Valproate Versus Ketorolac Versus Metoclopramide

NCT ID: NCT01267864

Last Updated: 2018-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-03-31

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.

Conditions

Acute Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Metoclopramide

Metoclopramide 10mg IVSS

Group Type: ACTIVE_COMPARATOR

Metoclopramide

Intervention Type: DRUG

10mg IVSS

Ketorolac

Ketorolac 30mg IV

Group Type: ACTIVE_COMPARATOR

Ketorolac

Intervention Type: DRUG

30g IVSS

Valproate

1gm IV

Group Type: ACTIVE_COMPARATOR

Valproate

Intervention Type: DRUG

1gm IVSS

Interventions

Metoclopramide

10mg IVSS

Intervention Type: DRUG

Ketorolac

30g IVSS

Intervention Type: DRUG

Valproate

1gm IVSS

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Benjamin W. Friedman, MD

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

10-01-009

Identifier Type: -

Identifier Source: org_study_id