Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention

Allergan

Status and phase: Completed; Phase 3; Phase 2

Conditions: Migraine, With or Without Aura

Treatments: Drug: Atogepant; Drug: Placebo-matching Atogepant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02848326

CGP-MD-01

Details and patient eligibility

About

This study will evaluate the safety and tolerability of the following doses of atogepant (AGN-241689): 10 mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the prevention of episodic migraine and will characterize the dose/response relationship.

Enrollment: 834 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has at least a 1-year history of migraine with or without aura
• Age of the patient at the time of migraine onset < 50 years
• History of 4 to 14 migraine days (migraine/probable migraine headache days) per month on average in the 3 months prior to Visit 1 in the Investigator's judgment
• Demonstrated compliance with e-diary

Exclusion criteria

• Has a history of migraine accompanied by diplopia or decreased level of consciousness and retinal migraine
• Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
• Difficulty distinguishing migraine headache from other headaches
• Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
• Has a history of gastric or small intestinal surgery, or has a disease that causes malabsorption
• Has a history of hepatitis within previous 6 months
• Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1
• Pregnant or nursing females

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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834 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo-matching atogepant capsule orally twice daily in the morning and in the evening for 12 weeks.

Treatment:

Drug: Placebo-matching Atogepant

Atogepant 10 mg QD

Experimental group

Description:

Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.

Treatment:

Drug: Atogepant

Drug: Placebo-matching Atogepant

Atogepant 30 mg QD

Experimental group

Description:

Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.

Treatment:

Drug: Atogepant

Drug: Placebo-matching Atogepant

Atogepant 30 mg BID

Experimental group

Description:

Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.

Treatment:

Drug: Atogepant

Atogepant 60 mg QD

Experimental group

Description:

Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.

Treatment:

Drug: Atogepant

Drug: Placebo-matching Atogepant

Atogepant 60 mg BID

Experimental group

Description:

Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.

Treatment:

Drug: Atogepant