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NCT01581281 · ClinicalTrials.gov registry record · Phase 3
The Childhood and Adolescent Migraine Prevention Study
A Phase 3 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Terminated
- Registry status
- Phase 3
- Development phase
- 488
- Enrollment target
NCT01581281: Clinical Trial Phase 3 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT01581281 is a Phase 3 study that was terminated before completion, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 488 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01581281, a Phase 3 study, was terminated before completion, sponsored by Children's Hospital Medical Center, Cincinnati.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 488 participants
- Enrollment target
Study Summary
The purpose of this research study is to test two medicines for migraine prevention in children and adolescents.
Primary Outcome
The primary endpoint was a ≥ 50% reduction in headache frequency from the 28 days (4 weeks) baseline period prior to randomization to the last 28 days (4 weeks) of the trial. Headache frequency was defined as the number of days with headache for a given four week 28 day (4 week) period. A headache day was defined as any day during which any headache occurs within a 24 hour period, starting and ending at midnight. For each participant, the primary endpoint involved a determination of whether a 5
Interventions
- DRUG Placebo
- DRUG Amitriptyline
- DRUG Topiramate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 488 participants |
| Start Date | 2012-06 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
Why NCT01581281 stopped before completion
NCT01581281 is an interventional study that assigns participants to a tested intervention. The registered 488 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01581281 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01581281 about?
NCT01581281 is a clinical study titled "The Childhood and Adolescent Migraine Prevention Study". The purpose of this research study is to test two medicines for migraine prevention in children and adolescents.
What is the current status of trial NCT01581281?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 488 participants. The study started on 2012-06. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01581281?
The interventions under investigation include: Placebo (DRUG), Amitriptyline (DRUG), Topiramate (DRUG).
Who is sponsoring clinical trial NCT01581281?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01581281's enrollment target sits among peer trials
488 784th of 2000 higher than 1,215 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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