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| Name | Class |
|---|---|
| Depomed | INDUSTRY |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cambia | Experimental | Diclofenac postassium powder for oral solution and placebo injection |
|
| ketorolac | Active Comparator | ketorolac intramuscular injection and placebo oral solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac postassium powder for oral solution and placebo injection | Drug | Diclofenac postassium powder for oral solution 50 mg in 1 ounce water orally, single dose and placebo normal saline 2ml intramuscular injection, single dose |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Return to function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily Rubenstein Engel, MD | Contact | 858-554-8887 | Engel.EmilyRubenstein@scrippshealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Emily Rubenstein Engel, MD | Scripps Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic | Recruiting | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25288700 | Background | 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. No abstract available. | |
| 25034250 | Background | 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. |
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Individual Patient Data will not be made available
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D012996 | Solutions |
| D004008 | Diclofenac |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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|
| Ketorolac intramuscular injection and placebo oral solution | Drug | ketorolac 60 mg in 2 ml intramuscular injection, single dose and placebo oral solution, 1 ounce, single dose |
|
|
Severity, Disability, Nausea, Photophonia/phonophobia self reported as 0 on 0-3 scale
| 24 hours post intervention |
| 24523483 | Background | 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. |
| 23298250 | Background | 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. |
| 20959428 | Background | 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. |
| 1514724 | Background | 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. doi: 10.1016/s0196-0644(05)80654-7. |
| 24875925 | Background | Orr SL, Aube 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. |
| 25600718 | Background | 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. |
| 16674762 | Background | Diener HC, Montagna P, Gacs G, Lyczak P, Schumann G, Zoller 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. doi: 10.1111/j.1468-2982.2005.01064.x. |
| 31833000 | Derived | Engel ER, Cheng J. IM ketorolac vs diclofenac potassium powder for oral solution for the acute treatment of severe migraine: a randomized controlled trial. Neurol Sci. 2020 Mar;41(3):537-542. doi: 10.1007/s10072-019-04157-y. Epub 2019 Dec 12. |
| D009422 | Nervous System Diseases |
| D009930 |
| Organic Chemicals |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |