A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke
1 other identifier
interventional
83
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2012
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 21, 2012
CompletedFirst Posted
Study publicly available on registry
May 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
March 10, 2014
CompletedJanuary 22, 2016
December 1, 2015
9 months
May 21, 2012
January 28, 2014
December 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs)
A TEAE is defined as any adverse event with date of onset (or worsening) on or after the start-date of double-blind treatment through 7 days after the last dose of double-blind treatment. The severity categories of mild, moderate or severe, are defined below: * Mild is defined as causing no limitation of usual activities * Moderate is defined as causing some limitation of usual activities * Severe is defined as causing inability to carry out usual activities
up to 36 days
Other Outcomes (7)
Walking Speed Measured by the Timed 25 Foot Walk Test (T25FW)
Screening visit, Days 1, 8, 15, 22, 29 and 36
Motor and Sensory Function as Measured by the Fugl-Meyer Assessment (FMA)
Screening visit, Days 1, 8, 15, 22, 29, and 36
Manual Dexterity as Measured by the Box and Block Test
Days 1, 8, 15, 22, 29, and 36
- +4 more other outcomes
Study Arms (2)
placebo/dalfampridine-ER
PLACEBO COMPARATORSubjects 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
dalfampridine-ER/placebo
PLACEBO COMPARATORSubjects 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
Interventions
Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Acorda Site #011
Birmingham, Alabama, 35294, United States
Acorda Site #018
La Jolla, California, 92103, United States
Acorda Site #016
Newport Beach, California, 92663, United States
Acorda Site #006
Fairfield, Connecticut, 06824, United States
Acorda Site #002
Atlantis, Florida, 33462, United States
Acorda Site #015
Fort Lauderdale, Florida, 33308, United States
Acorda Site #003
Decatur, Georgia, 30033, United States
Acorda Site #021
Lexington, Kentucky, 40513, United States
Acorda Site #009
Boston, Massachusetts, 02118, United States
Acorda Site #017
Saginaw, Michigan, 48604, United States
Acorda Site #020
Great Falls, Montana, 59405, United States
Acorda Site #023
Reno, Nevada, 89502, United States
Acorda Site #022
New Brunswick, New Jersey, 08901, United States
Acorda Site #019
Buffalo, New York, 14220, United States
Acorda Site #007
West Haverstraw, New York, 10993, United States
Acorda Site #004
White Plains, New York, 10605, United States
Acorda Site #013
Charlotte, North Carolina, 28207, United States
Acorda Site #001
Philadelphia, Pennsylvania, 19104, United States
Acorda Site #008
Norfolk, Virginia, 23507, United States
Acorda Site #010
Bellevue, Washington, 98004, United States
Related Publications (1)
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.
PMID: 23652269DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Acorda Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Mathews Adera, MD
Acorda Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2012
First Posted
May 25, 2012
Study Start
May 1, 2012
Primary Completion
February 1, 2013
Study Completion
March 1, 2013
Last Updated
January 22, 2016
Results First Posted
March 10, 2014
Record last verified: 2015-12