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Migraine HeadachePhase 4NCT02664116

IM Ketorolac vs Cambia for the Acute Treatment of Severe Migraine

A Phase 4 study of Migraine Headache, run by Scripps Health at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine Headache
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
Jan 2016to Jul 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Emily Rubenstein Engel, MD contact

858-554-8887

Engel.EmilyRubenstein@scrippshealth.org

United States1 site, 1 recruiting

  • Scripps Clinic

    La Jolla, California, 92037

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

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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)

Being tested
Diclofenac postassium powder for oral solution and placebo injection, Ketorolac intramuscular injection and placebo oral solution
Keywords
Severe Migraine Headache
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diclofenac postassium powder for oral solution and placebo injectionDrug

    Also called Cambia

    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 solutionDrug

    Also called Toradol

    ketorolac 60 mg in 2 ml intramuscular injection, single dose and placebo oral solution, 1 ounce, single dose

Study groups in NCT02664116
Study groupRoleWhat they receive
CambiaExperimentalDiclofenac postassium powder for oral solution and placebo injection
Receives: Drug: Diclofenac postassium powder for oral solution and placebo injection
ketorolacActive comparatorketorolac intramuscular injection and placebo oral solution
Receives: Drug: Ketorolac intramuscular injection and placebo oral solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain relief, 0-3 scale

    Measured: Change from baseline pain rating at 5, 10, 15, 30, and 60 minutes post intervention

  2. Pain free response, 0-3 scale

    Measured: 2 hours post intervention

  3. Sustained pain free response, 0-3 scale

    Measured: 24 hours post intervention

Secondary outcomes (2)

  1. Change in severity of migraine associated symptoms

    Disability, Nausea, Photophonia/phonophobia self reported using a 0-3 rating scale

    Measured: 5, 10, 15, 30, 60, 120 minutes and 24 hours post intervention

  2. Return to function

    Severity, Disability, Nausea, Photophonia/phonophobia self reported as 0 on 0-3 scale

    Measured: 24 hours post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionJul 2017 (estimated)
  4. Study completionJul 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02664116
Sponsor's protocol ID
DHC-002
Status last verified
Feb 2016
First submitted
18 Jan 2016
Last updated
3 Feb 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Individual Patient Data will not be made available

Publications

  • 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.

    PubMed 25288700

  • 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.

    PubMed 25034250

  • 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.

    PubMed 24523483

  • 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.

    PubMed 23298250

  • 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.

    PubMed 20959428

  • 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.

    PubMed 1514724

  • 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.

    PubMed 24875925

  • 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.

    PubMed 25600718

  • 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.

    PubMed 16674762

  • 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.

    PubMed 31833000

Questions about this trial

What is this clinical trial studying?

A Phase 4 study of Migraine Headache, run by Scripps Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Emily Rubenstein Engel, MD (858-554-8887, Engel.EmilyRubenstein@scrippshealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain relief, 0-3 scale (time frame: Change from baseline pain rating at 5, 10, 15, 30, and 60 minutes post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02664116, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.

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