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IM Ketorolac vs Cambia for the Acute Treatment of Severe Migraine

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ClinicalTrials.gov Identifier: NCT02664116
Recruitment Status : Recruiting
First Posted : January 26, 2016
Last Update Posted : February 3, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Migraine Headache Drug: Diclofenac postassium powder for oral solution and placebo injection Drug: Ketorolac intramuscular injection and placebo oral solution Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: IM Ketorolac vs Diclofenac Potassium Powder for Oral Solution (Cambia) for the Acute Treatment of Severe Migraine
Study Start Date : January 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cambia
Diclofenac postassium powder for oral solution and placebo injection
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
Other Name: Cambia
Active Comparator: ketorolac
ketorolac intramuscular injection and placebo oral solution
Drug: 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
Other Name: Toradol


Outcome Measures

Primary Outcome Measures :
  1. Pain relief, 0-3 scale [ Time Frame: Change from baseline pain rating at 5, 10, 15, 30, and 60 minutes post intervention ]
  2. Pain free response, 0-3 scale [ Time Frame: 2 hours post intervention ]
  3. Sustained pain free response, 0-3 scale [ Time Frame: 24 hours post intervention ]

Secondary Outcome Measures :
  1. Change in severity of migraine associated symptoms [ Time Frame: 5, 10, 15, 30, 60, 120 minutes and 24 hours post intervention ]
    Disability, Nausea, Photophonia/phonophobia self reported using a 0-3 rating scale

  2. Return to function [ Time Frame: 24 hours post intervention ]
    Severity, Disability, Nausea, Photophonia/phonophobia self reported as 0 on 0-3 scale


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664116


Contacts
Contact: Emily Rubenstein Engel, MD 858-554-8887 Engel.EmilyRubenstein@scrippshealth.org

Locations
United States, California
Scripps Clinic Recruiting
La Jolla, California, United States, 92037
Contact: Emily Rubenstein Engel, M.D.    858-554-8887    Engel.EmilyRubenstein@scrippshealth.org   
Sponsors and Collaborators
Scripps Health
Depomed
Investigators
Principal Investigator: Emily Rubenstein Engel, MD Scripps Health
More Information

Publications:

Responsible Party: Emily Rubenstein Engel, Associate Director, Dalessio Headache Center, Scripps Clinic, Scripps Health
ClinicalTrials.gov Identifier: NCT02664116     History of Changes
Other Study ID Numbers: DHC-002
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Patient Data will not be made available

Keywords provided by Emily Rubenstein Engel, Scripps Health:
Severe Migraine Headache

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Pharmaceutical Solutions
Diclofenac
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action