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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00712426 |
The purpose of this study is to assess the effect of creatine on slowing the worsening of HD symptoms and to assess the safety of creatine in long-term use.
Subjects will participate in fifteen (15) study visits and twenty eighteen (18) telephone contacts over three years.
Eligible subjects will receive either 30 grams powdered creatine monohydrate per day or matching placebo for a total of 36 months.
Condition | Intervention | Phase |
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Huntington's Disease |
Drug: Creatine Monohydrate (HD-02) 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: | Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E) |
Estimated Enrollment: | 650 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2013 |
Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Eligible subjects randomized into this arm will receive up to 40 grams powdered creatine monohydrate per day for a total of 36 months
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Drug: Creatine Monohydrate (HD-02)
Eligible subjects randomized into this arm will receive up to 40 grams powdered creatine monohydrate per day for a total of 36 months. Doses will be escalated
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2: Placebo Comparator
Eligible subjects randomized into this arm will receive up to 40 grams of placebo per day for a total of 36 months
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Drug: placebo
Eligible subjects randomized into this arm will receive up to 40 grams powdered creatine monohydrate per day for a total of 36 months. Doses will be escalated
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Additional Exclusion Criteria for Imaging Sites:
Contact: Alejandra M Rodriguez, RN, BSN | 617-726-5892 | arodriguez16@partners.org |
Contact: Emily Flagg | (585) 273-4243 | emily.flagg@ctcc.rochester.edu |
Principal Investigator: | Steven M Hersch, MD, PhD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Steven M. Hersch, MD, PhD ) |
Study ID Numbers: | 2007P000827, UO1AT000613 |
Study First Received: | July 8, 2008 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00712426 |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration; Canada: Canadian Institutes of Health Research; Canada: Ethics Review Committee; Canada: Health Canada; Canada: Ministry of Health & Long Term Care, Ontario; Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: Human Research Ethics Committee; Australia: National Health and Medical Research Council; United Kingdom: Department of Health; United Kingdom: Food Standards Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: National Health Service; United Kingdom: Research Ethics Committee; New Zealand: Food Safety Authority; New Zealand: Health Research Council; New Zealand: Health and Disability Ethics Committees; New Zealand: Institutional Review Board; New Zealand: Medsafe |
Huntington's Disease Creatine Mitochondrial Dysfunction Total Functional Capacity UHDRS |
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 |