Trials Sponsors Conditions Drugs Pricing

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
+2 more secondary outcomes

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 mgDrug

dalfampridine-ER 7.5 mg

dalfampridine-ER 10 mgDrug

Also known as: Ampyra™

dalfampridine-ER 10 mg

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Acorda Therapeutics
Industrylead

Study Sites (66)

Acorda Site #117

Gilbert, Arizona, 85234, United States

Acorda Site #109

Berkeley, California, 94705, United States

Acorda Site #170

Carlsbad, California, 92011, United States

Acorda Site #138

Long Beach, California, 90806, United States

Acorda Site #105

Newport Beach, California, 92663, United States

Acorda Site #142

Pasadena, California, 91105, United States

Acorda Site #153

Sacramento, California, 95823, United States

MeSH Terms

Interventions

4-Aminopyridine

Intervention Hierarchy (Ancestors)

AminopyridinesAminesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

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

Study Officials

Holly Roberts, MD
Acorda Therapeutics
STUDY DIRECTOR

Publication Agreements

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

Enrollment

294 participants (actual enrollment reported by the registry).

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 2015

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

dalfampridine-ER 7.5 mg

dalfampridine-ER 10 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (66)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

dalfampridine-ER 7.5 mg

dalfampridine-ER 10 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (66)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations