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Valproate Versus Ketorolac Versus Metoclopramide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01267864
Recruitment Status : Completed
First Posted : December 29, 2010
Results First Posted : June 4, 2018
Last Update Posted : June 4, 2018
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Acute Migraine Drug: Metoclopramide Drug: Ketorolac Drug: Valproate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: IV Valproate for Acute Migraine. A Randomized Comparison Versus IV Metoclopramide and IV Ketorolac
Study Start Date : November 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Active Comparator: Metoclopramide
Metoclopramide 10mg IVSS
Drug: Metoclopramide
10mg IVSS

Active Comparator: Ketorolac
Ketorolac 30mg IV
Drug: Ketorolac
30g IVSS

Active Comparator: Valproate
1gm IV
Drug: Valproate
1gm IVSS

Primary Outcome Measures :
  1. Headache Pain Level on a 0-10 Verbal Scale [ Time Frame: 60 minutes after receipt of medication ]
    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.

Secondary Outcome Measures :
  1. Participants Who Achieve Sustained Headache Freedom for 24 Hours [ Time Frame: 2- 24 hours after receipt of medication ]
    Number of participants achieving a pain free state within two hours and maintaining the pain free state for 24 hours after receipt of medication

  2. Satisfaction With Medication [ Time Frame: 24 hours ]
    % 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

  3. Adverse Event [ Time Frame: 24 hours ]
    % who report any adverse event after administration of investigational medication

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01267864

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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center

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Responsible Party: Benjamin W. Friedman, MD, Associate professor, Montefiore Medical Center Identifier: NCT01267864     History of Changes
Other Study ID Numbers: 10-01-009
First Posted: December 29, 2010    Key Record Dates
Results First Posted: June 4, 2018
Last Update Posted: June 4, 2018
Last Verified: May 2018

Keywords provided by Benjamin W. Friedman, MD, Montefiore Medical Center:

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Ketorolac Tromethamine
Valproic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
GABA Agents