A Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets.

Post-Ischemic Stroke Clinical Trial

— MILESTONE?  

Official title:

This is a Multi-center, Double-blind, Three Arm, Parallel Group, Placebo-controlled, Randomized Study Designed to Evaluate the Efficacy, Safety and Tolerability of Dalfampridine.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271217
• Other study ID #: DALF-PS-1016
• Status: Completed
• Phase: Phase 3
• Start date: December 2014
• Est. completion date: October 2016

Study information

• Verified date: September 2017
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine the effect of two dose strengths of dalfampridine-Extended Release (ER) tablets, taken twice daily for 12 weeks, on stable walking deficits in subjects with post-ischemic stroke.

Description:

This was a randomized, placebo-controlled, three-arm, parallel-group study designed to evaluate the efficacy, safety, and tolerability of dalfampridine extended release (ER) tablets on chronic walking deficits in subjects with post-ischemic stroke.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical evidence of a stable walking deficit due to an ischemic stroke, as judged by the Investigator, based on review of medical records and physical exam. Such deficit was not present prior to the stroke and cannot be attributed primarily to other conditions (e.g. chronic obstructive pulmonary disease, arthritis). Evidence of walking deficits is objectively supported by any one of the following findings on clinical examination:

1. obvious slowness of movement assigned primarily to the stroke

2. use of an assistive walking device such as a cane or walker

3. Presence of movement pattern deviations such as stiff-legged gait, foot drop, hip hiking and hip circumduction

• Modified Rankin Scale score of 1 - 3, regardless of the cause(s) of the disability

• Sufficient ambulatory ability to independently complete the 2MinWT and 10MWT

• = 6 months from occurrence of most recent stroke

Exclusion Criteria:

• Woman who is not surgically sterile or is less than 2 years postmenopausal, and does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product.

• Woman who is pregnant, breastfeeding, or planning to become pregnant

• 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

• Suicide attempt within 1 year prior to the Screening Visit, or severe suicidal ideation within 6 months prior to the Screening Visit, or subject is at significant risk of suicidal behavior in the opinion of the Investigator

• Previous use of AMPYRA, dalfampridine, fampridine or 4-aminopyridine (4-AP)

• Initiation of a serotonin reuptake inhibitor (SSRI) within 3 months prior to the Screening Visit, or any change in dosing regimen within 3 months prior to the Screening Visit

• Botulinum toxin use within 2 months prior to the Screening Visit

• Orthopedic surgical procedures in any of the extremities within the past 6 months

