Clinical trial NCT02271217: A Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Ischemic Stroke
Keywords: Post stroke
Ischemic stroke
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-10-22
Enrollment: 377
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Subjects Who Show at Least a 20% Improvement on the Two Minute Walk Test (2MinWT) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline on the Walking Impact Scale (Walk-12) at Week 12 (Key Secondary)
timeFrame: Baseline, week 12
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Acorda Site #117
state: Arizona
city: Berkeley
country: United States
facility: Acorda Site #109
state: California
city: Long Beach
country: United States
facility: Acorda Site #138
state: California
city: Newport Beach
country: United States
facility: Acorda Site #105
state: California
city: Oceanside
country: United States
facility: Acorda Site #170
state: California
city: Pasadena
country: United States
facility: Acorda Site #142
state: California
city: Sacramento
country: United States
facility: Acorda Site #153
state: California
city: San Diego
country: United States
facility: Acorda Site #151
state: California
city: San Diego
country: United States
facility: Acorda Site #163
state: California
city: Colorado Springs
country: United States
facility: Acorda Site #124
state: Colorado
city: Danbury
country: United States
facility: Acorda Site #110
state: Connecticut
city: Fairfield
country: United States
facility: Acorda Site #149
state: Connecticut
city: Stamford
country: United States
facility: Acorda Site #130
state: Connecticut
city: Atlantis
country: United States
facility: Acorda Site #115
state: Florida
city: Deerfield Beach
country: United States
facility: Acorda Site #119
state: Florida
city: Gainesville
country: United States
facility: Acorda Site #147
state: Florida
city: Hialeah
country: United States
facility: Acorda Site #128
state: Florida
city: Jacksonville
country: United States
facility: Acorda Site #143
state: Florida
city: Miami
country: United States
facility: Acorda Site #103
state: Florida
city: Miami
country: United States
facility: Acorda Site #133
state: Florida
city: Naples
country: United States
facility: Acorda Site #161
state: Florida
city: Sunrise
country: United States
facility: Acorda Site #145
state: Florida
city: Tampa
country: United States
facility: Acorda Site #106
state: Florida
city: Atlanta
country: United States
facility: Acorda Site #186
state: Georgia
city: Kailua
country: United States
facility: Acorda Site #181
state: Hawaii
city: Chicago
country: United States
facility: Acorda Site #171
state: Illinois
city: Avon
country: United States
facility: Acorda Site #148
state: Indiana
city: Fort Wayne
country: United States
facility: Acorda Site #188
state: Indiana
city: Franklin
country: United States
facility: Acorda Site #156
state: Indiana
city: Lexington
country: United States
facility: Acorda Site #146
state: Kentucky
city: New Orleans
country: United States
facility: Acorda Site #150
state: Louisiana
city: Fulton
country: United States
facility: Acorda Site #175
state: Maryland
city: Boston
country: United States
facility: Acorda Site #136
state: Massachusetts
city: Boston
country: United States
facility: Acorda Site #121
state: Massachusetts
city: Worcester
country: United States
facility: Acorda Site #120
state: Massachusetts
city: Bingham Farms
country: United States
facility: Acorda Site #164
state: Michigan
city: Detroit
country: United States
facility: Acorda Site #127
state: Michigan
city: East Lansing
country: United States
facility: Acorda Site #123
state: Michigan
city: Grand Rapids
country: United States
facility: Acorda Site #159
state: Michigan
city: Kansas City
country: United States
facility: Acorda Site #101
state: Missouri
city: Great Falls
country: United States
facility: Acorda Site #111
state: Montana
city: Reno
country: United States
facility: Acorda Site #140
state: Nevada
city: New Brunswick
country: United States
facility: Acorda Site #131
state: New Jersey
city: Stratford
country: United States
facility: Acorda Site #177
state: New Jersey
city: New York
country: United States
facility: Acorda Site #172
state: New York
city: New York
country: United States
facility: Acorda Site #102
state: New York
city: Patchogue
country: United States
facility: Acorda Site #179
state: New York
city: White Plains
country: United States
facility: Acorda Site #114
state: New York
city: Chapel Hill
country: United States
facility: Acorda Site #166
state: North Carolina
city: Durham
country: United States
facility: Acorda Site #167
state: North Carolina
city: Mooresville
country: United States
facility: Acorda Site #162
state: North Carolina
city: Raleigh
country: United States
facility: Acorda Site #154
state: North Carolina
city: Winston-Salem
country: United States
facility: Acorda Site #132
state: North Carolina
city: Bellevue
country: United States
facility: Acorda Site #187
state: Ohio
city: Cleveland
country: United States
facility: Acorda Site #160
state: Ohio
city: Columbus
country: United States
facility: Acorda Site #137
state: Ohio
city: Dayton
country: United States
facility: Acorda Site #116
state: Ohio
city: Corvallis
country: United States
facility: Acorda Site #152
state: Oregon
city: Portland
country: United States
facility: Acorda Site #168
state: Oregon
city: Portland
country: United States
facility: Acorda Site #126
state: Oregon
city: Abington
country: United States
facility: Acorda Site #158
state: Pennsylvania
city: Philadelphia
country: United States
facility: Acorda Site #122
state: Pennsylvania
city: Providence
country: United States
facility: Acorda Site #144
state: Rhode Island
city: Memphis
country: United States
facility: Acorda Site #157
state: Tennessee
city: Dallas
country: United States
facility: Acorda Site #113
state: Texas
city: Dallas
country: United States
facility: Acorda Site #165
state: Texas
city: Houston
country: United States
facility: Acorda Site #108
state: Texas
city: Alexandria
country: United States
facility: Acorda Site #182
state: Virginia
city: Richmond
country: United States
facility: Acorda Site #176
state: Virginia
city: Spokane
country: United States
facility: Acorda Site #107
state: Washington
city: Fredericton
country: Canada
facility: Acorda Site #203
state: New Brunswick
city: Halifax
country: Canada
facility: Acorda Site #202
state: Nova Scotia
city: Greenfield Park
country: Canada
facility: Acorda Site #201
state: Quebec
city: Montréal
country: Canada
facility: Acorda Site #204
state: Quebec
Study officials:
affiliation: Acorda Therapeutics
name: Holly Roberts, MD
role: STUDY_DIRECTOR
References:
citation: Page SJ, Kasner SE, Bockbrader M, Goldstein M, Finklestein SP, Ning M, El-Feky WH, Wilson CA, Roberts H; all of the investigators involved in the MILESTONE study. A double-blind, randomized, controlled study of two dose strengths of dalfampridine extended release on walking deficits in ischemic stroke. Restor Neurol Neurosci. 2020;38(4):301-309. doi: 10.3233/RNN-201009.