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Study to Determine the Safety and Tolerability of Varenicline (Chantix®) in Treating Spinocerebellar Ataxia Type 3

NCT00992771 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-06-18

No results posted yet for this 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.

Conditions

  • Spinocerebellar Ataxia Type 3

Interventions

DRUG

varenicline

up to 1mg BID for 8 weeks

DRUG

placebo

placebo matching varenicline, up to 1mg BID for 8 weeks

Sponsors & Collaborators

  • National Ataxia Foundation

    collaborator OTHER

  • Bob Allison Ataxia Research Center (BAARC)

    collaborator UNKNOWN

  • Pfizer

    collaborator INDUSTRY

  • University of South Florida

    lead OTHER

Principal Investigators

  • Theresa Zesiewicz, MD · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00992771 on ClinicalTrials.gov