IM Ketorolac vs Cambia for the Acute Treatment of Severe Migraine

Scripps Health

Status and phase: Unknown; Phase 4

Conditions: Migraine Headache

Treatments: Drug: Ketorolac intramuscular injection and placebo oral solution; Drug: Diclofenac postassium powder for oral solution and placebo injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02664116

DHC-002

Details and patient eligibility

About

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.

Full 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)

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Cambia

Experimental group

Description:

Diclofenac postassium powder for oral solution and placebo injection

Treatment:

Drug: Diclofenac postassium powder for oral solution and placebo injection

ketorolac

Active Comparator group

Description:

ketorolac intramuscular injection and placebo oral solution

Treatment:

Drug: Ketorolac intramuscular injection and placebo oral solution