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

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

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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