Clinical trial NCT01605825: A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke
Official title: A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemic Stroke
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-05-25
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: up to 36 days
Secondary outcomes:
Other outcomes:
measure: Walking Speed Measured by the Timed 25 Foot Walk Test (T25FW)
timeFrame: Screening visit, Days 1, 8, 15, 22, 29 and 36
measure: Motor and Sensory Function as Measured by the Fugl-Meyer Assessment (FMA)
timeFrame: Screening visit, Days 1, 8, 15, 22, 29, and 36
measure: Manual Dexterity as Measured by the Box and Block Test
timeFrame: Days 1, 8, 15, 22, 29, and 36
measure: Assistance Required to Perform Activities of Daily Living (ADL) by the Functional Independence Measure (FIM) Scale
timeFrame: Days 1, 8, 15, 22, 29, and 36
measure: Subject Global Impression (SGI) Scale
timeFrame: Days 8, 15, 22, 29 and 36
measure: Clinician Global Impression (CGI) Scale
timeFrame: Days 8, 15, 22, 29 and 36
measure: Hand Strength as Measured by the Grip Test and Pinch Tests
timeFrame: Days 1, 8, 15, 22, 29, and 36
Locations:
city: Birmingham
country: United States
facility: Acorda Site #011
state: Alabama
city: La Jolla
country: United States
facility: Acorda Site #018
state: California
city: Newport Beach
country: United States
facility: Acorda Site #016
state: California
city: Fairfield
country: United States
facility: Acorda Site #006
state: Connecticut
city: Atlantis
country: United States
facility: Acorda Site #002
state: Florida
city: Fort Lauderdale
country: United States
facility: Acorda Site #015
state: Florida
city: Decatur
country: United States
facility: Acorda Site #003
state: Georgia
city: Lexington
country: United States
facility: Acorda Site #021
state: Kentucky
city: Boston
country: United States
facility: Acorda Site #009
state: Massachusetts
city: Saginaw
country: United States
facility: Acorda Site #017
state: Michigan
city: Great Falls
country: United States
facility: Acorda Site #020
state: Montana
city: Reno
country: United States
facility: Acorda Site #023
state: Nevada
city: New Brunswick
country: United States
facility: Acorda Site #022
state: New Jersey
city: Buffalo
country: United States
facility: Acorda Site #019
state: New York
city: West Haverstraw
country: United States
facility: Acorda Site #007
state: New York
city: White Plains
country: United States
facility: Acorda Site #004
state: New York
city: Charlotte
country: United States
facility: Acorda Site #013
state: North Carolina
city: Philadelphia
country: United States
facility: Acorda Site #001
state: Pennsylvania
city: Norfolk
country: United States
facility: Acorda Site #008
state: Virginia
city: Bellevue
country: United States
facility: Acorda Site #010
state: Washington
Study officials:
affiliation: Acorda Therapeutics
name: Mathews Adera, MD
role: STUDY_DIRECTOR
References:
citation: Iaci JF, Parry TJ, Huang Z, Finklestein SP, Ren J, Barrile DK, Davenport MD, Wu R, Blight AR, Caggiano AO. Dalfampridine improves sensorimotor function in rats with chronic deficits after middle cerebral artery occlusion. Stroke. 2013 Jul;44(7):1942-50. doi: 10.1161/STROKEAHA.111.000147. Epub 2013 May 7.