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| Sponsored by: |
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 |
| Genetics Home Reference related topics: | chorea-acanthocytosis familial encephalopathy with neuroserpin inclusion bodies Huntington disease McLeod neuroacanthocytosis syndrome |
| MedlinePlus related topics: | Huntington's Disease |
| 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.
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| Contact: Lesley Sexton | 44-017-8645-8127 | info@qctr.co.uk |
| Austria, Styria | |||||
| LKH -Univ. Klinikum Graz, Universitätsklinik fϋr Psychiatrie Graz | Recruiting | ||||
| Graz, Styria, Austria, 8036 | |||||
| Principal Investigator: Raphael Bonelli, MD, Univ-Doz | |||||
| Austria, Tyrol | |||||
| Innsbruck Medical University, Anichstraße 35 | Recruiting | ||||
| Innsbruck, Tyrol, Austria, A-6020 | |||||
| Principal Investigator: Klaus Seppi, MD | |||||
| Belgium, Flemish Brabant | |||||
| University Hospital Gasthuisberg | Recruiting | ||||
| Leuven, Flemish Brabant, Belgium, 3000 | |||||
| Principal Investigator: Wim Vandenberghe, Professor | |||||
| Germany | |||||
| Klinik für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Schumannstrasse 20/21 | Not yet recruiting | ||||
| Berlin, Germany, 10117 | |||||
| Principal Investigator: Josef Priller, Professor | |||||
| Germany, Baden-Württemberg | |||||
| Universitätsklinik Ulm, Neurologie/ Oberer Eselberg 45/1 | Recruiting | ||||
| Ulm, Baden-Württemberg, Germany, 89081 | |||||
| Principal Investigator: Bernhard Landwehrmeyer, Professor | |||||
| Germany, Bavaria | |||||
| Isar Amper Klinikum gemeinnützige GmbH, Klinik Taufkirchen (Vils), Bräuhausstr.5 | Not yet recruiting | ||||
| Taufkirchen (Vils), Bavaria, Germany, 84416 | |||||
| Principal Investigator: Matthias Dose, Professor | |||||
| Germany, North Rhine-Westphalia | |||||
| Westfälische Wilhelms-Universität Münster, Klinik für Neurologie | Recruiting | ||||
| Münster, North Rhine-Westphalia, Germany, 48149 | |||||
| Principal Investigator: Ralf Reilmann, MD | |||||
| St. Josef Hospital, Ruhr University Bochum, Gudrunstraße 56 | Recruiting | ||||
| Bochum, North Rhine-Westphalia, Germany, 44791 | |||||
| Principal Investigator: Carsten Saft, MD | |||||
| Germany, Saxony | |||||
| Universitat Dresden, Klinikum Carl Gustav Carus, Fetscherstr. 74 | Recruiting | ||||
| Dresden, Saxony, Germany, 01307 | |||||
| Principal Investigator: Alexander Storch, Professor | |||||
| United Kingdom | |||||
| Cambridge Centre for Brain repair, Cambridge University | Recruiting | ||||
| Cambridge, United Kingdom, CB2 2PY | |||||
| Principal Investigator: Roger Barker, MD | |||||
| United Kingdom, England/West Midlands | |||||
| Queen Elizabeth Psychiatric Hospital | Recruiting | ||||
| Birmingham, England/West Midlands, United Kingdom, B15 2QZ | |||||
| Principal Investigator: Hugh Rickards, MD | |||||
| United Kingdom, North West England | |||||
| Department of Clinical Genetics, St Mary's Hospital, Hathersage Road | Recruiting | ||||
| Manchester, North West England, United Kingdom, M13 9WL | |||||
| Principal Investigator: David Craufurd, MD | |||||
| United Kingdom, Scotland | |||||
| First Floor Argyll House, Fosterhill, Cornhill Road | Not yet recruiting | ||||
| Aberdeen, Scotland, United Kingdom, AB25 2ZR | |||||
| Principal Investigator: Sheila Simpson, MD | |||||
| SE Scotland Genetic Service, Western General Hospital, Crewe Road | Not yet recruiting | ||||
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |||||
| Principal Investigator: Mary Porteous, MD | |||||
| United Kingdom, Tyne and Wear | |||||
| Institute of Human Genetics, Centre for Life, Central Parkway | Not yet recruiting | ||||
| Newcastle on Tyne, Tyne and Wear, United Kingdom, NE1 3BZ | |||||
| Principal Investigator: William Barker, MD | |||||
| United Kingdom, Wales | |||||
| Cardiff University School of Medicine, Department of Neurology & Medical Genetics, Heath Park | Not yet recruiting | ||||
| Cardiff, Wales, United Kingdom, CF14 4XN | |||||
| Principal Investigator: Anne Rosser, Professor | |||||
| NeuroSearch A/S |
More Information
| Responsible Party: | Neurosearch ( Joakim Tedroff / Medical Director ) |
| Study ID Numbers: | ACR16 C008 |
| First Received: | April 22, 2008 |
| Last Updated: | August 26, 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 |
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