Study Summary
This trial seeks to prove the combo of OnabotulinumtoxinA and CGRPmAbs is effective for chronic migraine, which may help patients get better coverage.
- Chronic Migraine
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 6 months
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
1 Treatment Group
Combination of Botox + CGRPmAb
1 of 1
Experimental Treatment
50 Total Participants · 1 Treatment Group
Primary Treatment: Combination of Botox + CGRPmAb · No Placebo Group · Phase 4
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 75 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Goadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA. A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132. doi: 10.1056/NEJMoa1705848.
- Dodick DW, Ashina M, Brandes JL, Kudrow D, Lanteri-Minet M, Osipova V, Palmer K, Picard H, Mikol DD, Lenz RA. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018 May;38(6):1026-1037. doi: 10.1177/0333102418759786. Epub 2018 Feb 22.
- Stauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR. Evaluation of Galcanezumab for the Prevention of Episodic Migraine: The EVOLVE-1 Randomized Clinical Trial. JAMA Neurol. 2018 Sep 1;75(9):1080-1088. doi: 10.1001/jamaneurol.2018.1212. Erratum In: JAMA Neurol. 2019 Jul 1;76(7):872.
- Skljarevski V, Matharu M, Millen BA, Ossipov MH, Kim BK, Yang JY. Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. 2018 Jul;38(8):1442-1454. doi: 10.1177/0333102418779543. Epub 2018 May 31.
- Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E. Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial. JAMA. 2018 May 15;319(19):1999-2008. doi: 10.1001/jama.2018.4853.
- Ferrari MD, Diener HC, Ning X, Galic M, Cohen JM, Yang R, Mueller M, Ahn AH, Schwartz YC, Grozinski-Wolff M, Janka L, Ashina M. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. 2019 Sep 21;394(10203):1030-1040. doi: 10.1016/S0140-6736(19)31946-4. Epub 2019 Aug 16. Erratum In: Lancet. 2019 Oct 29;:
- Blumenfeld AM, Frishberg BM, Schim JD, Iannone A, Schneider G, Yedigarova L, Manack Adams A. Real-World Evidence for Control of Chronic Migraine Patients Receiving CGRP Monoclonal Antibody Therapy Added to OnabotulinumtoxinA: A Retrospective Chart Review. Pain Ther. 2021 Dec;10(2):809-826. doi: 10.1007/s40122-021-00264-x. Epub 2021 Apr 21.
- Bradley Torphy, MD 2023. "COACT Study: CGRPmAbs + OnabotulinumtoxinA Assessment of Chronic Migraine Treatments Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05724771.
Frequently Asked Questions
Is it possible for me to join this clinical trial?
"A prerequisite for enrolment in this medical trial is chronic migraine and a patient's age must fall between 18 - 75. This research program has an allocated recruitment quota of 50 participants." - Anonymous Online Contributor
Is enrollment into this experiment available at the present time?
"As indicated by the clinicaltrials.gov portal, this medical trial is recruiting participants at present. The post was issued on January 26th 2023 and recently modified on February 2nd of the same year." - Anonymous Online Contributor
Does this study accept participants aged 55 and older?
"To be eligible for this trial, potential participants must range from 18 to 75 years old. Seperate trials exist for those under 18 (42 studies) and over 65 (177 studies)." - Anonymous Online Contributor
What risks and benefits come with the Combination of Botox + CGRPmAb treatment?
"This combination of Botox and CGRPmAb has been given a score of 3, as it is currently in Phase 4 trials - meaning approval has already been granted." - Anonymous Online Contributor
How many individuals are being enrolled in this inquiry?
"Affirmative. According to clinicaltrials.gov, this medical trial is presently in search of participants and was introduced on January 26th 2023 with a recent update occurring February 2nd 2023. It needs 50 patients from one location to complete the study." - Anonymous Online Contributor