Condition: Chronic Migraine · Sponsor: AbbVie
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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 tolerability of atogepant when added to BOTOX, as well as prospectively evaluate the efficacy of add-on atogepant for migraine prevention. Adverse events and change in disease activity will be monitored. Atogepant is an investigational drug being developed to prevent chronic migraine. Approximately 75 adult participants will be enrolled at approximately 30 sites in the United States. All participants will receive atogepant oral tablet once a day (QD) during the 24-week treatment period, in addition to their standard of care Botox. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: * 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 Criteria: * 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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Neurology and Neurodiagnostics of Alabama /ID# 242538 | Hoover, Alabama, United States | — |
| Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 241812 | Phoenix, Arizona, United States | — |
| Arkansas Clinical Research /ID# 241789 | Little Rock, Arkansas, United States | — |
| Hope Clinical Research /ID# 241772 | Canoga Park, California, United States | — |
| Profound Research LLC /ID# 244084 | Carlsbad, California, United States | — |
| Neuro Pain Medical Center /ID# 241992 | Fresno, California, United States | — |
| Neurological Research Institute /ID# 242688 | Santa Monica, California, United States | — |
| Neurology Offices of South Florida, PLLC /ID# 242693 | Boca Raton, Florida, United States | — |
| Coastal Clinical Research Specialists /ID# 247992 | Jacksonville Beach, Florida, United States | — |
| University of Miami /ID# 252230 | Miami, Florida, United States | — |
| First Physicians Group - Waldemere /ID# 242861 | Sarasota, Florida, United States | — |
| Kansas Institute of Research /ID# 241796 | Overland Park, Kansas, United States | — |
+ 17 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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