NCT02422940 (MILESTONE℠) is a Phase 3 clinical trial of dalfampridine-ER 7.5 mg in Post-ischemic Stroke, sponsored by Acorda Therapeutics.

Who is sponsoring NCT02422940?

NCT02422940 is sponsored by Acorda Therapeutics.

What drugs are being tested in NCT02422940?

Interventions in NCT02422940: dalfampridine-ER 7.5 mg, dalfampridine-ER 10 mg.

What condition does NCT02422940 study?

NCT02422940 studies Post-ischemic Stroke.

Is NCT02422940 still recruiting?

NCT02422940 is currently terminated. Last updated 17 January 2019.

Are results published for NCT02422940?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-01-17 · How we verify

NCT02422940: MILESTONE℠

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Extension Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine Extended-Release Tablets. for the Treatment of Chronic Post-Ischemic Stroke Walking Deficits .

Terminated Phase 3 Results posted Last updated 17 January 2019

What this trial tests

Phase 3 trial testing dalfampridine-ER 7.5 mg in Post-ischemic Stroke in 294 participants. Terminated before completion.

Timeline

1 April 2015

Primary endpoint
1 January 2017

1 January 2017

Quick facts

Lead sponsor	Acorda Therapeutics
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	294
Start date	1 April 2015
Primary completion	1 January 2017
Estimated completion	1 January 2017
Sites	66 locations across United States, Canada

Drugs / interventions tested

dalfampridine-ER 7.5 mg — full drug profile →
dalfampridine-ER 10 mg — full drug profile →

Conditions studied

Post-ischemic Stroke — all drugs for Post-ischemic Stroke →

Sponsor

Acorda Therapeutics — full company profile →

Who can join

18 and older, any sex, with Post-ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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.
Time frame: up to 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.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other Acorda Therapeutics trials

Trials by the same sponsor.

NCT03887884 — Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02422940 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Acorda Therapeutics
Last refreshed: 17 January 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02422940.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing