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What is a Clinical Trial?by Huntington Study Group (HSG)
Understanding Clinical Trials by NIH ClinicalTrials.gov
List of Clinical Trials by NIH ClinicalTrials.gov
List of Clinical Trials by Huntington Project
Trial information at NIH ClincalTrials.gov
Trial status: This trial is active, enrolling participants who are positive or at risk for the HD gene but have not developed symptoms. This will be a phase II trial to test the safety of varying doses of creatine (10 to 30 grams) compared to placebo.
FDA Phase: Phase II conducted in a two part sequential protocol.
Sponsor: Massachusetts General Hospital and Avicena.
Trial Design: Part 1: Randomized, double blind placebo controlled dosing study of 60 participants who receive either placebo or creatine starting at 10 grams and increasing to 30 grams or highest tolerated dose. At the completion of the dose study, participants will enter the second part of the study, a year long open-label (no placebos) study.
Outcome Measures: Blood studies of oxidative biomarkers and morphmetric MRI. Morphometric MRI measures whole brain volume.
Location: This trial is offered only in Boston at the Massachusetts General Hospital. More information on this trial at ClinicalTrials.gov.
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