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

Huntington Disease Clinical Trial

— HORIZON  

Official title:

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920946
• Other study ID #: DIM20
• Status: Completed
• Phase: Phase 3
• First received: June 12, 2009
• Last updated: October 11, 2016
• Start date: July 2009

Study information

• Verified date: October 2016
• Source: Medivation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Drug:
• Dimebon
20 mg Dimebon orally TID

Other:
• Placebo
Orally TID

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medivation, Inc.	Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Denmark,  Germany,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A comparison between the mean changes from baseline in the Dimebon 20 mg TID treatment group and the placebo group on the MMSE		Week 26	No
Primary	A comparison of the distributions of the CIBIC-plus (ADCS CGIC)in the Dimebon 20 mg TID treatment group and the placebo group		Week 26	No
Secondary	A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the NPI		Week 26	No
Secondary	A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the ADCS-ADL		Week 26	No
Secondary	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		Week 26	No

External Links

•   Study website