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NCT00992771 · ClinicalTrials.gov registry record · Phase 2
Study to Determine the Safety and Tolerability of Varenicline (Chantix®) in Treating Spinocerebellar Ataxia Type 3
A Phase 2 study, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT00992771 is a Phase 2 study that has completed, run by University of South Florida. The registered enrollment target is 20 participants.
The verdict
NCT00992771, a Phase 2 study, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
Spinocerebellar ataxia (SCA) is a group of inherited disorders characterized by cerebellar degeneration leading to imbalance, incoordination, speech difficulties and problems with walking. Recently, individual case reports have suggested that varenicline, a drug used in smoking cessation, produces substantial improvement in patients with several inherited ataxias. A modest response was noted in 5 patients with SCA, suggesting that it is potentially efficacious in this disorder as well. Although this agent is available for off-label use, the severe side effects noted with its use and the lack of long-term toxicity data demand that it be systematically assessed. The present study will test whether varenicline is safe and potentially efficacious in a heterogeneous cohort of adults with SCA.
Interventions
- DRUG placebo
- DRUG varenicline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00992771
The ClinicalTrials.gov registry entry for NCT00992771 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00992771 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00992771 about?
NCT00992771 is a clinical study titled "Study to Determine the Safety and Tolerability of Varenicline (Chantix®) in Treating Spinocerebellar Ataxia Type 3". Spinocerebellar ataxia (SCA) is a group of inherited disorders characterized by cerebellar degeneration leading to imbalance, incoordination, speech difficulties and problems with walking. Recently, individual case reports have suggested that varenicline, a drug used in smoking cessation, produces s...
What is the current status of trial NCT00992771?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2009-10. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00992771?
The interventions under investigation include: placebo (DRUG), varenicline (DRUG).
Who is sponsoring clinical trial NCT00992771?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
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