Valproate Versus Ketorolac Versus Metoclopramide
IV Valproate for Acute Migraine. A Randomized Comparison Versus IV Metoclopramide and IV Ketorolac
1 other identifier
interventional
330
1 country
1
Brief Summary
This randomized study is testing 3 different intravenous medications to see which one is best for acute migraine. The three medications are metoclopramide, valproate, and ketorolac.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2010
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 15, 2010
CompletedFirst Posted
Study publicly available on registry
December 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
June 4, 2018
CompletedJune 4, 2018
May 1, 2018
2.3 years
December 15, 2010
March 25, 2014
May 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Headache Pain Level on a 0-10 Verbal Scale
Verbal Numerical Rating scale for pain. Absolute change from baseline. This is a 0-10 scale on which 0= no pain and 10= the worst pain imaginable.
60 minutes after receipt of medication
Secondary Outcomes (3)
Participants Who Achieve Sustained Headache Freedom for 24 Hours
2- 24 hours after receipt of medication
Satisfaction With Medication
24 hours
Adverse Event
24 hours
Study Arms (3)
Metoclopramide
ACTIVE COMPARATORMetoclopramide 10mg IVSS
Ketorolac
ACTIVE COMPARATORKetorolac 30mg IV
Valproate
ACTIVE COMPARATOR1gm IV
Interventions
Eligibility Criteria
You may qualify if:
- IHS migraine without aura
- IHS probable migraine (all migraine without arua criteria must be met except duration may be \>72 hours or \<4 hours)
You may not qualify if:
- Allergy or contra-indication to investigational medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Medical Center
The Bronx, New York, 10467, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Benjamin Friedman, MD
- Organization
- Albert Einstein College of Medicine, Montefiore Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
December 15, 2010
First Posted
December 29, 2010
Study Start
November 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
June 4, 2018
Results First Posted
June 4, 2018
Record last verified: 2018-05