IM Ketorolac vs Cambia for the Acute Treatment of Severe Migraine

Study Overview
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Brief Summary
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This research will be conducted to see if the oral drug Cambia is as effective in relieving severe migraine headaches as the injectable drug ketorolac.

Detailed Description
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The treatment of severe migraine often requires a patient office visit or treatment in the ER or urgent care setting. This is due to the minimal efficacy of PO treatments once migraine is severe, and therefore the need for parenteral treatments. IM Ketorolac is one mainstay of parenteral treatment. There is an unmet need for effective at-home treatment regimens for severe migraine. Despite FDA approval of Cambia for acute migraine treatment, insurance is reticent to cover the treatment due to higher cost in comparison to generic diclofenac tablets, despite superior efficacy of Cambia in comparison to generic diclofenac tablets (Diener, Cephalalgia 2006). One objective of this study would be to provide rationale to justify the insurance coverage of this treatment in comparison to generic tablets, because at home treatment is less costly than office visit or emergency department visit to receive IM ketorolac. A previous study of Cambia demonstrated that this formulation of diclofenac potassium for oral solution is effective in reducing pain intensity within 30 minutes, which may be related to the 15-minute Tmax associated with this formulation. The rapid-onset benefits were sustained through 24 hours post-treatment (Lipton, Cephalalgia 2010)

Official Title
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IM Ketorolac vs Diclofenac Potassium Powder for Oral Solution (Cambia) for the Acute Treatment of Severe Migraine

Conditions
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Migraine Headache

Intervention / Treatment
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* Drug: Diclofenac postassium powder for oral solution and placebo injection
* Drug: Ketorolac intramuscular injection and placebo oral solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet IHS criteria for migraine Age 18 to 65 At least 2 migraine attacks per month Able to give written consent Willing to complete the entire course of the study Current headache duration greater than or equal to 36 hours Exclusion Criteria: Pregnant or nursing Significant medical or psychiatric disease History of gastritis, gastric ulcer, GI bleed Renal insufficiency Hepatic insufficiency History of opioid dependence within the last 10 years or currently Any current or prior use of DICLOFENAC POTASSIUM POWDER FOR ORAL SOLUTION (CAMBIA) Past allergic reaction to DICLOFENAC or other NSAIDs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cambia<br>Diclofenac postassium powder for oral solution and placebo injection | Drug: Diclofenac postassium powder for oral solution and placebo injection<br>* Diclofenac postassium powder for oral solution 50 mg in 1 ounce water orally, single dose and placebo normal saline 2ml intramuscular injection, single dose<br>* Other names: Cambia;|
| Active Comparator: ketorolac<br>ketorolac intramuscular injection and placebo oral solution | Drug: Ketorolac intramuscular injection and placebo oral solution<br>* ketorolac 60 mg in 2 ml intramuscular injection, single dose and placebo oral solution, 1 ounce, single dose<br>* Other names: Toradol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief, 0-3 scale |  | Change from baseline pain rating at 5, 10, 15, 30, and 60 minutes post intervention | 
| Pain free response, 0-3 scale |  | 2 hours post intervention | 
| Sustained pain free response, 0-3 scale |  | 24 hours post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in severity of migraine associated symptoms | Disability, Nausea, Photophonia/phonophobia self reported using a 0-3 rating scale | 5, 10, 15, 30, 60, 120 minutes and 24 hours post intervention | 
| Return to function | Severity, Disability, Nausea, Photophonia/phonophobia self reported as 0 on 0-3 scale | 24 hours post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Migraine Headache