Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2015
Long-term safety and efficacy of dalfampridine for walking impairment in patients with multiple sclerosis: Results of open-label extensions of two Phase 3 clinical trials.
Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02849782 (Short and Long Term Fampridine Treatment in Persons With Multiple Sclerosis), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled 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.
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.
Short and Long Term Fampridine Treatment in Persons With Multiple Sclerosis: Cognitive and Motor Performances
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.
- Functional improvement in individuals with chronic spinal cord injury treated with 4-aminopyridine: A systematic review.Frontiers in neurology · 2022Pooled it
- Long-term safety and efficacy of daclizumab beta in relapsing-remitting multiple sclerosis: 6-year results from the SELECTED open-label extension study.Journal of neurology · 2020Trial
- Trial
- Positive effects of fampridine on cognition, fatigue and depression in patients with multiple sclerosis over 2 years.Journal of neurology · 2018Trial
- Safety and efficacy of daclizumab in relapsing-remitting multiple sclerosis: 3-year results from the SELECTED open-label extension study.BMC neurology · 2016Trial
- Exploring the use of dalfampridine (4-aminopyridine) for treatment of ataxia in cerebellar stroke.PM & R : the journal of injury, function, and rehabilitation · 2026Article
- Activation of Kir4.1 Channels by 2-D08 Promotes Myelin Repair in Multiple Sclerosis.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Article
- Investigating the Safety of Fampridine in Patients with Different Stages of Multiple Sclerosis.International journal of preventive medicine · 2025Article
- Article
- Neuro-orthopaedic check-up and walking in people with multiple sclerosis: toward a more specific assessment to improve rehabilitation results.Journal of exercise rehabilitation · 2024Article
- Efficacy of prolonged-release fampridineTherapeutic advances in neurological disorders · 2022Article
- Observational
- Neuroprotective Properties of 4-Aminopyridine.Neurology(R) neuroimmunology & neuroinflammation · 2021Review
- Clinical, Neurophysiological, and MRI Markers of Fampridine Responsiveness in Multiple Sclerosis-An Explorative Study.Frontiers in neurology · 2021Article
- Restoring Axonal Function with 4-Aminopyridine: Clinical Efficacy in Multiple Sclerosis and Beyond.CNS drugs · 2018Review
- Impact of fampridine on quality of life: clinical benefit in real-world practice.European journal of hospital pharmacy : science and practice · 2018Article
- Prolonged-release fampridine in multiple sclerosis: clinical data and real-world experience. Report of an expert meeting.Therapeutic advances in neurological disorders · 2018Review
- Fampridine Prolonged Release: A Review in Multiple Sclerosis Patients with Walking Disability.Drugs · 2017Review
- Inpatient Admissions and Costs Associated with Persistent Use of Dalfampridine Extended-Release in Multiple Sclerosis: A Claims Database Analysis.Journal of managed care & specialty pharmacy · 2017Observational
- Fatigue Management in Multiple Sclerosis.Current treatment options in neurology · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn Phase 3 double-blind trials (MS-F203 and MS-F204), dalfampridine extended release tablets 10 mg twice daily (dalfampridine-ER; prolonged-release fampridine in Europe; fampridine modified or sustained release elsewhere) improved walking speed relative to placebo in patients with multiple sclerosis (MS).
objectivesEvaluation of long-term safety and efficacy of dalfampridine-ER in open-label extensions (MS-F203EXT, MS-F204EXT).
methodsPatients received dalfampridine-ER 10 mg twice daily; and had Timed 25-Foot Walk (T25FW) assessments at 2, 14 and 26 weeks, and then every 6 months. Subjects were categorized as dalfampridine-ER responders or non-responders, based on their treatment response in the double-blind parent trials that assessed T25FW.
resultsWe had 269 patients enter MS-F203EXT and 154 patients complete it; for a maximum exposure of 5 years. We had 214 patients enter MS-F204EXT and 146 complete it; for a maximum exposure of 3.3 years. No new safety signals emerged and dalfampridine-ER tolerability was consistent with the double-blind phase. Improvements in walking speed were lost after dalfampridine-ER was discontinued in the parent trial, but returned by the 2-week assessment after re-initiation of the drug. Throughout the extensions, mean improvement in walking speed declined, but remained improved, among the double-blind responders as compared with non-responders.
conclusionsThe dalfamipridine-ER safety profile was consistent with the parent trials. Although walking speed decreased over time, dalfampridine-ER responders continued to show improved walking speed, which was sustained compared with non-responders.
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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 OpenQuestion graph.