Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine (PROMISE 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02974153
Recruitment Status : Completed
First Posted : November 28, 2016
Last Update Posted : September 19, 2018
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.

November 23, 2016
November 28, 2016
September 19, 2018
November 2016
November 2017   (Final data collection date for primary outcome measure)
Change in frequency of migraine days [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT02974153 on Archive Site
  • Responder rate [ Time Frame: 4 weeks ]
  • Responder rate [ Time Frame: 12 weeks ]
  • Laboratory variables, ECG and adverse events [ Time Frame: 36 weeks ]
Same as current
Not Provided
Not Provided
Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine
A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Chronic Migraine
The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of migraine headache in chronic migraineurs.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Migraine Disorders
  • Biological: ALD403 (Eptinezumab)
  • Biological: Placebo
  • Experimental: ALD403 (Eptinezumab) Dose Level 1
    ALD403 (Eptinezumab) Dose Level 1 (IV)
    Intervention: Biological: ALD403 (Eptinezumab)
  • Experimental: ALD403 (Eptinezumab) Dose Level 2
    ALD403 (Eptinezumab) Dose Level 2 (IV)
    Intervention: Biological: ALD403 (Eptinezumab)
  • Placebo Comparator: Placebo
    Placebo (IV)
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2018
November 2017   (Final data collection date for primary outcome measure)

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.
  • During the 28 day screening period, subjects must adequately complete the headache eDiary and must have headaches occurring on ≥ 15 to ≤ 26 days of which at least 8 must be migraine days.
  • Headache eDiary was completed on at least 24 of the 28 days prior to randomization.

Exclusion Criteria:

  • 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.
  • Any use of botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections within 4 months prior to screening and during the screening period.
  • 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.
  • Receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening.
  • Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czechia,   Denmark,   Georgia,   Germany,   Hungary,   Italy,   Russian Federation,   Slovakia,   Spain,   Ukraine,   United Kingdom,   United States
Not Provided
Not Provided
Alder Biopharmaceuticals, Inc.
Alder Biopharmaceuticals, Inc.
Not Provided
Not Provided
Alder Biopharmaceuticals, Inc.
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP