Migraine Headache
Conditions
Keywords
Severe Migraine Headache
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)
Interventions
DRUGDiclofenac 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
DRUGKetorolac intramuscular injection and placebo oral solution
ketorolac 60 mg in 2 ml intramuscular injection, single dose and placebo oral solution, 1 ounce, single dose
Sponsors
Depomed
Scripps Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactEmily Rubenstein Engel, MD
Outcome results
None listed