A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache

Lundbeck

Status and phase: Active, not recruiting; Phase 4

Conditions: Migraine; Medication Overuse Headache

Treatments: Drug: Placebo; Drug: Eptinezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05452239

20007A

2021-003049-40 (EudraCT Number)

Details and patient eligibility

About

Medication overuse headache (MOH) is a type of headache caused by excessive use of acute headache or migraine medications (medications used to treat a headache or migraine once it begins). Treatment of MOH usually involves reducing the dose of or discontinuing acute medications.

Eptinezumab is a medication used for the preventive treatment of migraine in adults. The main goals of this trial are to learn whether eptinezumab helps reduce the number of days with migraine, the number of days with headache, and acute medication use in adults who have migraine and MOH.

Full description

The total study duration from screening visit to safety follow-up visit is approximately 36 weeks and includes a screening period (4 weeks), a placebo-controlled period (12 weeks), an open-label period (12 weeks), and a safety follow-up period (8 weeks).

Enrollment: 570 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The participant has a diagnosis of migraine or MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit.
• The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
• The participant has ≥15 headache days per month for each month within the past 3 months prior to the Screening Visit.
• The participant has had an onset of migraine diagnosis at ≤50 years of age.

Exclusion criteria

• The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome).
• The participant has a diagnosis of acute or active temporomandibular disorders.
• The participant 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), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
• The participant has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6 months prior to the Screening Visit.
• The participant 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).

Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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570 participants in 2 patient groups, including a placebo group

Eptinezumab

Experimental group

Description:

Participants will receive an intravenous (IV) infusion of eptinezumab at Week 0 and Week 12.

Treatment:

Drug: Eptinezumab

Placebo

Placebo Comparator group

Description:

Participants will receive a single IV infusion of matching placebo to eptinezumab at Week 0. Then, all participants will receive a single IV infusion of eptinezumab at Week 12.

Treatment:

Drug: Eptinezumab

Drug: Placebo