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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011560
Receipt No. 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

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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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email tadamasa@bri.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013453


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