A Multicenter Assessment of ALD403 in Frequent Episodic Migraine (PROMISE 1)

Alder Biopharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Migraine Disorders

Treatments: Drug: ALD403; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02559895

ALD403-CLIN-006

Details and patient eligibility

About

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

Enrollment: 898 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1)

• History of migraine ≥ 12 months with

  • ≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) in each 28 day period in the 3 months prior to screening
  • During the 28 days following the screening visit, the subject experiences ≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) as recorded in the eDiary

• No use of any botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck 4 months prior to screening and during the 28 day period prior to randomization

• Headache eDiary was completed on at least 25 of the 28 days prior to randomization

Exclusion criteria

• Confounding pain syndromes, e.g. fibromyalgia, 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- II, 2004 Section 1), 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
• 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: Quadruple Blind

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898 participants in 4 patient groups, including a placebo group

ALD403 Dose Level 1

Experimental group

Description:

ALD403 Dose Level 1 (IV)

Treatment:

Drug: ALD403

ALD403 Dose Level 2

Experimental group

Description:

ALD403 Dose Level 2 (IV)

Treatment:

Drug: ALD403

ALD403 Dose Level 3

Experimental group

Description:

ALD403 Dose Level 3 (IV)

Treatment:

Drug: ALD403

Placebo

Placebo Comparator group

Description:

Placebo (IV)

Treatment:

Drug: Placebo