Dalfampridine and Gait in Spinocerebellar Ataxias
- Conditions
- Spinocerebellar Ataxias Type 1Spinocerebellar Ataxias Type 3Spinocerebellar Ataxias Type 2Spinocerebellar Ataxias Type 6
- Interventions
- Drug: Placebo
- Registration Number
- NCT01811706
- Lead Sponsor
- University of Florida
- Brief Summary
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.
- Detailed Description
Twenty spinocerebellar ataxia patients will be randomized to receive either Dalfampridine or placebo over a total period of 10 weeks. After entering the study, patients will return every 2 weeks for evaluation. After four weeks, intervention will be stopped and patient will enter a 2-week wash out period where they do not take any drug. Then, patients will be given the opposite treatment (Dalfampridine or placebo) and this "crossover" study will be performed for another 4 weeks. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo, Then Dalfampridine Placebo Participant first receive Placebo tablet orally every 12 hours, for a 4 weeks period. After a washout period of 2 weeks, they then receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks. Dalfampridine and then placebo Placebo Participant first receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks. After a washout period of 2 weeks, they then receive Placebo tablet orally every 12 hours, for a 4 weeks period. Dalfampridine and then placebo Dalfampridine Participant first receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks. After a washout period of 2 weeks, they then receive Placebo tablet orally every 12 hours, for a 4 weeks period. Placebo, Then Dalfampridine Dalfampridine Participant first receive Placebo tablet orally every 12 hours, for a 4 weeks period. After a washout period of 2 weeks, they then receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks.
- Primary Outcome Measures
Name Time Method Change in Timed 25 Feet Walking Test (T25FW) Baseline and 4 weeks after Dalfampridine or placebo 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.
- Secondary Outcome Measures
Name Time Method Biomechanical Assessment of Gait (BAG)-Stride Length Baseline and 4 weeks after Dalfampridine or placebo 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.
Change in Scale of Assessment and Rating of Ataxia (SARA) Baseline and 4 weeks after Dalfampridine or placebo 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.
Trial Locations
- Locations (1)
University of Florida
🇺🇸Gainesville, Florida, United States