Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine (JPN PIVOTAL)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Placebo for Atogepant; Drug: Atogepant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05861427

M22-056

Details and patient eligibility

About

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. This study will assess how safe and effective three different doses of atogepant is compared to placebo in adult Japanese participants. Change in migraine symptoms will be assessed.

Atogepant (Qulipta) is an approved drug to treat adults with episodic migraine in the United States. Participants are randomly assigned to one of the 4 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 4 chance for the participant to receive placebo. This is double-blinded study which means neither study doctor not the participant will know if the participant received atogepant or placebo. Approximately 520 adult participants with episodic migraine will be enrolled in approximately 50 sites across Japan.

Participants will receive oral atogepant or matching placebo tablets once daily for 12 weeks. At 12 weeks participants assigned to atogepant dose A, dose B or dose C will continue to receive same treatment for 12 additional weeks and participants assigned to placebo will be re-randomized to receive atogepant dose A, dose B or dose C for 12 additional weeks. All participants will be followed for 30 days following last dose of study drug.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.

Enrollment: 523 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least a 1-year history of migraine (with or without aura).
• Less than 50 years of age at the time of migraine onset.
• History of 4 to 14 migraine days per month in the 3 months prior to screening.
• 4 to 14 migraine days in the baseline period and completed at least 20 out of 28 days at the baseline period per the eDiary.

Exclusion criteria

• Difficulty with distinguishing migraine headaches from tension-type or other headaches.
• Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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523 participants in 4 patient groups

Atogepant Dose A

Experimental group

Description:

Participants will receive atogepant dose A once daily (QD) for 24 weeks.

Treatment:

Drug: Atogepant

Atogepant Dose B

Experimental group

Description:

Participants will receive atogepant dose B QD for 24 weeks.

Treatment:

Drug: Atogepant

Atogepant Dose C

Experimental group

Description:

Participants will receive atogepant dose C QD for 24 weeks.

Treatment:

Drug: Atogepant

Placebo

Experimental group

Description:

Participants will receive placebo QD for 12 weeks. Participants will be re-randomized at week 12 to receive atogepant dose A, dose B or dose C QD for 12 weeks.

Treatment:

Drug: Atogepant

Drug: Placebo for Atogepant