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

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Allergan

Status and phase

Completed
Phase 3

Conditions

Chronic Migraine

Treatments

Drug: Placebo
Drug: Atogepant 30 mg
Drug: Atogepant 60 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT03855137
2018-004337-32 (EudraCT Number)
3101-303-002

Details and patient eligibility

About

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

Enrollment

778 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • At least a 1-year history of chronic migraine (CM) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (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
  • >=15 headache days during the 4-week screening/baseline period per the electronic diary (eDiary) AND
  • >=8 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

778 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Participants received atogepant-matching placebo tablets, orally, twice daily (BID) for 12 weeks in a double-blind (DB) treatment period.
Treatment:
Drug: Placebo
Atogepant 30 mg BID
Active Comparator group
Description:
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.
Treatment:
Drug: Atogepant 30 mg
Drug: Placebo
Atogepant 60 mg QD
Active Comparator group
Description:
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.
Treatment:
Drug: Atogepant 60 mg
Drug: Placebo

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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