Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine.

NCT02422940 | Terminated Phase 3 Results DMC

• 1 other identifier: DALF-PS-1029
• Study Type: interventional
• Target: 294
• Locations: 2 countries
• Sites: 66

Brief Summary

This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER.

Conditions

Post-ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• The Primary Objective Was to Evaluate Serious and Non-serious Adverse Events for Study Participants as a Measure of Safety and Tolerability of Dalfampridine ER (Extended Release) for at Least 12-months.

  This extension study was designed to evaluate long-term safety, tolerability, and efficacy of dalfampridine-ER (extended release) in adult subjects with chronic post-ischemic stroke walking deficits. Subjects who had completed the placebo-controlled DALF-PS-1016 core study were eligible to enroll regardless of whether they had received active drug or placebo in the core study.

  up to 12 months

Secondary Outcomes (7)

• Change From Baseline on the Two-Minute Walk Test (2MinWT)

  Day 1, up to 12 months

• Change From Baseline on the 10 Meter Walk Test (10MWT)

  Day 1, up to 12 months

• Change From Baseline on the Timed up and Go (TUG) Test

  Day 1, up to 12 months

• Change From Baseline on the Walking Impact Scale (Walk-12)

  Day 1, up to 12 months

• Change From Baseline on the Stroke Impact Scale (SIS)

  Day 1, up to 12 months

Study Arms (2)

dalfampridine-ER 7.5 mg

ACTIVE COMPARATOR

Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.

Drug: dalfampridine-ER 7.5 mg

dalfampridine-ER 10 mg

ACTIVE COMPARATOR

Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.

Drug: dalfampridine-ER 10 mg

Interventions

dalfampridine-ER 7.5 mg DRUG

dalfampridine-ER 7.5 mg

dalfampridine-ER 10 mg DRUG

Also known as: Ampyra™

dalfampridine-ER 10 mg

Eligibility Criteria

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

You may qualify if:

• Completion of the DALF-PS-1016 study
• Providing informed consent to continue into the DALF-PS-1029 long-term extension study
• Sufficient ambulatory ability to independently complete the Two Minute Walk Test (2MinWT) and 10 Meter Walk Test (10MWT) at the time of enrollment into the extension study

You may not qualify if:

• Seizures, new onset strokes (or other significant neurological event precluding long-term continuation) occurring during the antecedent DALF-PS-1016 study
• Calculated creatinine clearance of ≤ 50 mL/minute at the time of enrollment into the long-term extension study

Sponsors & Collaborators

• Acorda Therapeutics: lead

Study Sites (66)

Acorda Site #117

Gilbert, Arizona, 85234, United States

Location

Acorda Site #109

Berkeley, California, 94705, United States

Location

Acorda Site #170

Carlsbad, California, 92011, 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 #142

Pasadena, California, 91105, United States

Location

Acorda Site #153

Sacramento, California, 95823, United States

Location

Acorda Site #151

San Diego, California, 921018466, 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, 33441, United States

Location

Acorda Site #147

Gainesville, Florida, 326100236, United States

Location

Acorda Site #128

Hialeah, Florida, 33012, United States

Location

Acorda Site #184

Jacksonville, Florida, 32277, 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 #106

Tampa, Florida, 33606, United States

Location

Acorda Site #181

Honolulu, Hawaii, 96817, 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, 46804, 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 #123

East Lansing, Michigan, 48824, United States

Location

Acorda Site #164

Farmington Hills, Michigan, 48334, 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, 08901, 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 #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, 27710, 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 #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 #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

Falls Church, Virginia, 22043, 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, J4V2H1, Canada

Location

Acorda Site #204

Montreal, Quebec, H3G1A4, Canada

Location

MeSH Terms

Interventions

4-Aminopyridine

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Holy Roberts, Executive Medical Director - Medical Affairs
• Organization: Acorda Therapeutics

hroberts@acorda.com

914-326-5224

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: April 14, 2015
• First Posted: April 22, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 22, 2019
• Results First Posted: August 8, 2018

Record last verified: 2018-08

Locations

US (62); CA (4)