View Clinical Trial (Medical Research Study)
IV Valproate for Acute Migraine. A Randomized Comparison Versus IV Metoclopramide and IV Ketorolac
| City: |
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Bronx |
| State: |
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New York |
| Zip Code: |
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10467 |
| Conditions: |
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Acute Migraine |
| Purpose: |
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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.
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| Study Summary: |
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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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| Criteria: |
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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
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| NCT ID: |
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NCT01267864 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Bronx, New York 10467
United States
Benjamin W Friedman, MD, MS
Phone: 718-920-6626
Email: bwfriedmanmd@gmail.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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