Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine

Part of paid clinical trials in Hoover, Alabama.

Sponsor
AbbVie
Study ID
NCT05216263
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 22, 2022
Status verified
May 2025
Primary completion
May 2, 2025
Completion
May 2, 2025

Study Design

Enrollment
75 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atogepant
    Participants will receive atogepant once a day (QD) during the 24-week treatment period.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 28 Weeks ]

Locations (29)

FacilityCityStateZIPSite coordinators
Neurology and Neurodiagnostics of Alabama /ID# 242538HooverAlabama35244-5700-
Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 241812PhoenixArizona85013-
Arkansas Clinical Research /ID# 241789Little RockArkansas72205-
Hope Clinical Research /ID# 241772Canoga ParkCalifornia91303-
Profound Research LLC /ID# 244084CarlsbadCalifornia92011-4213-
Neuro Pain Medical Center /ID# 241992FresnoCalifornia93710-5473-
Neurological Research Institute /ID# 242688Santa MonicaCalifornia90404-
Neurology Offices of South Florida, PLLC /ID# 242693Boca RatonFlorida33428-2231-
Coastal Clinical Research Specialists /ID# 247992Jacksonville BeachFlorida32250-1694-
University of Miami /ID# 252230MiamiFlorida33136-
First Physicians Group - Waldemere /ID# 242861SarasotaFlorida34239-2943-
Kansas Institute of Research /ID# 241796Overland ParkKansas66211-1363-
Ochsner Clinic Foundation /ID# 241803CovingtonLouisiana70433-8107-
Beth Israel Deaconess Medical Center /ID# 241800BostonMassachusetts02215-5400-
Michigan Headache & Neurological Institute (MHNI) /ID# 241784Ann ArborMichigan48104-5131-
Minneapolis Clinic of Neurology - Burnsville /ID# 241994BurnsvilleMinnesota55337-6732-
Albany Medical College /ID# 242757AlbanyNew York12208-
Dent Neurologic Institute - Amherst /ID# 241776AmherstNew York14226-
Headache Wellness Center /ID# 241791GreensboroNorth Carolina27405-
Jefferson Hospital for Neuroscience /ID# 243712PhiladelphiaPennsylvania19107-5191-
Preferred Primary Care Physicians - Jacob Murphy /ID# 241798UniontownPennsylvania15401-
Chattanooga Medical Research /ID# 253295ChattanoogaTennessee37404-3239-
Nashville Neuroscience Group /ID# 243592NashvilleTennessee37203-
Texas Neurology /ID# 241795DallasTexas75214-
Inova Health System /ID# 252242Falls ChurchVirginia22042-
Integrated Neurology Services - Falls Church /ID# 244747Falls ChurchVirginia22043-2367-
Puget Sound Neurology /ID# 241787TacomaWashington25328-
Frontier Clinical Research - Kingwood /ID# 242928KingwoodWest Virginia26537-9797-
West Virginia Univ School Med /ID# 252869MorgantownWest Virginia26506-

Find similar trials in Hoover, AL

By condition
Migraine
By specialty
Neurology
By research site
Neurology and Neurodiagnostics of Alabama· Hoover, ALBarrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr· Phoenix, AZArkansas Clinical Research· Little Rock, ARHope Clinical Research· Canoga Park, CAProfound Research LLC· Carlsbad, CANeuro Pain Medical Center· Fresno, CA

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