UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011560 |
|---|---|
| Receipt number | R000013453 |
| Scientific Title | Trial of varenicline (Champix) for the treatment of spinocerebellar degeneration |
| Date of disclosure of the study information | 2013/08/26 |
| Last modified on | 2015/09/28 13:07:34 |
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Basic information
Public title
Trial of varenicline (Champix) for the treatment of spinocerebellar degeneration
Acronym
Varenicline trial for SCD
Scientific Title
Trial of varenicline (Champix) for the treatment of spinocerebellar degeneration
Scientific Title:Acronym
Varenicline trial for SCD
Region
| Japan |
Condition
Condition
spinocerebellar degeneration (SCD)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective of this open trial was to evaluate the efficacy and safety of varenicline (Champix) in patients with spinocerebellar degeneration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
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)
Key secondary outcomes
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)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
[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
Interventions/Control_2
[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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayoshi Tada |
Organization
Brain Research Institute, Niigata University
Division name
Department of Neurology
Zip code
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-City, Niigata 951-8585, Japan
TEL
025-227-0665
tadamasa@bri.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayoshi Tada |
Organization
Brain Research Institute, Niigata University
Division name
Department of Neurology
Zip code
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-City, Niigata 951-8585, Japan
TEL
025-227-0665
Homepage URL
tadamasa@bri.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
新潟大学医歯学総合病院
Niigata University Medical and Dental Hospital
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2013 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 22 | Day |
Last modified on
| 2015 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013453
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
