Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine

Allergan

Status and phase: Completed; Phase 3

Conditions: Episodic Migraine

Treatments: Drug: Atogepant; Drug: Standard of Care (SOC) Migraine Preventive Medication

Study type: Interventional

Funder types: Industry

Identifiers

NCT03700320

3101-302-002

Details and patient eligibility

About

This study will evaluate safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year.

Enrollment: 744 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent and participant privacy information (e.g., written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures.
• Participant is a candidate to be prescribed at least one of the protocol-defined acceptable oral SOC migraine prevention medications and the participant is willing to accept SOC treatment.
• Participants must be using a medically acceptable and effective method of birth control during the course of the entire study,
• At least a 1-year history of migraine with or without aura consistent with a diagnosis
• Age of the participant at the time of migraine onset < 50 years
• History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1

Exclusion criteria

• Difficulty distinguishing migraine headaches from tension-type or other headaches
• Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine
• Has a current diagnosis of chronic migraine (CM), new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy
• ≥ 15 headache days per month on average across the 3 months prior to Visit 1
• Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment, or during the baseline period. For all participants, barbiturates are excluded 30 days prior to screening and during the baseline period. For participants randomized to atogepant, barbiturates are excluded through the duration of the study as well
• Female participant 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
• Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal (GI), or neurologic disease
• Hypertension as defined by sitting systolic blood pressure (BP) > 160 millimeter of mercury (mm Hg) or sitting diastolic BP > 100 mm Hg at Visits 1 or Visit 2. Vital sign measurements that exceed these limits may be repeated only once.
• At Visit 1, a user of recreational or illicit drugs or has had a history within the past year of drug or alcohol abuse or dependence
• History of any GI prior procedures or GI conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed are not excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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744 participants in 2 patient groups

Oral SOC Migraine Preventive Medication

Active Comparator group

Description:

Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.

Treatment:

Drug: Standard of Care (SOC) Migraine Preventive Medication

Atogepant 60 mg

Experimental group

Description:

Atogepant 60 mg tablet taken orally, once daily for 52 weeks.

Treatment:

Drug: Atogepant