Clinical trial NCT00920946: A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Huntington Disease
Keywords: Huntington
Dimebon
HD
Huntingtin
Lead sponsor: Medivation, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2009-06-15
Enrollment: 403
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if Dimebon is safe and effective for the treatment of cognitive impairment in Huntington disease.

Detailed description: This study is a multicenter Phase 3, randomized, double-blind, placebo-controlled safety and efficacy study of Dimebon treatment in subjects with Huntington disease (HD). The study will evaluate Dimebon 20 mg three times daily (TID) administered orally (PO) for six months (26 weeks) compared with matching placebo TID for the primary safety and efficacy analyses. Safety and tolerability will be assessed by recording of adverse events and by monitoring of vital signs, physical examinations, safety laboratory evaluations, and 12-lead electrocardiogram(ECG)assessments.

Eligibility criteria: Inclusion Criteria:

* Have clinical features of HD and a CAG polyglutamate repeat expansion ≥ 36
* Have cognitive impairment as noted by the following:

  1. A Screening MMSE AND a baseline (pre-dose) MMSE score between 10 and 26 (inclusive); and
  2. A subjective assessment of cognitive impairment with decline from pre-HD levels by the Investigator after interviewing the subject and caregiver;
* Are willing and able to give informed consent
* Aged 30 years or older
* Have a caregiver who assists/spends time with the subject at least five days per week for at least three hours per day and has intimate knowledge of the subject's cognitive, functional, and emotional states, and of the subject's personal care.

Exclusion Criteria:

* Had onset of symptoms prior to age 18
* Have any major medical illness or unstable medical condition within 180 days of screening that may interfere with the subject's ability to comply with study procedures and abide by study restrictions, or with the ability to interpret safety data

Primary outcomes:
measure: A comparison between the mean changes from baseline in the Dimebon 20 mg TID treatment group and the placebo group on the MMSE
timeFrame: Week 26
measure: A comparison of the distributions of the CIBIC-plus (ADCS CGIC)in the Dimebon 20 mg TID treatment group and the placebo group
timeFrame: Week 26
Secondary outcomes:
measure: A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the NPI
timeFrame: Week 26
measure: A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the ADCS-ADL
timeFrame: Week 26
measure: A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the UHDRS'99 Total Motor Score
timeFrame: Week 26
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Davis
country: United States
state: California
city: Irvine
country: United States
state: California
city: La Jolla
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Gainsville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Indianapolis
country: United States
state: Indiana
city: Kansas City
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Charlestown
country: United States
state: Massachusetts
city: Golden Valley
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Winstom-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Milwaukee
country: United States
state: Wisconsin
city: Wentworthville
country: Australia
state: New South Wales
city: Melbourne
country: Australia
state: Victoria
city: Perth
country: Australia
city: Vancouver
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Copenhagen
country: Denmark
city: Oberer Eslebberg
country: Germany
state: Ulm
city: Aachen
country: Germany
city: Bochum
country: Germany
city: Hamburg
country: Germany
city: Stockholm
country: Sweden
city: Birmingham
country: United Kingdom
Study officials:
References:
citation: HORIZON Investigators of the Huntington Study Group and European Huntington's Disease Network. A randomized, double-blind, placebo-controlled study of latrepirdine in patients with mild to moderate Huntington disease. JAMA Neurol. 2013 Jan;70(1):25-33. doi: 10.1001/2013.jamaneurol.382.