Related Conditions & MeSH terms

• Post-Ischemic Stroke

Intervention

Drug:
• Placebo

• dalfampridine-ER 7.5mg

• dalfampridine-ER 10mg

Locations

Country	Name	City	State
Canada	Acorda Site #203	Fredericton	New Brunswick
Canada	Acorda Site #201	Greenfield Park	Quebec
Canada	Acorda Site #202	Halifax	Nova Scotia
Canada	Acorda Site #204	Montréal	Quebec
United States	Acorda Site #158	Abington	Pennsylvania
United States	Acorda Site #182	Alexandria	Virginia
United States	Acorda Site #186	Atlanta	Georgia
United States	Acorda Site #115	Atlantis	Florida
United States	Acorda Site #148	Avon	Indiana
United States	Acorda Site #187	Bellevue	Ohio
United States	Acorda Site #109	Berkeley	California
United States	Acorda Site #164	Bingham Farms	Michigan
United States	Acorda Site #121	Boston	Massachusetts
United States	Acorda Site #136	Boston	Massachusetts
United States	Acorda Site #166	Chapel Hill	North Carolina
United States	Acorda Site #171	Chicago	Illinois
United States	Acorda Site #160	Cleveland	Ohio
United States	Acorda Site #124	Colorado Springs	Colorado
United States	Acorda Site #137	Columbus	Ohio
United States	Acorda Site #152	Corvallis	Oregon
United States	Acorda Site #113	Dallas	Texas
United States	Acorda Site #165	Dallas	Texas
United States	Acorda Site #110	Danbury	Connecticut
United States	Acorda Site #116	Dayton	Ohio
United States	Acorda Site #119	Deerfield Beach	Florida
United States	Acorda Site #127	Detroit	Michigan
United States	Acorda Site #167	Durham	North Carolina
United States	Acorda Site #123	East Lansing	Michigan
United States	Acorda Site #149	Fairfield	Connecticut
United States	Acorda Site #188	Fort Wayne	Indiana
United States	Acorda Site #156	Franklin	Indiana
United States	Acorda Site #175	Fulton	Maryland
United States	Acorda Site #147	Gainesville	Florida
United States	Acorda Site #117	Gilbert	Arizona
United States	Acorda Site #159	Grand Rapids	Michigan
United States	Acorda Site #111	Great Falls	Montana
United States	Acorda Site #128	Hialeah	Florida
United States	Acorda Site #108	Houston	Texas
United States	Acorda Site #143	Jacksonville	Florida
United States	Acorda Site #181	Kailua	Hawaii
United States	Acorda Site #101	Kansas City	Missouri
United States	Acorda Site #146	Lexington	Kentucky
United States	Acorda Site #138	Long Beach	California
United States	Acorda Site #157	Memphis	Tennessee
United States	Acorda Site #103	Miami	Florida
United States	Acorda Site #133	Miami	Florida
United States	Acorda Site #162	Mooresville	North Carolina
United States	Acorda Site #161	Naples	Florida
United States	Acorda Site #131	New Brunswick	New Jersey
United States	Acorda Site #150	New Orleans	Louisiana
United States	Acorda Site #102	New York	New York
United States	Acorda Site #172	New York	New York
United States	Acorda Site #105	Newport Beach	California
United States	Acorda Site #170	Oceanside	California
United States	Acorda Site #142	Pasadena	California
United States	Acorda Site #179	Patchogue	New York
United States	Acorda Site #122	Philadelphia	Pennsylvania
United States	Acorda Site #126	Portland	Oregon
United States	Acorda Site #168	Portland	Oregon
United States	Acorda Site #144	Providence	Rhode Island
United States	Acorda Site #154	Raleigh	North Carolina
United States	Acorda Site #140	Reno	Nevada
United States	Acorda Site #176	Richmond	Virginia
United States	Acorda Site #153	Sacramento	California
United States	Acorda Site #151	San Diego	California
United States	Acorda Site #163	San Diego	California
United States	Acorda Site #107	Spokane	Washington
United States	Acorda Site #130	Stamford	Connecticut
United States	Acorda Site #177	Stratford	New Jersey
United States	Acorda Site #145	Sunrise	Florida
United States	Acorda Site #106	Tampa	Florida
United States	Acorda Site #114	White Plains	New York
United States	Acorda Site #132	Winston-Salem	North Carolina
United States	Acorda Site #120	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Who Show at Least a 20% Improvement on the Two Minute Walk Test (2MinWT) at Week 12	"The 2MinWT measures the distance a subject can walk in 2 minutes. Participants showing at Least a 20% Improvement on the 2MinWT at 12-weeks are considered "Responders".	Week 12
Secondary	Change From Baseline on the Walking Impact Scale (Walk-12) at Week 12 (Key Secondary)	The Walk-12 is a 12-question questionnaire that asks subjects to rate limitations of their mobility during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). For each visit, the Walk-12 score will be calculated by summing the 12 components and transforming into a scale with a range of 0 to 100. A higher score indicates a greater degree of limitation in walking. A negative change indicates an improvement in walking. 0 = no limitation in mobility to 100 extreme limitation in mobility.; Walk-12 Score = 100 * [(Mean of the 12 items) - 1]/(5-1)	Baseline, week 12

External Links

•   Click here for potential enrollment or for more information about this study: DALF-PS-1016