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

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ClinicalTrials.gov Identifier: NCT02974153
Recruitment Status : Active, not recruiting
First Posted : November 28, 2016
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.

November 23, 2016
November 28, 2016
November 14, 2017
November 2016
June 2018   (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 ClinicalTrials.gov 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
Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1050
Same as current
Not Provided
June 2018   (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)
No
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
 
 
NCT02974153
ALD403-CLIN-011
Yes
Not Provided
Not Provided
Alder Biopharmaceuticals, Inc.
Alder Biopharmaceuticals, Inc.
Not Provided
Not Provided
Alder Biopharmaceuticals, Inc.
November 2017

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