Phase 1 N=11 Randomized Triple-blind Treatment

Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy

Cerebral Palsy (CP)

Bottom Line

View on ClinicalTrials.gov: NCT01468350 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2014

Primary outcome: Primary: Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) — 1; 2; 6; 9 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: dalfampridine-ER 10mg (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Acorda Therapeutics
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP)	1; 2; 6; 9; 0; 0	—
SECONDARY Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function	—	—

Summary

A double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (CP) to evaluate the safety and tolerability and the effect of dalfampridine extended release (ER) tablets on sensorimotor function

Eligibility Criteria

Inclusion Criteria

A diagnosis of CP
No previous use of any dalfampridine formulation
Ability to perform all the required study procedures. Subjects should be capable of fully extending and flexing both hands

Exclusion Criteria

Presence of any progressive neurological disease
Severe CP defined as the requirement to use a wheelchair at all times and a care taker for constant assistance in daily activities. This definition includes spastic quadriplegia
Pregnant or breastfeeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01468350). 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.