Dimebon in Mild-to-Moderate Huntington Disease 'DIM20'
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease
IRAS ID
26506
Sponsor organisation
Medivation, Inc.
Eudract number
2009-011800-44
Clinicaltrials.gov Identifier
Research summary
This is a multicenter Phase 3, randomized, double-blind, placebo-controlled safety and efficacy study of Dimebon (20 mg administered orally three times daily for 26 weeks) in the treatment of patients with mild-to-moderate Huntington disease (HD). Patients will be required to participate in the study with a caregiver who assists/spends time with them at least five days per week and for at least three hours per day. Approximately 350 patients will be randomised to receive Dimebon or placebo (175 patients in each group). Patients will be assessed for efficacy using questionnaires such as the Mini Mental State Examination (MMSE), the Clinician??s Interview-Based Impression of Severity (CIBIS)/CIBIC-plus, the Neuropsychiatric Inventory (NPI), the Alzheimer??s Disease Cooperative Study, Activities of Daily Living (ADCS-ADL) and the United Huntington Disease Rating Scale (UHDRS??99). Safety and tolerability will be checked by recording adverse events and by monitoring blood pressure, heart rate, physical examinations, safety laboratory evaluations and ECGs. In addition, the Columbia Suicide Severity Rating Scale will be used at each study visit to check the patient??s suicidal ideation. An independent Data Monitoring Committee will monitor safety data in the trial by blinded treatment group on an ongoing basis and may request treatment group unblinding if concerns arise. Blood samples will be collected measure Dimebon concentrations throughout the study, so as to investigate the relationship between levels of Dimebon and efficacy and safety outcomes. Subjects who complete the 26-week treatment course will be offered the opportunity to continue into an open-label study, under a separate protocol, which will allow them to receive Dimebon until marketing authorization is given. Patients who do not wish to continue to the extension study will discuss continuing treatment with their physicians but will return to the clinic 30 days after the end of the study for follow-up safety checks.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
09/H0502/100
Date of REC Opinion
7 Oct 2009
REC opinion
Further Information Favourable Opinion