A Trial of Memantine as Symptomatic Treatment for Early Huntington Disease (MITIGATE-HD)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Trial of Memantine as Symptomatic Treatment for Early Huntington Disease; a Phase IIb Study|
- Utility of TRACK-HD study endpoints in a clinical trial setting [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]To examine the clinical utility of novel trial endpoints (such as Putaminal NAA measured by MRS) developed in the TRACK-HD study in the setting of a placebo-controlled therapeutic trial.
- Neuropsychiatric and Cognitive Test Scores [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]To examine effect of memantine versus placebo on the scores of: a) the irritability and agitation/aggression sub-categories of the Neuropsychiatric Inventory (NPI), and also the total NPI, b) cognitive tests: Circle Tracing , Symbol Digit Modality, Stroop Word Reading, and Spot the Change, c) total HD-ADL, d) total UHDRS, and the UHDRS sub-scale: Cognitive, Behavioural, Functional, and Independence scales. e) In patients recruited at the UBC study site, the effect on striatal N-acetyl aspartate levels (a measure of neuronal dysfunction) will be assessed by Magnetic Resonance Spectroscopy.
|Study Start Date:||September 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Memantine
NMDA Receptor Antagonist
oral tablet, 1 BID, 24 weeks
|Placebo Comparator: Sugar pill||
oral tablet, 1 BID, 24 weeks
TRACK-HD was a multi-centre, multi-national, prospective, observational study of pre-manifest and early Huntington's disease (HD) with a control group of volunteers not carrying the HD mutation. The goal of the project was to contribute essential methodology that will form the basis for clinical trials in pre-manifest and early HD. TRACK-HD complemented existing observational studies (e.g., Predict-HD, PHAROS, COHORT), sharing some features, but also having areas of unique emphasis.
The UBC site recruited 90 subjects including 30 control subjects, 30 asymptomatic pre-manifest HD gene carriers and 30 subjects with early symptoms of HD (stage 1 or 2). All subjects were assessed using the TRACK-HD battery at baseline, 1 year, 2 years, and 3 years. Following the fourth visit (3 year assessment), the TRACK-HD study will be completed, and the 30 subjects with early symptoms of HD will be invited to enroll in the MITIGATE-HD Study.
The MITIGATE-HD study is a single center Phase IIb,out-patient,randomized, double-blind, placebo-controlled trial of memantine treatment in subjects with Huntington disease (HD). The study will evaluate Memantine 10 mg two times daily (BID) administered orally (PO) for six months (24 weeks) compared with matching placebo BID. Safety and tolerability will be assessed by recording of adverse events and by monitoring of vital signs, physical examinations, and suicidality risk scores.
The TRACK-HD assessment battery will be administered to all subjects after six months of study drug administration. The effects of memantine will be evaluated both against placebo as well as compared to the previous 3 years of observational data from the TRACK-HD Study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458470
|Canada, British Columbia|
|The Centre for Huntington Disease|
|Vancouver, British Columbia, Canada, V6T 2B5|
|Principal Investigator:||Blair R. Leavitt, MD,CM,FRCPC||University of British Columbia|
|Study Chair:||Michael R. Hayden, MD,ChB,PhD||The University of British Columbia|