A Multicenter Assessment of ALD403 in Frequent Episodic Migraine

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02559895
• Date of registration: 22/09/2015
• Prospective Registration: No
• Primary sponsor: Alder Biopharmaceuticals, Inc.
• Public title: A Multicenter Assessment of ALD403 in Frequent Episodic Migraine PROMISE 1
• Scientific title: A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Frequent Episodic Migraines
• Date of first enrolment: September 2015
• Target sample size: 898
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02559895
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Georgia, United States

Contacts

• Name: Tim Whitaker, MD
• Affiliation: Alder Biopharmaceuticals, Inc.

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Migraine Disorders

Intervention(s)

Drug: ALD403

Drug: Placebo

Primary Outcome(s)

Change From Baseline in Monthly Migraine Days (Weeks 1-12) [Time Frame: Week 1-12]

Secondary Outcome(s)

Change From Baseline in Acute Migraine Medication Days (Weeks 1-12) [Time Frame: Week 1-12]

Change From Baseline in Monthly Headache Hours, Weeks 1-12 [Time Frame: Week 1-12]

Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication [Time Frame: Week 1-12]

Health Related Quality of Life (EQ-5D-5L) at Week 12 [Time Frame: Week 12]

100% Headache Responder Rate [Time Frame: Week 1-12]

100% Migraine Responder Rate [Time Frame: Week 1-12]

Change From Baseline in Monthly Headache Days (Weeks 1-12) [Time Frame: Week 1-12]

Change From Baseline in Monthly Migraine Hours (Weeks 1-12) [Time Frame: Week 1-12]

Percent of Headaches With Severe Intensity [Time Frame: Week 1-12]

Percentage of Participants With a Migraine on the Day After Dosing [Time Frame: 1 day]

50% Migraine Responder Rate [Time Frame: Week 1-12]

75% Migraine Responder Rate [Time Frame: Week 1-12]

Change From Baseline in Average Daily Migraine Prevalence to Week 4 [Time Frame: Baseline to Week 4]

Percent of Migraines With Severe Intensity [Time Frame: Week 1-12]

75% Migraine Responder Rate [Time Frame: Week 1-4]

Change in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score [Time Frame: Baseline to Week 12]

75% Headache Responder Rate [Time Frame: Week 1-12]

Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication [Time Frame: Week 1-12]

50% Headache Responder Rate [Time Frame: Week 1-12]

Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores [Time Frame: Baseline to Week 12]

Secondary ID(s)

ALD403-CLIN-006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/05/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02559895