IM Ketorolac vs Cambia for the Acute Treatment of Severe Migraine

Migraine Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02664116
• Other study ID #: DHC-002
• Status: Recruiting
• Phase: Phase 4
• First received: January 18, 2016
• Last updated: February 1, 2016
• Start date: January 2016
• Est. completion date: July 2017

Study information

• Verified date: February 2016
• Source: Scripps Health
• Contact: Emily Rubenstein Engel, MD
• Phone: 858-554-8887
• Email: Engel.EmilyRubenstein[@]scrippshealth.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine Headache

Intervention

Drug:
• Diclofenac postassium powder for oral solution and placebo injection
Diclofenac postassium powder for oral solution 50 mg in 1 ounce water orally, single dose and placebo normal saline 2ml intramuscular injection, single dose
• Ketorolac intramuscular injection and placebo oral solution
ketorolac 60 mg in 2 ml intramuscular injection, single dose and placebo oral solution, 1 ounce, single dose

Locations

Country	Name	City	State
United States	Scripps Clinic	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Health	Depomed

Country where clinical trial is conducted

United States, 

References & Publications (9)

Diener HC, Montagna P, Gács G, Lyczak P, Schumann G, Zöller B, Mulder LJ, Siegel J, Edson K. Efficacy and tolerability of diclofenac potassium sachets in migraine: a randomized, double-blind, cross-over study in comparison with diclofenac potassium tablets and placebo. Cephalalgia. 2006 May;26(5):537-47. — View Citation

Duarte C, Dunaway F, Turner L, Aldag J, Frederick R. Ketorolac versus meperidine and hydroxyzine in the treatment of acute migraine headache: a randomized, prospective, double-blind trial. Ann Emerg Med. 1992 Sep;21(9):1116-21. — View Citation

Factor SA, Jankovic J. Randomized trial of IV valproate vs metoclopramide vs ketorolac for acute migraine. Neurology. 2014 Oct 7;83(15):1388-9. doi: 10.1212/01.wnl.0000455698.16732.0a. — View Citation

Friedman BW, Garber L, Yoon A, Solorzano C, Wollowitz A, Esses D, Bijur PE, Gallagher EJ. Randomized trial of IV valproate vs metoclopramide vs ketorolac for acute migraine. Neurology. 2014 Mar 18;82(11):976-83. doi: 10.1212/WNL.0000000000000223. Epub 2014 Feb 12. — View Citation

Garnock-Jones KP. Diclofenac potassium powder for oral solution: a review of its use in patients with acute migraine. CNS Drugs. 2014 Aug;28(8):761-8. doi: 10.1007/s40263-014-0186-y. Review. — View Citation

Lipton RB, Grosberg B, Singer RP, Pearlman SH, Sorrentino JV, Quiring JN, Saper JR. Efficacy and tolerability of a new powdered formulation of diclofenac potassium for oral solution for the acute treatment of migraine: results from the International Migraine Pain Assessment Clinical Trial (IMPACT). Cephalalgia. 2010 Nov;30(11):1336-45. doi: 10.1177/0333102410367523. Epub 2010 Apr 7. — View Citation

Marmura MJ, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the american headache society evidence assessment of migraine pharmacotherapies. Headache. 2015 Jan;55(1):3-20. doi: 10.1111/head.12499. Review. — View Citation

Orr SL, Aubé M, Becker WJ, Davenport WJ, Dilli E, Dodick D, Giammarco R, Gladstone J, Leroux E, Pim H, Dickinson G, Christie SN. Canadian Headache Society systematic review and recommendations on the treatment of migraine pain in emergency settings. Cephalalgia. 2015 Mar;35(3):271-84. doi: 10.1177/0333102414535997. Epub 2014 May 29. Review. — View Citation

Taggart E, Doran S, Kokotillo A, Campbell S, Villa-Roel C, Rowe BH. Ketorolac in the treatment of acute migraine: a systematic review. Headache. 2013 Feb;53(2):277-87. doi: 10.1111/head.12009. Epub 2013 Jan 8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief, 0-3 scale		Change from baseline pain rating at 5, 10, 15, 30, and 60 minutes post intervention	No
Primary	Pain free response, 0-3 scale		2 hours post intervention	No
Primary	Sustained pain free response, 0-3 scale		24 hours post intervention	No
Secondary	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	No
Secondary	Return to function	Severity, Disability, Nausea, Photophonia/phonophobia self reported as 0 on 0-3 scale	24 hours post intervention	No