La Jolla, California 92037

  • Migraine Headache

Purpose:

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.


Study summary:

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)


Criteria:

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


NCT ID:

NCT02664116


Primary Contact:

Principal Investigator
Emily Rubenstein Engel, MD
Scripps Health

Emily Rubenstein Engel, MD
Phone: 858-554-8887
Email: Engel.EmilyRubenstein@scrippshealth.org


Backup Contact:

N/A


Location Contact:

La Jolla, California 92037
United States

Emily Rubenstein Engel, M.D.
Phone: 858-554-8887
Email: Engel.EmilyRubenstein@scrippshealth.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 02, 2022

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.