Spinocerebellar Ataxias Type 1 Clinical Trial
Official title:
Therapeutic Effect of Dalfampridine on Gait Incoordination in Spinocerebellar Ataxias- A Randomized, Double-blinded, Placebo-controlled, Crossover Clinical Trial
Investigators expect there will be improvement in walking speed and steadiness after taking Dalfampridine, thereby improving activities of daily living and enhancing social and occupational functions for patients with spinocerebellar ataxia.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Individuals at age 18 years or older. - Individuals who can provide the informed consent - Genetic confirmed definite spinocerebellar ataxias (SCA) - Able to complete two trials of the timed 25-foot walk at screening Exclusion Criteria: - Patients who has severe ataxia and unable to ambulate. - Any orthopedic condition that would affect motor performance. - Patients with secondary ataxia from general medical disorders - Individuals who have major psychiatric disorders that prevents compliance - History of epilepsy - Patients with active drug or alcohol use or dependence that would interfere with adherence to study requirements - Inability or unwillingness of subject or legal guardian/representative to give written informed consent. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Florida | Gainesville | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of Florida | Acorda Therapeutics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Timed 25 Feet Walking Test (T25FW) | The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time, in seconds, is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. Baseline values are recorded twice. One was at the beginning of the intervention. The second was 2 weeks after washout period and before the second intervention. | Baseline and 4 weeks after Dalfampridine or placebo | No |
| Secondary | Change in Scale of Assessment and Rating of Ataxia (SARA) | Scale for the assessment and rating of ataxia (SARA) is a clinical scale that is based on a semiquantitative assessment of cerebellar ataxia on an impairment level. SARA has 8 items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test. SARA score ranges from 0 to 40, with higher scores indicating more severe disease. | Baseline and 4 weeks after Dalfampridine or placebo | No |
| Secondary | Biomechanical Assessment of Gait (BAG)-Stride Length | Biomechanical Assessment of Gait is a sensitive, quantitative movement analysis system. Stride length was analyzed. Baseline values are recorded twice. One was at the beginning of the intervention. The second was 2 weeks after washout period and before the second intervention. | Baseline and 4 weeks after Dalfampridine or placebo | No |