Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Allergan
Study ID
NCT03855137
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Atogepant 30 mg — DRUG
    Tablets containing 30 mg atogepant
  • Atogepant 60 mg — DRUG
    Tablets containing 60 mg atogepant
  • Placebo — DRUG
    30 mg/60 mg tablets containing atogepant-matching placebo

Study Details

This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.

Key Dates

Start date
Mar 11, 2019
Status verified
Jan 2023
Primary completion
Jan 20, 2022
Completion
Jan 20, 2022

Study Design

Enrollment
778 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participants received atogepant-matching placebo tablets, orally, twice daily (BID) for 12 weeks in a double-blind (DB) treatment period.
  • Active Comparator: Atogepant 30 mg BID
    Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period.
  • Active Comparator: Atogepant 60 mg QD
    Participants received atogepant 60 mg, orally, once daily (QD) along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period.

Primary Outcome Measure

Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population [ Time Frame: Baseline to Week 12 ]

Locations (41)

FacilityCityStateZIPSite coordinators
Barrow Neuro Institute /ID# 236776PhoenixArizona85013-
Baptist Health Center for Clinical Research /ID# 237361Little RockArkansas72205-
California Headache and Balance Center /ID# 236246FresnoCalifornia93720-
Wr-Pri Llc /Id# 236008Los AlamitosCalifornia90720-
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237692Newport BeachCalifornia92660-
Schuster Medical Research Institute /ID# 236447Sherman OaksCalifornia91403-
Alpine Clinical Research Center /ID# 234346BoulderColorado80301-1880-
George Washington University Medical Faculty Associates /ID# 238011Washington D.C.District of Columbia20037-3201-
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237161St. PetersburgFlorida33709-3113-
Accel Research Sites - Tampa Clinical Research Unit /ID# 237485TampaFlorida33634-
Premiere Research Institute - Palm Beach /ID# 238192West Palm BeachFlorida33407-3209-
NeuroTrials Research Inc. /ID# 237364AtlantaGeorgia30328-
Josephson-Wallack-Munshower Neurology - NE /ID# 238234IndianapolisIndiana46256-4692-
Collective Medical Research /ID# 236400Prairie VillageKansas66208-
Ochsner Clinic Foundation /ID# 236543CovingtonLouisiana70433-8107-
Beth Israel Deaconess Medical Center /ID# 237540BostonMassachusetts02215-5400-
BTC of New Bedford /ID# 236384New BedfordMassachusetts02740-
Clinical Research Institute, Inc /ID# 238299MinneapolisMinnesota55402-2606-
Headache Neurology Research Institute /ID# 236464RidgelandMississippi39157-
Nevada Headache Institute /ID# 236420Las VegasNevada89113-
Dartmouth-Hitchcock Medical Center /ID# 237444LebanonNew Hampshire03756-
Albuquerque Clinical Trials, Inc /ID# 236853AlbuquerqueNew Mexico87102-
Albany Medical Center Rheumatology /ID# 236540AlbanyNew York12208-3412-
Dent Neurosciences Research Center, Inc. /ID# 237040AmherstNew York14226-
Headache Wellness Center /ID# 236431GreensboroNorth Carolina27405-
Raleigh Neurology Associates /ID# 237141RaleighNorth Carolina27607-
Stetson-University of Cincinnati /ID# 236453CincinnatiOhio45219-
Abington Neurological Associates - Abington /ID# 236258AbingtonPennsylvania19001-
Preferred Primary Care Physicians, Inc. /ID# 236439PittsburghPennsylvania15236-
WR-ClinSearch /ID# 238288ChattanoogaTennessee37421-1605-
Clinical Neuroscience Solutions - Memphis /ID# 237478MemphisTennessee38119-
DiscoveResearch, Inc /ID# 236274BryanTexas77802-
Texas Neurology /ID# 236359DallasTexas75214-
University of Texas Southwestern Medical Center /ID# 236941DallasTexas75390-7208-
Highland Clinical Research /ID# 237816Salt Lake CityUtah84124-
J. Lewis Research, Inc. / Foothill Family Clinic /ID# 236395Salt Lake CityUtah84109-
J. Lewis Research, Inc. Foothill Family Clinic South /ID# 236297Salt Lake CityUtah84121-
MedStar Georgetown Neurology /ID# 236324McLeanVirginia22101-
Sentara Neurology Specialists - Virginia Beach /ID# 234349Virginia BeachVirginia23456-0019-
Northwest Clinical Research Center /ID# 237581BellevueWashington98007-
Puget Sound Neurology /ID# 236321TacomaWashington25328-

Find similar trials in Phoenix, AZ

By condition
Migraine
By specialty
Neurology
By research site
Barrow Neuro Institute· Phoenix, AZBaptist Health Center for Clinical Research· Little Rock, ARCalifornia Headache and Balance Center· Fresno, CAWr-Pri Llc· Los Alamitos, CAPharmacology Research Institute (PRI) - Newport Beach (Wake)· Newport Beach, CASchuster Medical Research Institute· Sherman Oaks, CA

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