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NCT01468350 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy
A Phase 1 study, sponsored by Acorda Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT01468350: Completed Phase 1 study, sponsored by Acorda Therapeutics.
NCT01468350 is a Phase 1 study that has completed, run by Acorda Therapeutics. 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). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01468350, a Phase 1 study, has completed, sponsored by Acorda Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
A double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (CP) to evaluate the safety and tolerability and the effect of dalfampridine extended release (ER) tablets on sensorimotor function
Primary Outcome
Safety and tolerability will be assessed primarily by monitoring Treatment Emergent Adverse Events (TEAEs) TEAEs are defined as Adverse Events (AEs) with date of onset (or worsening) on or after the start-date of double-blind treatment and no more than 5 days after the last dose of double-blind treatment for Part A of the study and no more than 9 days for Part B of the study. The severity categories of mild, moderate or severe, are defined below: * Mild is defined as causing no limitation of
Interventions
- OTHER Placebo
- DRUG dalfampridine-ER 10mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
What the finished NCT01468350 record still lists
NCT01468350 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 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01468350 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01468350 about?
NCT01468350 is a clinical study titled "Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy". A double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (CP) to evaluate the safety and tolerability and the effect of dalfampridine extended release (ER) tablets on sensorimotor function
What is the current status of trial NCT01468350?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2011-12. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01468350?
The interventions under investigation include: Placebo (OTHER), dalfampridine-ER 10mg (DRUG).
Who is sponsoring clinical trial NCT01468350?
This trial is sponsored by Acorda Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01468350'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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