An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine (PREVAIL)

Alder Biopharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Migraine Disorder

Treatments: Biological: ALD403 (Eptinezumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02985398

ALD403-CLIN-013

Details and patient eligibility

About

An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine

Enrollment: 128 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females between 18 and 65 years of age, inclusive, who were diagnosed with migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months before screening.

Exclusion criteria

• Receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening.
• Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome).
• Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. Patients with a lifetime history of psychosis, mania, or dementia are excluded.
• History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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128 participants in 1 patient group

ALD403 (Eptinezumab) Dose Level 1

Experimental group

Description:

ALD403 (Eptinezumab) Dose Level 1 (IV)

Treatment:

Biological: ALD403 (Eptinezumab)