Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine (Sunrise)

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210093

Enrollment

315

Registered

2021-05-17

Start date

2021-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Interventions

Eptinezumab 100 mg, eptinezumab 300 mg or placebo administered intravenously

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - The patient has a diagnosis of CM as defined by IHS ICHD-3 guidelines confirmed at screening visit with a history of migraine onset at least 12 months prior to the Screening Visit. - The patient has had a diagnosis of migraine at = 8 migraine days per month for each month within the past 3 months prior to the Screening Visit. - The patient fulfils the following criteria for migraine in prospectively collected information in the eDiary during the screening period: - Migraine occurring on >=8 days and headache occurring on >=15 to =18 (>=20 for Taiwan) and <=75 years at the Screening Visit.

Exclusion criteria

Exclusion criteria: - The patient has received any medication targeting the calcitonin generelated peptide (CGRP) pathway as preventive treatment of migraine. - The patient has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome). - The patient has a diagnosis of acute or active temporomandibular disorder. - The patient has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration). - The patient has a lifetime history of psychosis, bipolar mania, or dementia. - Patients with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to screening are also excluded. - The patient has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).

Design outcomes

Primary

Measure	Time frame
Change from baseline in the number of monthly migraine days (MMDs) (Weeks 1-12) [Time Frame: Weeks 1-12]	—

Countries

China, Georgia, Japan, Poland, Republic of Korea, Slovakia, Spain, Taiwan

Contacts

Public ContactTakanori Narita

PPD-SNBL K.K.

Takanori.Narita@ppd.com+81-80-8027-6361

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026