Valproate Versus Ketorolac Versus Metoclopramide

Acute Migraine Clinical Trial

Official title:

IV Valproate for Acute Migraine. A Randomized Comparison Versus IV Metoclopramide and IV Ketorolac

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267864
• Other study ID #: 10-01-009
• Status: Completed
• Phase: Phase 4
• Start date: November 2010
• Est. completion date: March 2013

Study information

• Verified date: May 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Migraine
• Migraine Disorders

Intervention

Drug:
• Metoclopramide
10mg IVSS
• Ketorolac
30g IVSS
• Valproate
1gm IVSS

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participants Who Achieve Sustained Headache Freedom for 24 Hours	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- 24 hours after receipt of medication
Secondary	Satisfaction With Medication	% 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	24 hours
Secondary	Adverse Event	% who report any adverse event after administration of investigational medication	24 hours