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NCT01071317 · ClinicalTrials.gov registry record · Phase 4
Trial of Comprehensive Migraine Intervention
A Phase 4 study, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT01071317: Completed Phase 4 study, sponsored by Montefiore Medical Center.
NCT01071317 is a Phase 4 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01071317, a Phase 4 study, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study Summary
Despite the fact that more than 10% of Americans suffer from migraine, this headache disorder is often not diagnosed and not appropriately treated. The goal of this proposal is to determine whether a migraine protocol designed for use in an emergency room can be used to deliver the headache care that many migraine patients never receive. This is a randomized trial. Consecutive inadequately treated migraine patients will be randomized to TYPICAL care or to COMPREHENSIVE care. Those patients in the comprehensive care arm will receive the following intervention: 1) reinforcement of diagnosis, 2) an adaptable online educational intervention, reading material, and headache diaries, 3) two migraine specific medications and 4) expedited referral to a headache specialist, if needed. Patients in the typical care arm will receive whatever intervention the emergency physician feels is most appropriate. Headache surveys will be used toll if the protocol improves migraine-related pain and functional disability one month after the ER visit.
Primary Outcome
This is a standardized instrument commonly used in migraine research. Participants answer 6 Likert questions about the impact of migraine on their daily life. A score of 36, the lowest possible score, indicates minimal functional impairment. A score of 78, the highest possible score, indicates substantial functional impairment
Interventions
- DRUG Naproxen
- DRUG Sumatriptan
- BEHAVIORAL Migraine education
- BEHAVIORAL Reenforcement of diagnosis
- OTHER Typical care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-02 |
| Est. Completion | 2012-01 |
| Phase | Phase 4 |
What the finished NCT01071317 record still lists
NCT01071317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 5 interventions - of which Naproxen is the first listed.
NCT01071317 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01071317 about?
NCT01071317 is a clinical study titled "Trial of Comprehensive Migraine Intervention". Despite the fact that more than 10% of Americans suffer from migraine, this headache disorder is often not diagnosed and not appropriately treated. The goal of this proposal is to determine whether a migraine protocol designed for use in an emergency room can be used to deliver the headache care tha...
What is the current status of trial NCT01071317?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2010-02. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01071317?
The interventions under investigation include: Naproxen (DRUG), Sumatriptan (DRUG), Migraine education (BEHAVIORAL), Reenforcement of diagnosis (BEHAVIORAL), Typical care (OTHER).
Who is sponsoring clinical trial NCT01071317?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01071317's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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