HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus

• Register: EUCTR
• Last refreshed on: 14 August 2012
• Main ID: EUCTR2009-018123-32-GB
• Date of registration: 18/03/2010
• Prospective Registration: Yes
• Primary sponsor: Medivation, Inc
• Public title: HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus
• Scientific title: HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus
• Date of first enrolment: 14/05/2010
• Target sample size: 350
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-018123-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Denmark, Germany, Italy, Netherlands, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Have successfully completed 26 weeks of blinded treatment in the HORIZON study and completed Week 26 assessments;
2. Are willing and able to give informed consent. If the subject is not competent, a mentally competent legally acceptable representative must provide informed consent on their behalf, and the subject should provide assent;
3. Have a caregiver who assists the subject, can oversee study drug administration, and provide written informed consent;
4. If female, are either a) of childbearing potential and compliant in using adequate birth control or b) not of childbearing potential. Adequate birth control is defined as consistent practice of an effective and accepted method of contraception (hormone-based, intrauterine device, barrier contraception [e.g., condom or occlusive cap {diaphragm or cervical/vault caps} with spermicidal foam/gel/film/cream/suppository], vasectomized partner, or sexual abstinence) throughout the duration of the study. Women not of childbearing potential may have undergone menopause or permanent sterilization (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation). Menopause is defined as one year without menses. If the subject’s menopausal status is in question, a follicle-stimulating hormone (FSH) level of > 40 milli international units per milliliter (mIU/mL) must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented;
5. If male, is either a) of reproductive potential and compliant in using adequate birth control through 30 days after the last dose of study drug or b) not of reproductive potential. Surgical sterilization must be documented. Adequate birth control for males is defined as a condom and spermicidal gel or foam, or abstinence throughout the duration of the study;
6. Capable of complying with study procedures, including being able to swallow tablets the size of the study drug.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Have any major medical illness or unstable medical condition that may interfere with their ability to comply with study procedures and abide by study restrictions, or may interfere with the ability to interpret safety information;
2. Are pregnant or lactating females;
3. Plan to use bupropion, clozapine, or non-selective antihistamines such as chlorpheniramine and diphenhydramine during this extension study;
4. Plan to participate in another study of an investigational agent for HD;
5. Have a Columbia Suicide Severity Rating Scale response of “Yes” to question four (4) or five (5) of the Suicidal Ideation category during the Week 26 visit for HORIZON;
6. Have any condition or reason that, in the opinion of the investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Huntington disease
MedDRA version: 12.1 Level: LLT Classification code 10020469 Term: Huntington's chorea

Intervention(s)

Product Name: Dimebon
Product Code: Dimebon
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Dimebon dihydrochloride
CAS Number: 97657-92-6
Current Sponsor code: Dimebon
Other descriptive name: Dimebon dihydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Product Name: Dimebon
Product Code: Dimebon
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Dimebon dihydrochloride
CAS Number: 97657-92-6
Current Sponsor code: Dimebon
Other descriptive name: Dimebon dihydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Main Objective: • To evaluate the long-term safety of dimebon (latrepirdine) in Huntington disease (HD) subjects who have successfully completed 26 weeks of blinded treatment in the HORIZON protocol (DIM20).

Secondary Objective: • To observe the long-term functional and motor symptoms of HD during open-label treatment with dimebon, using the Unified Huntington Disease Rating Scale (UHDRS) Total Functional Capacity (TFC) and Total Motor scores

Primary end point(s): Safety Outcomes
The following assessments will occur at each study visit to monitor safety:
• Adverse events will be recorded;
• Vital signs will be monitored;
• The Columbia Suicide Severity Rating Scale will be performed;
• Brief physical examinations will be performed;
• Clinical laboratory testing will be performed;
• ECG monitoring will be performed.
The following assessments will occur to evaluate disease progression:
• UHDRS TFC will be performed at Weeks 26, 52, and every six months thereafter;
• UHDRS Total Motor Score will be performed at Weeks 26 (as part of the HORIZON study), 52, and every six months thereafter.

Secondary ID(s)

2009-018123-32-DE

DIM20EXT