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NCT05967442 · ClinicalTrials.gov registry record · Phase 3
Magnesium Versus Prochlorperazine Versus Metoclopramide for Migraines
A Phase 3 study of Migraine and Headache, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 157
- Enrollment target
- 1
- Study location
NCT05967442 is a Phase 3 study of Migraine and Headache that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 157 participants, below the 357-participant average among 102 other Migraine trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05967442, a Phase 3 study of Migraine and Headache, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 157 participants
- Enrollment target
- 1
- Study location
Study Summary
This investigation describes a proposed clinical trial that will evaluate the relative efficacy of intravenous magnesium sulfate for the treatment of migraine compared to intravenous metoclopramide (Reglan) and intravenous prochlorperazine (Compazine) in the treatment of acute headache and migraine in adult patients. The ultimate objective will be clinical application of these drugs in the emergency department for the treatment of acute headache and migraine. The two phenothiazines (metoclopramide and prochlorperazine) have been routinely utilized in the treatment of acute headache and migraine in the emergency department setting. Per the 2017 American Headache Society guidelines, both intravenous metoclopramide and intravenous procholorperazine are recommended as "clinicians should offer" agents with level B evidence. Of note, there are no agents with level A evidence purported by this guideline for acute management of migraine. The same guideline offers "no recommendation can be made regarding the role of intravenous magnesium for adults who present to the ED with acute migraine. However intravenous magnesium may be of benefit to patients who present with migraine with aura." Multiple trials have evaluated intravenous magnesium's safety and efficacy in the management of acute migraine. These have demonstrated the tolerability of intravenous magnesium on a with breadth of patients. Most commonly the primary adverse event was flushing which self-resolved. No cases of hypotension were reported. None of these study agents have been withdrawn from the market.
Interventions
- DRUG Magnesium Sulfate
- DRUG Metoclopramide 10mg
- DRUG Prochlorperazine (Compazine) Injection
Study Locations (1)
Illinois
- Advocate Christ Medical Center - Oak Lawn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2019-08-23 |
| Est. Completion | 2023-04-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05967442
The ClinicalTrials.gov registry entry for NCT05967442 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 157 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 357-participant average among 102 other Migraine trials with a reported enrollment target (56% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Migraine appearing as the primary indexed condition, and to 3 interventions - of which Magnesium Sulfate is the first listed.
NCT05967442 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT05967442 about?
NCT05967442 is a clinical study titled "Magnesium Versus Prochlorperazine Versus Metoclopramide for Migraines". This investigation describes a proposed clinical trial that will evaluate the relative efficacy of intravenous magnesium sulfate for the treatment of migraine compared to intravenous metoclopramide (Reglan) and intravenous prochlorperazine (Compazine) in the treatment of acute headache and migraine ...
What is the current status of trial NCT05967442?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 157 participants. The study started on 2019-08-23. Estimated completion is 2023-04-06.
What conditions does trial NCT05967442 study?
This clinical trial studies the following conditions: Migraine, Headache.
What interventions are being tested in trial NCT05967442?
The interventions under investigation include: Magnesium Sulfate (DRUG), Metoclopramide 10mg (DRUG), Prochlorperazine (Compazine) Injection (DRUG).
Who is sponsoring clinical trial NCT05967442?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05967442 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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