A randomized trial of varenicline (Champix) for the treatment of cognitive and affective symptoms in Huntington's Disease

Phase 2

Recruiting

• Conditions: Huntington's Disease; Neurological - Other neurological disorders

• Registration Number: ACTRN12616001611415
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age 18 years to 65 years.
2. Non-smoker
3. Outpatients with Huntington’s Disease diagnosed by a movement disorder specialist
4. Unified Huntington’s Disease Rating Scale (UHDRS) Score between 15-30
5. Ability to ambulate without assistance.
6. Stable dose of current regular medication for the management of HD symptoms for at least 30 days prior to trial entry and for the duration of the trial.

Exclusion Criteria

1. Legal incapacity or limited legal capacity
2. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
3. Significant renal or hepatic impairment.
4. Participant with life expectancy of less than 6 months, or who is inappropriate for placebo medication.
5. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
6. Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
7. Patients with a history of substance abuse.
8. Concurrent treatment with any MAOIs, Wellbutrin, antiretroviral medications, immunosupressants, cancer chemotherapy, nicotine patches or nicotine delivery products such as e-cigarettes.
9. Dementia or other psychiatric illness at a level that, in the opinion of the clinician, prevents the patient from giving informed consent (Mini Mental Status Exam score less than 34 and, Addenbrooks Cognitive Examination-Revised (ACE-R) score <65).
10. Presence of psychosis, bipolar disorder, untreated depression (BDI greater than or equal to 21).

Study & Design

• Study Type: Interventional
• Study Design: Not specified