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NCT01405950 · ClinicalTrials.gov registry record · Phase 1
Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy
A Phase 1 study, sponsored by Acorda Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01405950: Clinical Trial Phase 1 study, sponsored by Acorda Therapeutics.
NCT01405950 is a Phase 1 study that was terminated before completion, run by Acorda Therapeutics. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01405950, a Phase 1 study, was terminated before completion, sponsored by Acorda Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects 2 to 16 Years Old With Mild to Moderate Spasticity Due to Cerebral Palsy.
Primary Outcome
Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine PK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp).
Interventions
- DRUG Zanaflex Capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
Why NCT01405950 stopped before completion
NCT01405950 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Zanaflex Capsules is the first listed.
NCT01405950 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01405950 about?
NCT01405950 is a clinical study titled "Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy". A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects 2 to 16 Years Old With Mild to Moderate Spasticity Due to Cerebral Palsy.
What is the current status of trial NCT01405950?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2011-05. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01405950?
The interventions under investigation include: Zanaflex Capsules (DRUG).
Who is sponsoring clinical trial NCT01405950?
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 NCT01405950's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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