ClinicalTrials.Veeva

Menu

Dalfampridine and Gait in Spinocerebellar Ataxias

University of Florida logo

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems