Status:
COMPLETED
Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine
Lead Sponsor:
AbbVie
Conditions:
Chronic Migraine
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Migraine is characterized by attacks of throbbing, moderate or severe headache, often associated with nausea, vomiting, and/or sensitivity to light and/or sound. The study will assess safety and toler...
Eligibility Criteria
Inclusion
- At least a 1-year history of chronic migraine (CM), with or without aura, consistent with a diagnosis according to International Classification of Headache Disorders 3rd edition (ICHD-3 2018) and with or without acute medication overuse as defined in the protocol.
- Must be currently treated with BOTOX for CM: treated with \>= 2 treatment cycles in the 8 months prior to Visit 2 (Day 1) with documentation of payer authorization or written attestation of self-pay to support continued use of BOTOX.
- Must have 8 to 23 (inclusive) migraine days in the electronic diary \[eDiary\] screening/baseline period (eDiary data must have been collected for at least 20 days).
Exclusion
- Use of opioid-containing products for more than 4 days per month for acute treatment of headache in the 3 months prior to Screening or during the screening/baseline period.
- Treatment of study target muscles using acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, dental splints for headache, or head and/or neck injections of anesthetics/steroids within 4 weeks prior to Screening and throughout the study.
- Concurrent use of any migraine prevention treatment other than BOTOX (required concomitant medication; or topiramate \<=100mg daily) including use of oral gepants in the 4 weeks prior to screening nor during the screening/baseline period.
- Current use or use within the 6 months (24 weeks) prior to Screening, of mAbs blocking the CGRP pathway.
- Concurrent use of oral gepants for acute migraine treatment in the 4 weeks prior to screening nor during the screening/baseline period.
Key Trial Info
Start Date :
March 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05216263
Start Date
March 22 2022
End Date
May 2 2025
Last Update
May 16 2025
Active Locations (29)
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1
Neurology and Neurodiagnostics of Alabama /ID# 242538
Hoover, Alabama, United States, 35244-5700
2
Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 241812
Phoenix, Arizona, United States, 85013
3
Arkansas Clinical Research /ID# 241789
Little Rock, Arkansas, United States, 72205
4
Hope Clinical Research /ID# 241772
Canoga Park, California, United States, 91303