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Use of Dalfampridine in Primary Lateral Sclerosis
NCT02868567 · View on ClinicalTrials.gov ↗
Study Summary
This study will comprise an 18-week open label safety and tolerability trial. In this study, a total of 35 subjects with primary lateral sclerosis PLS or upper motor neuron predominate ALS will be enrolled. At the initial screening evaluation, a baseline T25FW will be obtained. This baseline test will be repeated at weeks 2, 4, 6, 10, 14 18. The validity of this measure was shown in MS studies when compared to the MSWS-12 (12 item walking scale) and CGI (clinical global impression) scales (35-37). A consistent responder will be defined as improvement in 3 of 4 Timed 25Foot Walk while on medication, compared with the baseline results while off medication.
Conditions Studied
Interventions
- DRUG dalfampridine
Study Locations (3)
Florida
- University of Florida Gainsville — Gainesville
Massachusetts
- Mass General Hospital — Boston
New York
- Shara Holzberg — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2016-03 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02868567
The ClinicalTrials.gov registry entry for NCT02868567 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 141 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Motor Neuron Disease, Upper appearing as the primary indexed condition, and to 1 intervention — of which dalfampridine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02868567 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Florida, Massachusetts, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02868567 about?
NCT02868567 is a clinical study titled "Use of Dalfampridine in Primary Lateral Sclerosis". This study will comprise an 18-week open label safety and tolerability trial. In this study, a total of 35 subjects with primary lateral sclerosis PLS or upper motor neuron predominate ALS will be enrolled. At the initial screening evaluation, a baseline T25FW will be obtained. This baseline test wi...
What is the current status of trial NCT02868567?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2016-03. Estimated completion is 2026-07.
What conditions does trial NCT02868567 study?
This clinical trial studies the following conditions: Motor Neuron Disease, Upper. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02868567?
The interventions under investigation include: dalfampridine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02868567?
This trial is sponsored by Hospital for Special Surgery, New York, which has 141 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02868567 being conducted?
This trial has 3 study locations across Florida, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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