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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.
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):

Study Description
Brief Summary:
The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of migraine headache in chronic migraineurs.

Condition or disease Intervention/treatment Phase
Migraine Disorders Biological: ALD403 (Eptinezumab) Biological: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : November 2016
Estimated Primary Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ALD403 (Eptinezumab) Dose Level 1
ALD403 (Eptinezumab) Dose Level 1 (IV)
Biological: ALD403 (Eptinezumab)
Experimental: ALD403 (Eptinezumab) Dose Level 2
ALD403 (Eptinezumab) Dose Level 2 (IV)
Biological: ALD403 (Eptinezumab)
Placebo Comparator: Placebo
Placebo (IV)
Biological: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Change in frequency of migraine days [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Responder rate [ Time Frame: 4 weeks ]
  2. Responder rate [ Time Frame: 12 weeks ]
  3. Laboratory variables, ECG and adverse events [ Time Frame: 36 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974153


  Show 145 Study Locations
Sponsors and Collaborators
Alder Biopharmaceuticals, Inc.
More Information

Responsible Party: Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02974153     History of Changes
Other Study ID Numbers: ALD403-CLIN-011
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases