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Clinical trial

Dexamethasone for Acute Migraine. A Randomized Dose-comparison Study

ID
Name
2019-10562
Description
Dexamethasone is an evidence-based treatment of acute migraine. This is a randomized comparison of two different doses of dexamethasone for acute migraine. All patients will also be treated with metoclopramide.
Trial arms
Trial start
2019-12-22
Estimated PCD
2022-12-31
Trial end
2022-12-31
Status
Completed
Phase
Early phase I
Treatment
Dexamethasone 4mg
Dexamethasone 4mg + metoclopramide 10mg, intravenously
Arms:
Dexamethasone 4mg
Other names:
Dexasone 4 mg
Dexamethasone 16mg
Dexamethasone 16mg + metoclopramide 10mg, intravenously
Arms:
Dexamethasone 16mg
Other names:
Dexasone 16 mg
Size
209
Primary endpoint
Number of Subjects With Headaches Who Have Sustained Headache Relief for 48 Hours
48 hours
Eligibility criteria
Inclusion Criteria: * Moderate or severe migraine Exclusion Criteria: * Medication contra-indication * Concern for secondary cause of headache
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 209, 'type': 'ACTUAL'}}
Updated at
2024-03-20

1 organization

1 product

1 indication

Organization
Montefiore Medical Center
Product
Dexamethasone
Indication
Migraine