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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 350

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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