Terrassa, Catalonia, Spain, 08225 | |
| Hospital Clinic of Barcelona, Calle Villarroel, 170 | |
| Barcelona, Spain, 08036 | |
| Hospital Ramon y Cajal, Carretera Colemenar km 9.100 | |
| Madrid, Spain, 28034 | |
| Hospital Universitario La Fe, Avda. Campanar 21, | |
| Valencia, Spain, 46009 | |
| United Kingdom | |
| R&D Headquarters, Barberry Centre, 25 Vincent Drive | |
| Birmingham, England/West Midlands, United Kingdom, B15 2SG | |
| Department of Clinical Genetics, St Mary's Hospital, Hathersage Road | |
| Manchester, North West England, United Kingdom, M13 9WL | |
| First Floor Argyll House, Fosterhill, Cornhill Road | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZR | |
| SE Scotland Genetic Service, Western General Hospital, Crewe Road | |
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |
| Churchill Hospital, Old Road, Headington | |
| Oxford, South East England, United Kingdom, OX3 7LJ | |
| Academic Neurology Unit, E Floor Medical School Beech Hill Road | |
| Sheffield, South Yorkshire, United Kingdom, S10 2RX | |
| Institute of Human Genetics, Centre for Life, Central Parkway | |
| Newcastle on Tyne, Tyne and Wear, United Kingdom, NE1 3BZ | |
| Cardiff University School of Medicine, Department of Neurology & Medical Genetics, Heath Park | |
| Cardiff, Wales, United Kingdom, CF14 4XN | |
| Cambridge Centre for Brain repair, Cambridge University | |
| Cambridge, United Kingdom, CB2 2PY | |
More Information
| Responsible Party: | Joakim Tedroff / Medical Director, Neurosearch |
| ClinicalTrials.gov Identifier: | NCT00665223 History of Changes |
| Other Study ID Numbers: | ACR16 C008 |
| Study First Received: | April 22, 2008 |
| Last Updated: | July 14, 2011 |
| 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 |
|
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 |