Last reviewed · How we verify
NCT02271217: MILESTONE℠
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.
Phase 3 trial testing Placebo in Post-Ischemic Stroke in 377 participants. Completed in 1 October 2016.
1 September 2016
Quick facts
| Lead sponsor | Acorda Therapeutics |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 377 |
| Start date | 1 December 2014 |
| Primary completion | 1 September 2016 |
| Estimated completion | 1 October 2016 |
| Sites | 74 locations across United States, Canada |
Drugs / interventions tested
- Placebo
- dalfampridine-ER 7.5mg — full drug profile →
- dalfampridine-ER 10mg — 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.
-
Proportion of Subjects Who Show at Least a 20% Improvement on the Two Minute Walk Test (2MinWT) at Week 12
Time frame: 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".
Sponsor's own description
The objective of this study is to determine the effect of two dose strengths of dalfampridine-Extended Release (ER) tablets, taken twice daily for 12 weeks, on stable walking deficits in subjects with post-ischemic stroke.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A double-blind, randomized, controlled study of two dose strengths of dalfampridine extended release on walking deficits in ischemic stroke.
Page SJ, Kasner SE, Bockbrader M, Goldstein M, et al · · 2020 · cited 1× · PMID 32651338 · DOI 10.3233/rnn-201009
Verify or expand the search:
- PubMed search for NCT02271217
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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)
- Trial protocol + status: ClinicalTrials.gov NCT02271217 (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: 4 June 2018
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/NCT02271217.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing