A Randomized Trial of Valproate Versus Ketorolac Versus Metoclopramide for Acute Migraine

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Montefiore Medical Center
Sponsor:
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01267864
First received: December 15, 2010
Last updated: October 27, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Acute Migraine
Drug: Metoclorpamide
Drug: Ketorolac
Drug: Valproate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: IV Valproate for Acute Migraine. A Randomized Comparison Versus IV Metoclopramide and IV Ketorolac

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Headache level [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    Verbal Numerical Rating scale for pain. Absolute change from baseline


Secondary Outcome Measures:
  • Sustained pain free [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    % achieving a pain free state within two hours and maintaining the pain free state for 24 hours

  • Satisfaction with medication [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    % who answer the following question affirmatively at 24 hours: Do you want to receive the same medication the next time you present to an ER with an acute migraine

  • Adverse event [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    % who report any adverse event after administration of investigational medcation


Estimated Enrollment: 330
Study Start Date: November 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metoclopramide
Metoclopramide 10mg IVSS
Drug: Metoclorpamide
10mg IVSS
Active Comparator: Ketorolac
Ketorolac 30mg IV
Drug: Ketorolac
30g IVSS
Active Comparator: Valproate
1gm IV
Drug: Valproate
1gm IVSS

Detailed Description:

One million patients present to US emergency departments (ED) annually for treatment of acute migraine headache. A variety of parenteral medications are used to treat acute migraine, but none offer rapid and complete headache relief without side effects. Preliminary studies have suggested that intravenous valproate, an anti-epileptic medication with established efficacy as a migraine preventive, may be useful for the treatment of acute migraine. We propose a randomized, comparative efficacy trial in which intravenous valproate is compared to two standard parenteral therapies for acute migraine. There will not be a placebo control. Included subjects will be adults 64 years and younger who meet International Headache Society criteria for acute migraine, who do not have clinical evidence of secondary (organic) headache, and who do not have allergy or contra-indication to the investigational medications. The investigational medications are 1gm of valproate, 10mg of metoclopramide, and 30mg of ketorolac. Patients will be approached for participation and randomized at the time of presentation to the ED. Pain will be assessed on an 11 point (0 to 10) verbal pain scale, validated for use in acute pain trials. Medication will be infused as a slow intravenous drip. The primary outcome will be an improvement in headache intensity one hour after initiation of the intravenous drip. Secondary outcomes include assessments of pain, functional disability, adverse events, and satisfaction with the investigational medication one, two and 24 hours after initiation of the intravenous drip. The primary analysis will use a Student's t-test for independent samples and involve three pair-wise comparisons. Using an alpha of .017 (to account for the three pairwise comparisons), a standard beta, and a validated minimum clinically significant difference on the verbal pain scale, we calculated the need for 330 subjects. An interim analysis will be conducted to determine lack of efficacy of valproate.

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IHS migraine without aura
  • IHS probable migraine (all migraine without arua criteria must be met except duration may be >72 hours or <4 hours)

Exclusion Criteria:

  • Allergy or contra-indication to investigational medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267864

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Benjamin W Friedman, MD, MS    718-920-6626    bwfriedmanmd@gmail.com   
Principal Investigator: Benjamin W Friedman, MD, MS         
Sponsors and Collaborators
Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Benjamin Friedman, Associate professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01267864     History of Changes
Other Study ID Numbers: Migraine4
Study First Received: December 15, 2010
Last Updated: October 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
migraine
emergency
metoclopramide
ketorolac
valproate

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Valproic Acid
Ketorolac
Ketorolac Tromethamine
Metoclopramide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Anti-Inflammatory Agents, Non-Steroidal

ClinicalTrials.gov processed this record on August 25, 2014