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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 is a Phase 4 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 50 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01071317
The ClinicalTrials.gov registry entry for NCT01071317 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Naproxen is the first listed.
NCT01071317 reports 0 study locations.
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.
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