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

  • STATUS
    Recruiting
  • End date
    Feb 11, 2022
  • participants needed
    750
  • sponsor
    Allergan
Updated on 24 July 2021
Investigator
Clinical Trials Registry Team
Primary Contact
Raleigh Neurology Associates, P.A (3.7 mi away) Contact
+178 other location
migraine
headache

Summary

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

Details
Condition Chronic Migraine
Treatment Placebo, Atogepant 60 mg, Atogepant 30 mg
Clinical Study IdentifierNCT03855137
SponsorAllergan
Last Modified on24 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

At least a 1-year history of CM consistent with a diagnosis according to the ICHD-3, 2018
Age of the participant at the time of migraine onset < 50 years
Confirmation of headache/migraine headache day frequency as follows
History of, on average, 15 headache days per month in the 3 months prior to Visit 1 in the opinion of the investigator AND
headache days during the 4-week screening/baseline period per the electronic diary (eDiary) AND
days during the 4-week screening/baseline period that qualify as being a migraine day per the eDiary
Participants must be using a medically acceptable and effective method of birth control during the course of the entire study

Exclusion Criteria

Has a history of migraine, accompanied by diplopia or decreased level of consciousness, or retinal migraine
Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
History of an inadequate response to > 4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine
Woman is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1 and Visit 2
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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