Trials Sponsors Conditions Drugs Pricing

Conditions

Post-Ischemic Stroke

Keywords

Post strokeIschemic 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.

Interventions

PlaceboDrug

Placebo

dalfampridine-ER 7.5mgDrug

dalfampridine-ER 7.5 mg

dalfampridine-ER 10mg

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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:

Sponsors & Collaborators

Acorda Therapeutics
Industrylead

Study Sites (74)

Acorda Site #117

Gilbert, Arizona, 85234, United States

Acorda Site #109

Berkeley, California, 94705, United States

Acorda Site #138

Long Beach, California, 90806, United States

Acorda Site #105

Newport Beach, California, 92663, United States

Acorda Site #170

Oceanside, California, 92056, United States

Acorda Site #142

Pasadena, California, 91105, United States

Acorda Site #153

Sacramento, California, 95823, United States

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: 32651338DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

4-Aminopyridine

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AminopyridinesAminesOrganic ChemicalsPyridines

Results Point of Contact

Title: Holly Roberts, Executive Medical Director
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

377 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

October 20, 2014

First Posted

October 22, 2014

Study Start

December 2014

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

Placebo

dalfampridine-ER 7.5 mg

dalfampridine-ER 10mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (74)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

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