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

NCT02271217 | Completed Phase 3 Results DMC

• 1 other identifier: DALF-PS-1016
• Study Type: interventional
• Target: 377
• Locations: 2 countries
• Sites: 74

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.

Conditions

Post-Ischemic Stroke

Keywords

Post stroke; Ischemic stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline on the Walking Impact Scale (Walk-12) at Week 12 (Key Secondary)

  Baseline, week 12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.

Drug: Placebo

dalfampridine-ER 7.5 mg

ACTIVE COMPARATOR

Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.

Drug: dalfampridine-ER 7.5mg

dalfampridine-ER 10mg

ACTIVE COMPARATOR

Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.

Drug: dalfampridine-ER 10mg

Interventions

Placebo DRUG

Placebo

dalfampridine-ER 7.5mg DRUG

dalfampridine-ER 7.5 mg

dalfampridine-ER 10mg DRUG

Also known as: Ampyra

dalfampridine-ER 10mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• obvious slowness of movement assigned primarily to the stroke
• use of an assistive walking device such as a cane or walker
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acorda Therapeutics: lead

Study Sites (74)

Acorda Site #117

Gilbert, Arizona, 85234, United States

Location

Acorda Site #109

Berkeley, California, 94705, United States

Location

Acorda Site #138

Long Beach, California, 90806, United States

Location

Acorda Site #105

Newport Beach, California, 92663, United States

Location

Acorda Site #170

Oceanside, California, 92056, United States

Location

Acorda Site #142

Pasadena, California, 91105, United States

Location

Acorda Site #153

Sacramento, California, 95823, United States

Location

Acorda Site #151

San Diego, California, 92103, United States

Location

Acorda Site #163

San Diego, California, 92123, United States

Location

Acorda Site #124

Colorado Springs, Colorado, 80907, United States

Location

Acorda Site #110

Danbury, Connecticut, 06810, United States

Location

Acorda Site #149

Fairfield, Connecticut, 06824, United States

Location

Acorda Site #130

Stamford, Connecticut, 06905, United States

Location

Acorda Site #115

Atlantis, Florida, 33462, United States

Location

Acorda Site #119

Deerfield Beach, Florida, 33064, United States

Location

Acorda Site #147

Gainesville, Florida, 32611, United States

Location

Acorda Site #128

Hialeah, Florida, 33012, United States

Location

Acorda Site #143

Jacksonville, Florida, 32209, United States

Location

Acorda Site #103

Miami, Florida, 33142, United States

Location

Acorda Site #133

Miami, Florida, 33175, United States

Location

Acorda Site #161

Naples, Florida, 34102, United States

Location

Acorda Site #145

Sunrise, Florida, 33351, United States

Location

Acorda Site #106

Tampa, Florida, 33606, United States

Location

Acorda Site #186

Atlanta, Georgia, 30309, United States

Location

Acorda Site #181

Kailua, Hawaii, 96734, United States

Location

Acorda Site #171

Chicago, Illinois, 60611, United States

Location

Acorda Site #148

Avon, Indiana, 46123, United States

Location

Acorda Site #188

Fort Wayne, Indiana, 46805, United States

Location

Acorda Site #156

Franklin, Indiana, 46131, United States

Location

Acorda Site #146

Lexington, Kentucky, 40513, United States

Location

Acorda Site #150

New Orleans, Louisiana, 70121, United States

Location

Acorda Site #175

Fulton, Maryland, 20759, United States

Location

Acorda Site #136

Boston, Massachusetts, 02114, United States

Location

Acorda Site #121

Boston, Massachusetts, 02118, United States

Location

Acorda Site #120

Worcester, Massachusetts, 016052610, United States

Location

Acorda Site #164

Bingham Farms, Michigan, 48025, United States

Location

Acorda Site #127

Detroit, Michigan, 48201, United States

Location

Acorda Site #123

East Lansing, Michigan, 48824, United States

Location

Acorda Site #159

Grand Rapids, Michigan, 49503, United States

Location

Acorda Site #101

Kansas City, Missouri, 64132, United States

Location

Acorda Site #111

Great Falls, Montana, 59405, United States

Location

Acorda Site #140

Reno, Nevada, 89502, United States

Location

Acorda Site #131

New Brunswick, New Jersey, 08903, United States

Location

Acorda Site #177

Stratford, New Jersey, 08084, United States

Location

Acorda Site #172

New York, New York, 10029, United States

Location

Acorda Site #102

New York, New York, 11220, United States

Location

Acorda Site #179

Patchogue, New York, 11772, United States

Location

Acorda Site #114

White Plains, New York, 10605, United States

Location

Acorda Site #166

Chapel Hill, North Carolina, 27599, United States

Location

Acorda Site #167

Durham, North Carolina, 27705, United States

Location

Acorda Site #162

Mooresville, North Carolina, 28117, United States

Location

Acorda Site #154

Raleigh, North Carolina, 276076010, United States

Location

Acorda Site #132

Winston-Salem, North Carolina, 27103, United States

Location

Acorda Site #187

Bellevue, Ohio, 44811, United States

Location

Acorda Site #160

Cleveland, Ohio, 44195, United States

Location

Acorda Site #137

Columbus, Ohio, 43210, United States

Location

Acorda Site #116

Dayton, Ohio, 45417, United States

Location

Acorda Site #152

Corvallis, Oregon, 97330, United States

Location

Acorda Site #168

Portland, Oregon, 97225, United States

Location

Acorda Site #126

Portland, Oregon, 97239, United States

Location

Acorda Site #158

Abington, Pennsylvania, 19001, United States

Location

Acorda Site #122

Philadelphia, Pennsylvania, 19104, United States

Location

Acorda Site #144

Providence, Rhode Island, 02903, United States

Location

Acorda Site #157

Memphis, Tennessee, 38163, United States

Location

Acorda Site #113

Dallas, Texas, 75214, United States

Location

Acorda Site #165

Dallas, Texas, 75246, United States

Location

Acorda Site #108

Houston, Texas, 77030, United States

Location

Acorda Site #182

Alexandria, Virginia, 22310, United States

Location

Acorda Site #176

Richmond, Virginia, 23298, United States

Location

Acorda Site #107

Spokane, Washington, 992021330, United States

Location

Acorda Site #203

Fredericton, New Brunswick, E3B0C7, Canada

Location

Acorda Site #202

Halifax, Nova Scotia, B3H4K4, Canada

Location

Acorda Site #201

Greenfield Park, Quebec, J4V2G9, Canada

Location

Acorda Site #204

Montreal, Quebec, H3G1A4, Canada

Location

Related Publications (1)

• 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.

  PMID: 32651338 DERIVED

Related Links

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

MeSH Terms

Conditions

Ischemic Stroke

Interventions

4-Aminopyridine

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Holly Roberts, Executive Medical Director
• Organization: Acorda Therapeutics

hroberts@acorda.com

914-326-5000

Study Officials

• Holly Roberts, MD

  Acorda Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 22, 2014
• Study Start: December 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 7, 2018
• Results First Posted: December 4, 2017

Record last verified: 2017-09

Locations

CA (4); US (70)