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| Sponsor: | University of South Florida |
|---|---|
| Collaborators: |
Friedreich's Ataxia Research Alliance Pfizer |
| Information provided by: | University of South Florida |
| ClinicalTrials.gov Identifier: | NCT00803868 |
Purpose
The purpose of this study is to determine if varenicline is effective in treating symptoms of Friedreich's ataxia.
| Condition | Intervention | Phase |
|---|---|---|
|
Friedreich's Ataxia |
Drug: varenicline Drug: placebo |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pilot Study of Varenicline (Chantix®) in the Treatment of Friedreich's Ataxia |
| Estimated Enrollment: | 32 |
| Study Start Date: | May 2009 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Varenicline
|
Drug: varenicline
up to 1mg po bid for 9 weeks
|
|
2: Placebo Comparator
Placebo
|
Drug: placebo
placebo matching study drug up to 1mg po bid
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
CBC, CMP, and diabetes lab results not indicative of clinically relevant abnormalities (results within the past 6 months prior to screening). These would include but are not limited to:
Electrolytes (Chloride, Sodium, Potassium) within laboratory defined normal limits.
Hemoglobin, white cell count, platelet count and fasting glucose within laboratory defined normal limits. Creatinine must be (≤1.5 mg/dl).
ALT (6-40 u/l) and AST (10-30 u/l) must be less than 2 times normal limit
Exclusion Criteria:
Contacts and Locations| Contact: Kelly Sullivan, MSPH | 813-974-5909 | kbarber@hsc.usf.edu |
| United States, Florida | |
| University of South Florida | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Kelly Sullivan, MSPH 813-974-5909 kbarber@health.usf.edu | |
| United States, Pennsylvania | |
| The Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Baali Muganga 267-426-9738 mailto:mugangab@email.chop.edu | |
| Principal Investigator: | Theresa Zesiewicz, M.D. | University of South Florida |
More Information
| Responsible Party: | University of South Florida ( Theresa Zesiewicz, MD ) |
| Study ID Numbers: | 6 |
| Study First Received: | December 4, 2008 |
| Last Updated: | January 11, 2010 |
| ClinicalTrials.gov Identifier: | NCT00803868 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Metabolic Diseases Spinal Cord Diseases Nervous System Diseases Central Nervous System Diseases Mitochondrial Diseases Brain Diseases Neurodegenerative Diseases Dyskinesias |
Signs and Symptoms Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Friedreich Ataxia Ataxia Neurologic Manifestations Cerebellar Diseases Spinocerebellar Degenerations |