Evidence map›Paper›PMID 32651338›Full record

Trial reportRestorative neurology and neuroscience2020

A double-blind, randomized, controlled study of two dose strengths of dalfampridine extended release on walking deficits in ischemic stroke.

Stephen J Page, Scott E Kasner, Marcia Bockbrader, Mark Goldstein, Seth P Finklestein, MingMing Ning, Waleed H El-Feky, Christina A Wilson, Holly Roberts, all of the investigators involved in the MILESTONE study

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Restorative neurology and neuroscience, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02271217 (This is a Multi-center, Double-blind, Three Arm, Parallel Group, Placebo-controlled, Randomized Study Designed to Evaluate the Efficacy, Safety and Tolerability of Dalfampridine.), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact, top 90% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02271217 phase3completednot on this map

This is a Multi-center, Double-blind, Three Arm, Parallel Group, Placebo-controlled, Randomized Study Designed to Evaluate the Efficacy, Safety and Tolerability of Dalfampridine.

TypeinterventionalSponsorAcorda TherapeuticsRan2014 to 2016Enrolled377ConditionsPost-Ischemic StrokeArmsPlacebo, dalfampridine-ER 7.5mg, dalfampridine-ER 10mg
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Exploring the use of dalfampridine (4-aminopyridine) for treatment of ataxia in cerebellar stroke.PM & R : the journal of injury, function, and rehabilitation · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 1 country.

Stephen J PageRehabLab™, Neurorecovery Unlimited, LLC, Columbus, OH, USA.
Scott E KasnerUniversity of Pennsylvania, Philadelphia, PA, USA.
Marcia BockbraderOhio State University Medical Center, Columbus, OH, USA.
Mark GoldsteinJEM Research Institute, Atlantis, FL, USA.
Seth P FinklesteinMassachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
MingMing NingMassachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Waleed H El-FekyTexas Neurology, Dallas, TX, USA.
Christina A WilsonUniversity of Florida, Gainesville, FL, USA.
Holly RobertsAcorda Therapeutics, Inc., Ardsley, NY, USA.
all of the investigators involved in the MILESTONE study
Harvard University · USAcorda Therapeutics (United States) · USJEM Research Institute · USTexas Neurology · USThe Ohio State University Wexner Medical Center · USUniversity of Florida · USUniversity of Pennsylvania · US

Funding

Proteomic Profiling of Patent Foramen Ovale Related Neurovascular InjuryR01NS067139 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI NING, MINGMING · 2010 to 2023
$3.7M
Thrombolysis Profiles in tPA ResponseR01NS093415 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI LO, ENG H., NING, MINGMING · 2015 to 2019
$1.9M
Glycoproteomics in Ischemic Stroke Related HyperglycemiaR21NS113065 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI NING, MINGMING · 2020 to 2020
$462k
NINDS NIH HHS R01 NS067139NINDS NIH HHS R01 NS093415NINDS NIH HHS R21 NS113065
6 · The paper itself

Abstract

backgroundStroke-induced ischemia affects both cortex and underlying white matter. Dalfampridine extended release tablets (D-ER) enhance action potential conduction in demyelinated axons, which may positively affect post-stroke recovery.

objectiveBased on promising preliminary data, we compared efficacy of D-ER administered at 7.5 mg or 10 mg with placebo on post-stroke ambulation. Primary study outcome (response) was a ≥20% increase on the 2-minute walk test (2 MinWT) at 12 weeks after first drug administration.

methodsThis was a multicenter, randomized, placebo-controlled, 3-arm, parallel-group, safety and efficacy trial. After obtaining baseline measures of 2 MinWT, Walk-12, and Timed Up and Go, subjects entered a 2-week, single-blind placebo run-in period and were randomized 1:1:1 to receive 7.5 mg D-ER, 10 mg D-ER, or placebo, dosed twice-daily for 12 weeks. Follow-up evaluations occurred at weeks 14 and 16 when subjects were off study drug.

resultsThe study was terminated early with 377 of planned 540 patients enrolled, due to no treatment effect. At week 12, mean increase in distances walked in 2 minutes were similar among the 3 study groups (14.9±40.0 feet; 19.4±39.6 feet; and 20.4±38.3 feet for placebo, 7.5 mg D-ER, and 10 mg D-ER, respectively). The proportion of subjects who showed ≥20% improvement on 2 MinWT at week 12 was 13.5%, 14.0%, and 19.0%, for placebo, 7.5 mg D-ER, and 10 mg D-ER, respectively; these were nonsignificant changes from baseline for all groups.

conclusionsD-ER at either a 7.5-mg or 10-mg dose did not significantly increase performance on the 2 MinWT in stroke survivors with gait impairment, although this study was terminated early before full enrollment. (Clinical Trial # NCT02271217).

Indexed as

4-AminopyridineAdultBrain IschemiaDelayed-Action PreparationsDouble-Blind MethodHumansIschemic StrokeMaleMiddle AgedMultiple SclerosisOutcome Assessment, Health CareWalking4-AminopyridineDelayed-Action Preparationsambulationhemiplegialower extremityrehabilitationstroke

Identifiers

PMID32651338
PMCPMC7592666
OpenAlexW3041665230

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.