A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke

Acorda Therapeutics

Status and phase: Completed; Phase 2

Conditions: Ischemic Stroke

Treatments: Drug: placebo/dalfampridine-ER; Drug: dalfampridine-ER/placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01605825

DALF-PS-1003

Details and patient eligibility

About

This is a multi-center, safety and tolerability study in subjects with chronic stable sensorimotor deficits after ischemic stroke. It has been designed as a double-blind, placebo-controlled, 2-period crossover study.

Enrollment: 83 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of a stable sensorimotor deficit due to an ischemic stroke, as confirmed by the Investigator with supportive prior imaging findings (MRI/ CT scan)
• ≥ 6 months post-stroke
• Have a body mass index (BMI) ranging between 18.0 - 35.0 kg/m,2 inclusive
• Stable concomitant medication therapy regimen within 4 weeks of screening visit

Exclusion criteria

• History of seizures, except simple febrile seizures
• Moderate or severe renal impairment as defined by a calculated creatinine clearance of ≤ 50 mL/minute using the Cockcroft-Gault Equation
• Botulinum toxin use within 2 months prior to the Screening Visit
• Orthopedic surgical procedures in any of the extremities within the past 6 months
• Diagnosis of multiple sclerosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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83 participants in 2 patient groups, including a placebo group

placebo/dalfampridine-ER

Placebo Comparator group

Description:

Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36

Treatment:

Drug: placebo/dalfampridine-ER

dalfampridine-ER/placebo

Placebo Comparator group

Description:

Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36

Treatment:

Drug: dalfampridine-ER/placebo