Dalfampridine and Gait in Spinocerebellar Ataxias

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spinocerebellar Ataxias Type 1 Spinocerebellar Ataxias Type 2 Spinocerebellar Ataxias Type 3 Spinocerebellar Ataxias Type 6

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dalfampridine and then 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.

Group Type EXPERIMENTAL

Dalfampridine

Intervention Type DRUG

Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period

Placebo

Intervention Type DRUG

Placebo will be administered orally every 12 hours, for a 4 week period.

Placebo, Then 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.

Group Type EXPERIMENTAL

Dalfampridine

Intervention Type DRUG

Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period

Placebo

Intervention Type DRUG

Placebo will be administered orally every 12 hours, for a 4 week period.

Interventions

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Dalfampridine

Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period

Intervention Type DRUG

Placebo

Placebo will be administered orally every 12 hours, for a 4 week period.

Intervention Type DRUG

Other Intervention Names

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Ampyra Sugar Pill

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No