spinocerebellar degeneration (SCD)
Conditions
Interventions
[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
Sponsors
Niigata University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Spinocerebellar ataxias (SCA3, SCA6, SCA1, SCA2, SCA31, and CCA), adult patients 2) normal results for complete metabolic panels and complete blood counts, serum creatine kinase, and EKG taken within 6 months before screening 3) stable doses of all medications for 30 days before study entry and for the duration of the study 4) ability to ambulate with or without assistance 5) a score of 15 or lower on the Scale for the Assessment and Rating of Ataxia (SARA) total score 6) and score of 4 or lower on the gait subsection of the SARA rating scale
Exclusion 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactMasayoshi Tada
Brain Research Institute, Niigata University Department of Neurology
Outcome results
None listed