IM Ketorolac vs Cambia for the Acute Treatment of Severe Migraine

Phase 4

• Conditions: Migraine Headache
• Interventions: Drug: Diclofenac postassium powder for oral solution and placebo injection; Drug: Ketorolac intramuscular injection and placebo oral solution

• Registration Number: NCT02664116
• Lead Sponsor: Scripps Health

Brief Summary

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

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)

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-26
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-01
• Last Update Posted: 2016-02-03
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cambia	Diclofenac postassium powder for oral solution and placebo injection	Diclofenac postassium powder for oral solution and placebo injection
ketorolac	Ketorolac intramuscular injection and placebo oral solution	ketorolac intramuscular injection and placebo oral solution

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Scripps Clinic; 🇺🇸 La Jolla, California, United States