Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine (ECLIPSE)

AbbVie

Status and phase: Enrolling; Phase 3

Conditions: Migraine

Treatments: Drug: Placebo for Atogepant; Drug: Atogepant

Study type: Interventional

Funder types: Industry

Identifiers

NCT06241313

M24-305

2023-506029-12-00 (Other Identifier)

Details and patient eligibility

About

A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often accompanied by throbbing, sensitivity to light, sensitivity to sound, nausea, or other symptoms. The main goal of the study is to see if atogepant is effective, safe, and well-tolerated in treating migraine attacks quickly.

Atogepant is a medicine currently approved for the preventive treatment of migraine in adults and has been shown to be effective and well tolerated when taken daily to prevent migraine attacks. This study includes double-blind phase means that neither the participants nor the study doctors know who is given which study treatment (atogepant or placebo) followed by an open-label phase meaning that both participants and study doctors know which study treatment is given. All participants will receive atogepant during the open-label part of the study. This study will include 1300 participants aged 18-75 years with a history of migraine at approximately 160 sites across the world.

All participants will receive both atogepant and placebo to treat qualifying migraines. At the start of the study, participants will be randomized to 1 of 4 dosing sequences to determine when they will receive atogepant and when they will receive placebo during the study. After treating 4 qualifying migraine attacks, participants will receive open-label atogepant for any additional migraine attacks they have until the end of the study (Week 24).

There may be a bigger responsibility for participants in this study than there would be in participants receiving standard of care treatment. participants will attend regular visits during the study at a hospital or clinic, as well as telephone visits, and the effects of treatment will be checked by completion of questionnaires in an electronic diary, medical assessments, blood tests, and checking for side effects.

Enrollment: 1,300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of migraine (with or without aura) according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) for >= 12 months prior to Visit 1/Screening.
• History of 2 to 8 migraine attacks of moderate to severe headache pain in each of the 3 months prior to Visit 1/Screening per investigator judgment.
• Migraine onset before the age of 50.
• History of migraines lasting between 4 and 72 hours when untreated or treated unsuccessfully and migraine episodes separated by at least 48 hours of headache pain freedom.

Exclusion criteria

• History of an average of 15 or more headache days per month in the 6 months prior to Visit 1/Screening per the investigator's judgment, or a current diagnosis of chronic migraine as defined by ICHD-3.
• Require hospital/emergency room treatment for migraine attacks on 3 or more occasions within 6 months prior to Visit 1/Screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,300 participants in 4 patient groups, including a placebo group

Sequence 1

Placebo Comparator group

Description:

Participants will receive both atogepant and placebo to treat qualifying migraines.

Treatment:

Drug: Atogepant

Drug: Placebo for Atogepant

Sequence 2

Experimental group

Description:

Participants will receive both atogepant and placebo to treat qualifying migraines.

Treatment:

Drug: Atogepant

Drug: Placebo for Atogepant

Sequence 3

Experimental group

Description:

Participants will receive both atogepant and placebo to treat qualifying migraines.

Treatment:

Drug: Atogepant

Drug: Placebo for Atogepant

Sequence 4

Experimental group

Description:

Participants will receive both atogepant and placebo to treat qualifying migraines.

Treatment:

Drug: Atogepant

Drug: Placebo for Atogepant