Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy

Acorda Therapeutics

Status and phase: Completed; Phase 1

Conditions: Cerebral Palsy (CP)

Treatments: Drug: dalfampridine-ER 10mg; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01468350

DALF-CP-1002

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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35 participants in 4 patient groups, including a placebo group

(PART A) AB: dalfampridine-ER 10mg then placebo

Placebo Comparator group

Description:

Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart

Treatment:

Drug: dalfampridine-ER 10mg

Other: Placebo

(PART A) BA: placebo then dalfampridine-ER 10mg

Placebo Comparator group

Description:

Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart

Treatment:

Drug: dalfampridine-ER 10mg

Other: Placebo

(PART B) AB: dalfampridine-ER 10mg then placebo

Placebo Comparator group

Description:

Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo

Treatment:

Drug: dalfampridine-ER 10mg

Other: Placebo

(PART B) BA: Placebo then dalfampridine-ER 10mg

Placebo Comparator group

Description:

Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg

Treatment:

Drug: dalfampridine-ER 10mg

Other: Placebo