A Multicenter Assessment of ALD403 in Chronic Migraine

Alder Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Migraine Disorders

Treatments: Biological: Placebo; Biological: ALD403

Study type: Interventional

Funder types: Industry

Identifiers

NCT02275117

ALD403-CLIN-005

Details and patient eligibility

About

The purpose of this study is to assess ALD403 in the prevention of migraine headache in chronic migraineurs.

Enrollment: 665 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of migraine at ≤ 35 years of age with history of chronic migraine ≥ 1 year
• During the 28 day screening period, must have ≥ 15 headache days of which ≥ 8 days were assessed as migraine days with at least 5 migraine attacks as recorded in the eDiary
• Headache eDiary was completed on at least 22 of the 28 days prior to randomization

Exclusion criteria

• Confounding pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome) or any pain syndrome that requires regular analgesia
• Psychiatric conditions that are uncontrolled and untreated, including conditions that are not controlled for a minimum of 6 months prior to screening.
• History or diagnosis of complicated migraine (ICHD-III beta version, 2013), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, migraine with brainstem aura, sporadic and familial hemiplegic migraine
• Unable to differentiate migraine from other headaches
• Subject has received botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck within 4 months prior to screening.
• Have any clinically significant concurrent medical condition
• Receipt of any monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial)
• Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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665 participants in 5 patient groups, including a placebo group

ALD403 Dose Level 1

Experimental group

Description:

ALD403 Dose Level 1 (IV)

Treatment:

Biological: ALD403

ALD403 Dose Level 2

Experimental group

Description:

ALD403 Dose Level 2 (IV)

Treatment:

Biological: ALD403

ALD403 Dose Level 3

Experimental group

Description:

ALD403 Dose Level 3 (IV)

Treatment:

Biological: ALD403

ALD403 Dose Level 4

Experimental group

Description:

ALD403 Dose Level 4 (IV)

Treatment:

Biological: ALD403

Placebo

Placebo Comparator group

Description:

Placebo (IV)

Treatment:

Biological: Placebo