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Valproate Versus Ketorolac Versus Metoclopramide

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ClinicalTrials.gov Identifier: NCT01267864
Recruitment Status : Completed
First Posted : December 29, 2010
Results First Posted : June 4, 2018
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE December 15, 2010
First Posted Date  ICMJE December 29, 2010
Results First Submitted Date  ICMJE March 25, 2014
Results First Posted Date  ICMJE June 4, 2018
Last Update Posted Date June 4, 2018
Study Start Date  ICMJE November 2010
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 28, 2010)
Headache level [ Time Frame: 60 minutes ]
Verbal Numerical Rating scale for pain. Absolute change from baseline
Change History Complete list of historical versions of study NCT01267864 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2018)
  • 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
  • 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
  • Adverse Event [ Time Frame: 24 hours ]
    % who report any adverse event after administration of investigational medication
Original Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2010)
  • Sustained pain free [ Time Frame: 24 hours ]
    % achieving a pain free state within two hours and maintaining the pain free state for 24 hours
  • 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
  • Adverse Event [ Time Frame: 24 hours ]
    % who report any adverse event after administration of investigational medcation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Valproate Versus Ketorolac Versus Metoclopramide
Official Title  ICMJE IV Valproate for Acute Migraine. A Randomized Comparison Versus IV Metoclopramide and IV Ketorolac
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Migraine
Intervention  ICMJE
  • Drug: Metoclopramide
    10mg IVSS
  • Drug: Ketorolac
    30g IVSS
  • Drug: Valproate
    1gm IVSS
Study Arms  ICMJE
  • Active Comparator: Metoclopramide
    Metoclopramide 10mg IVSS
    Intervention: Drug: Metoclopramide
  • Active Comparator: Ketorolac
    Ketorolac 30mg IV
    Intervention: Drug: Ketorolac
  • Active Comparator: Valproate
    1gm IV
    Intervention: Drug: Valproate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 28, 2010)
330
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01267864
Other Study ID Numbers  ICMJE 10-01-009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Benjamin W. Friedman, MD, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Montefiore Medical Center
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP