NCT01605825 is a Phase 2 clinical trial of placebo/dalfampridine-ER in Ischemic Stroke, sponsored by Acorda Therapeutics.

Who is sponsoring NCT01605825?

NCT01605825 is sponsored by Acorda Therapeutics.

What drugs are being tested in NCT01605825?

Interventions in NCT01605825: placebo/dalfampridine-ER, dalfampridine-ER/placebo.

What condition does NCT01605825 study?

NCT01605825 studies Ischemic Stroke.

Is NCT01605825 still recruiting?

NCT01605825 is currently completed. Last updated 18 December 2015.

Are results published for NCT01605825?

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

Last reviewed 2015-12-18 · How we verify

NCT01605825

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

A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke

Completed Phase 2 Results posted Last updated 18 December 2015

What this trial tests

Phase 2 trial testing placebo/dalfampridine-ER in Ischemic Stroke in 83 participants. Completed in 1 March 2013.

Timeline

1 May 2012

Primary endpoint
1 February 2013

1 March 2013

Quick facts

Lead sponsor	Acorda Therapeutics
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	83
Start date	1 May 2012
Primary completion	1 February 2013
Estimated completion	1 March 2013
Sites	20 locations across United States

Drugs / interventions tested

placebo/dalfampridine-ER — full drug profile →
dalfampridine-ER/placebo — full drug profile →

Conditions studied

Ischemic Stroke — all drugs for Ischemic Stroke →

Sponsor

Acorda Therapeutics — full company profile →

Who can join

Adults 18 to 85, any sex, with 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.

Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: up to 36 days
A TEAE is defined as any adverse event with date of onset (or worsening) on or after the start-date of double-blind treatment through 7 days after the last dose of double-blind treatment. The severity categories of mild, moderate or severe, are defined below: * Mild is defined as causing no limitation of usual activities * Moderate is defined as causing some limitation of usual activities * Seve

Sponsor's own description

This is a multi-center, safety and tolerability study in subjects with chronic stable sensorimotor deficits after ischemic stroke. It has been designed as a double-blind, placebo-controlled, 2-period crossover study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Dalfampridine improves sensorimotor function in rats with chronic deficits after middle cerebral artery occlusion.
Iaci JF, Parry TJ, Huang Z, Finklestein SP, et al · · 2013 · cited 13× · PMID 23652269 · DOI 10.1161/strokeaha.111.000147

Verify or expand the search:

Other recruiting trials for Ischemic Stroke

Currently open trials in the same condition.

NCT07509645 — Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Post · Phase 3 · recruiting
NCT07375953 — Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK) · Phase 2 · recruiting
NCT07375966 — Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours · Phase 2 · recruiting
NCT07491952 — Continuous Dual Aspiration Technique With Zoom System for Stroke · recruiting
NCT07371455 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants · Phase 1 · recruiting

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 NCT01605825 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 18 December 2015

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/NCT01605825.

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