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NCT02868567 · ClinicalTrials.gov registry record · Phase 1
Use of Dalfampridine in Primary Lateral Sclerosis
A Phase 1 study of Motor Neuron Disease, Upper, sponsored by Hospital for Special Surgery, New York.
- Active
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 3
- Study locations
NCT02868567: Active Phase 1 study of Motor Neuron Disease, Upper, sponsored by Hospital for Special Surgery, New York.
NCT02868567 is a Phase 1 study of Motor Neuron Disease, Upper that is active but no longer recruiting, run by Hospital for Special Surgery, New York. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02868567, a Phase 1 study of Motor Neuron Disease, Upper, is active but no longer recruiting, sponsored by Hospital for Special Surgery, New York.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
speed of walking 25 feet
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 |
What the registry record for NCT02868567 still lists
NCT02868567 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
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.
NCT02868567 reports a single indexed study location in Florida, Massachusetts, New York.
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.
What interventions are being tested in trial NCT02868567?
The interventions under investigation include: dalfampridine (DRUG).
Who is sponsoring clinical trial NCT02868567?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02868567's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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