A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease (HORIZON)

This study has been completed.

Sponsor:

Collaborator:

Pfizer

Information provided by:

Medivation, Inc.

ClinicalTrials.gov Identifier:

NCT00920946

First received: June 12, 2009

Last updated: April 13, 2011

Last verified: April 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 12, 2009
Last Updated Date	April 13, 2011
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 12, 2009)	A comparison between the mean changes from baseline in the Dimebon 20 mg TID treatment group and the placebo group on the MMSE [ Time Frame: Week 26 ] [ Designated as safety issue: No ] A comparison of the distributions of the CIBIC-plus (ADCS CGIC)in the Dimebon 20 mg TID treatment group and the placebo group [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00920946 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 12, 2009)	A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the NPI [ Time Frame: Week 26 ] [ Designated as safety issue: No ] A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the ADCS-ADL [ Time Frame: Week 26 ] [ Designated as safety issue: No ] 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 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease
Official Title ^ICMJE	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Huntington Disease
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	Huntington Disease
Intervention ^ICMJE	Drug: Dimebon 20 mg Dimebon orally TID Other: Placebo Orally TID
Study Arm (s)	Placebo Comparator: Placebo Intervention: Other: Placebo Experimental: Dimebon Intervention: Drug: Dimebon
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Have clinical features of HD and a CAG polyglutamate repeat expansion ≥ 36 Have cognitive impairment as noted by the following: A Screening MMSE AND a baseline (pre-dose) MMSE score between 10 and 26 (inclusive); and 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
Gender	Both
Ages	30 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Canada, Denmark, Germany, Sweden, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00920946
Other Study ID Numbers ^ICMJE	DIM20
Has Data Monitoring Committee	Yes
Responsible Party	Lynn Seely, MD / Chief Medical Officer, Medivation, Inc.
Study Sponsor ^ICMJE	Medivation, Inc.
Collaborators ^ICMJE	Pfizer
Investigators ^ICMJE	Not Provided
Information Provided By	Medivation, Inc.
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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