N/A N=20 Randomized Quadruple-blind Treatment

Dalfampridine and Gait in Spinocerebellar Ataxias

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

Bottom Line

View on ClinicalTrials.gov: NCT01811706 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2015

Primary outcome: Primary: Change in Timed 25 Feet Walking Test (T25FW) — 23.7; 24.4; -1.1; -0.3 second — p=>0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Dalfampridine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Timed 25 Feet Walking Test (T25FW)	23.7; 24.4; -1.1; -0.3	>0.05
SECONDARY Change in Scale of Assessment and Rating of Ataxia (SARA)	10.0; 10.1; 0.6; 0.8	>0.05
SECONDARY Biomechanical Assessment of Gait (BAG)-Stride Length	112.7; 111.8; 1.6; 4.0	>0.05

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01811706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.