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

Purpose

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.

Condition	Intervention	Phase
Ischemic Stroke	Drug: dalfampridine-ER	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke

Resource links provided by NLM:

Drug Information available for: Dalfampridine

U.S. FDA Resources

Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:

Safety and tolerability of dalfampridine-ER in subjects with chronic deficits after ischemic stroke [ Time Frame: 38 days (days 1, 8, 15, 22, 29, and 36) ] [ Designated as safety issue: No ]
Safety and tolerability will be assessed by reviewing the rate of adverse events. Changes in vital signs and laboratory test results compared to baseline using descriptive statistics

Secondary Outcome Measures:

Change in walking speed measured by the Timed 25 Foot Walk test (T25FW) [ Time Frame: Days 8, 15, 22, 29 and 36 compared to day 1 ] [ Designated as safety issue: No ]
Motor and sensory function as measured by the Fugl-Meyer Assessment (FMA) [ Time Frame: Screening visit, Days 1, 8, 15, 22, 29, and 36 ] [ Designated as safety issue: No ]
Manual dexterity as measured by the Box and Block Test [ Time Frame: Days 1, 8, 15, 22, 29, and 36 ] [ Designated as safety issue: No ]
Assistance required to perform activities of daily living (ADL) by the Functional Independence Measure (FIM) scale [ Time Frame: Days 1, 8, 15, 22, 29, and 36 ] [ Designated as safety issue: No ]
Subject Global Impression (SGI) scale [ Time Frame: Days 8, 15, 22, 29 and 36 ] [ Designated as safety issue: No ]
Clinician Global Impression (CGI) scale [ Time Frame: Days 8, 15, 22, 29 and 36 ] [ Designated as safety issue: No ]

Enrollment:	83
Study Start Date:	May 2012
Study Completion Date:	March 2013
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: placebo/dalfampridine-ER 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	Drug: dalfampridine-ER Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
Placebo Comparator: dalfampridine-ER/placebo 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	Drug: dalfampridine-ER Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605825

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, California
University of California, San Diego
La Jolla, California, United States, 92103
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
United States, Connecticut
Associated Neurologists of Southern CT, PC
Fairfield, Connecticut, United States, 06824
United States, Florida
JEM Research Institute
Atlantis, Florida, United States, 33462
Neurologic Consultants, PA
Fort Lauderdale, Florida, United States, 33308
United States, Georgia
NeuroStudies.net
Decatur, Georgia, United States, 30033
United States, Kentucky
Associates in Neurology, PSC
Lexington, Kentucky, United States, 40513
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02474
United States, Montana
Advanced Neurology Specialists
Great Falls, Montana, United States, 59405
United States, Nevada
Renown Neuroscience Institute
Reno, Nevada, United States, 89502
United States, New Jersey
UMDNJ -Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
United States, New York
Mercy Hospital of Buffalo
Buffalo, New York, United States, 14220
Helen Hayes Hospital
West Haverstraw, New York, United States, 10993
The Burke Rehabilitation Hospital
White Plains, New York, United States, 10605
United States, North Carolina
Neuroscience & Spine Institute
Charlotte, North Carolina, United States, 28207
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
Sentara Medical Group/Sentara Neurology Specialists
Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Acorda Therapeutics

Investigators

Study Director:

Gustavo Suarez, MD

Acorda Therapeutics

More Information

No publications provided

Responsible Party:	Acorda Therapeutics
ClinicalTrials.gov Identifier:	NCT01605825 History of Changes
Other Study ID Numbers:	DALF-PS-1003
Study First Received:	May 21, 2012
Last Updated:	April 4, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

Brain Infarction
Brain Ischemia
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013