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

• Conditions: Huntington disease; MedDRA version: 12.1Level: LLTClassification code 10020469Term: Huntington's chorea

• Registration Number: EUCTR2009-018123-32-SE
• Lead Sponsor: Medivation, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-10
• Last Update Posted: 14 August 2012

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. Subject is willing and able to give informed consent for study participation. If the subject is not competent, a trustee or administrator previously appointed by the patient and approved by the court to provide for the care and well being of the subject must provide informed consent on his/her behalf, the subject’s closest relative must provide informed consent, and the subject must 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 subjects are male, are either a) of reproductive potential and compliant in using adequate birth control through 30 days after the last dose of study drug or are b) not of reproductive potential. Surgical sterilization must be documented. Adequate birth control for males is defined as a condom in combination with another double barrier method of contraception, or a condom in combination with an acceptable method of contraception for the female partner as specified in inclusion criterion 4 throughout 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