Dalfampridine and Gait in Spinocerebellar Ataxias

University of Florida

Status: Completed

Conditions: Spinocerebellar Ataxias Type 2; Spinocerebellar Ataxias Type 3; Spinocerebellar Ataxias Type 6; Spinocerebellar Ataxias Type 1

Treatments: Drug: Placebo; Drug: Dalfampridine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01811706

1133511 (Other Identifier)

20121107

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Dalfampridine and then placebo

Experimental group

Description:

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.

Treatment:

Drug: Dalfampridine

Drug: Placebo

Placebo, Then Dalfampridine

Experimental group

Description:

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.

Treatment:

Drug: Dalfampridine

Drug: Placebo