Trial of varenicline (Champix) for the treatment of spinocerebellar degeneration

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000011560
• Date of registration: 26/08/2013
• Prospective Registration: Yes
• Primary sponsor: Niigata University
• Public title: Trial of varenicline (Champix) for the treatment of spinocerebellar degeneration
• Scientific title: Trial of varenicline (Champix) for the treatment of spinocerebellar degeneration - Varenicline trial for SCD
• Date of first enrolment: 2013/08/30
• Target sample size: 40
• Recruitment status: Recruiting
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013453
• Study type: Interventional
• Study design: Cross-over Randomized
• Phase: Phase I,II

Countries of recruitment

Japan

Contacts

• Name: Masayoshi Tada
• Affiliation: Brain Research Institute, Niigata University Department of Neurology

• Name: Masayoshi Tada
• Affiliation: Brain Research Institute, Niigata University Department of Neurology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1) any unstable illness or concomitant medical condition that precluded participation in this study, including other disorders that may affect gait or balance (stroke, arthritis, or others) 2) pregnancy or lactation 3) smoking at the time of screening or within the past 12 months 4) concurrent treatment with monoamine oxidase inhibitors, bupropion, or nicotine patches 5) dementia or other psychiatric illness (including psychosis, bipolar disorder, untreated depression (Beck Depression Inventory score 21), or history of suicide attempt) or any other illness that would have precluded a patient from giving informed consent (Mini-Mental State Examination score 24) 6) use of varenicline within the previous 30 days 7) ataxia derived from any cause other than genetically confirmed SCA and CCA (including but not limited to alcoholism, head injury, multiple sclerosis, and multiple system atrophy)

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

spinocerebellar degeneration (SCD)

Intervention(s)

[High-dose Group] Oral administration of varenicline 1-7 days 0.5 mg/day 8-14 days 1.0mg/day 15-21 days 1.5mg/day 22-56 days 2.0 mg/day 57-63 days 1.0 mg/day 64-70 days 0.5 mg/day 71-84 days Wash-out period 85-154 days 0.5 mg/day
[Low-dose Group] Oral administration of varenicline 1-70 days 0.5 mg/day 71-84 days Wash-out period 85-91 days 0.5 mg/day 92-98 days 1.0mg/day 99-105 days 1.5mg/day 106-140 days 2.0 mg/day 141-147 days 1.0 mg/day 148-154 days 0.5 mg/day

Primary Outcome(s)

1) SARA (the Scale for the Assessment and Rating of Ataxia) 2) Visually guided tracking test with repeated linear motion 3) Visually guided tracking test with repeated circular motion 4) Tapping test 5) Stabilometry 6) Timed Up and Go Test (TUG)

Secondary Outcome(s)

7) Beck Depression Inventory (BDI) 8) Beck Anxiety Inventory (BAI) 9) Clinical Global Impressions (CGI) 10) Patient Global Impressions of change (PGIC) 11) Short-Form 36 (SF-36)

Source(s) of Monetary Support

Niigata University

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 30/09/2015