Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.

Part of paid clinical trials in Colton, California.

Sponsor
Allergan
Study ID
NCT04740827
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Atogepant 60 mg — DRUG
    Atogepant tablets.
  • Placebo — DRUG
    Atogepant matching placebo tablets.

Study Details

This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared with placebo in participants with episodic migraine and who have previously failed 2 to 4 classes of oral prophylactic treatments.

Key Dates

Start date
Mar 5, 2021
Status verified
Sep 2023
Primary completion
Aug 4, 2022
Completion
Aug 4, 2022

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Participants received atogepant-matching placebo tablets, orally, once daily (QD) for up to 12 weeks in a double-blind (DB) treatment period.
  • Active Comparator: Atogepant 60 mg
    Participants received atogepant 60 mg, orally, QD 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 (26)

FacilityCityStateZIPSite coordinators
Axiom Research /ID# 226379ColtonCalifornia92324-
Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 226434EncinoCalifornia91316-
Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226388Los AlamitosCalifornia90720-3500-
Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226405Los AlamitosCalifornia90720-3500-
Excell Research, Inc /ID# 228386OceansideCalifornia92056-
Alpine Clinical Research Center /ID# 226201BoulderColorado80301-1880-
Sensible Healthcare /ID# 226197OcoeeFlorida34761-
Meridien Research /ID# 226224St. PetersburgFlorida33709-
Meridien Research /ID# 226302St. PetersburgFlorida33709-
Velocity Clinical Research - Boise /ID# 226320MeridianIdaho83642-
Allied Physicians - Fort Wayne Neurological Center /ID# 226350Fort WayneIndiana46804-
Deaconess Clinic - Gateway Health Center /ID# 226481NewburghIndiana47630-
Pharmasite Research, Inc. /ID# 226445BaltimoreMaryland21208-
StudyMetrix Research /ID# 226297City of Saint PetersMissouri63303-
Clinvest Research LLC /ID# 226273SpringfieldMissouri65807-
Methodist Physicians Clinic /ID# 226470FremontNebraska68025-
Amici Clinical Research - Raritan /ID# 226282RaritanNew Jersey08869-
Albuquerque Clinical Trials, Inc /ID# 233445AlbuquerqueNew Mexico87102-
CTI Clinical Trial and Consulting /ID# 226281CincinnatiOhio45212-
Austin Clinical Trial Partners /ID# 228387AustinTexas78737-
FutureSearch Trials of Neurology /ID# 226423AustinTexas78731-
DiscoveResearch, Inc /ID# 226491BryanTexas77802-
FutureSearch Trials of Dallas, LP /ID# 226493DallasTexas75231-
LinQ Research, LLC /ID# 226227PearlandTexas77584-
Highland Clinical Research /ID# 226288Salt Lake CityUtah84124-
Northwest Clinical Research Center /ID# 226228BellevueWashington98007-

Find similar trials in Colton, CA

By condition
Migraine
By specialty
Neurology
By research site
Axiom Research· Colton, CAPharmacology Research Institute (PRI) - Encino (Wake)· Encino, CAPharmacology Research Institute (PRI) - Los Alamitos (Wake)· Los Alamitos, CAExcell Research, Inc· Oceanside, CAAlpine Clinical Research Center· Boulder, COSensible Healthcare· Ocoee, FL

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