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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 : Completed
First Posted : November 28, 2016
Results First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1121 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
Actual Study Start Date : November 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: ALD403 (Eptinezumab) Dose Level 1
ALD403 (Eptinezumab) Dose Level 1 (IV)
 Biological: ALD403 (Eptinezumab)
Other Names:
  • Eptinezumab-jjmr
  • Vyepti
Experimental: ALD403 (Eptinezumab) Dose Level 2
ALD403 (Eptinezumab) Dose Level 2 (IV)
 Biological: ALD403 (Eptinezumab)
Other Names:
  • Eptinezumab-jjmr
  • Vyepti
Placebo Comparator: Placebo
Placebo (IV)
 Biological: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Monthly Migraine Days [ Time Frame: Week 1-12 ]
    Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12


Secondary Outcome Measures :
  1. 75% Migraine Responder Rate [ Time Frame: Week 1-12 ]
    Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.

  2. 75% Migraine Responder Rate - 4 Week [ Time Frame: Week 1-4 ]
    Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 4, as compared with baseline.

  3. 50% Migraine Responder Rate [ Time Frame: Week 1-12 ]
    Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline.

  4. Percentage of Participants With a Migraine on the Day After Dosing [ Time Frame: Day 1 ]
    The percentage of participants with a migraine on the day after dosing, where Day 0 is treatment Day and Day 1 is the day after dosing.

  5. Change in Monthly Acute Medication Days [ Time Frame: Week 1-12 ]
    An acute medication migraine day was a day with any triptan or ergotamine use as recorded in the eDiary.

  6. Change From Baseline of Headache Impact Test (HIT-6) Score [ Time Frame: Baseline to Week 12 ]
    The HIT-6 measures the impact of headache on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact).

  7. Change in Migraine Prevalence From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
    The avarage change in percentage of participants with a migraine on any given day during baseline and the equivalent avarage rate over Weeks 1-4.

  8. 75% Headache Responder Rate [ Time Frame: Week 1-12 ]
    Participants with an average reduction in headache days of at least 75% over Weeks 1 to 12, as compared with baseline.

  9. 50% Headache Responder Rate [ Time Frame: Week 1-12 ]
    Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline.

  10. 100% Migraine Responder Rate [ Time Frame: Week 1-12 ]
    For each 4-week period the 100% response is determined, and the result for a participant is the average rate across Weeks 1-12. If a participant has one 4-week period out of 3 with 100% response, they are included as 33%.

  11. 100% Headache Responder Rate [ Time Frame: Week 1-12 ]
    For each 4-week period the 100% response is determined, and the result for a participant is the average rate across Weeks 1-12. If a participant has one 4-week period out of 3 with 100% response, they are included as 33%.

  12. Change From Baseline in Monthly Migraine Days (Weeks 13-24) [ Time Frame: Week 13-24 ]
    Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 13-24.

  13. Change From Baseline in Monthly Headache Days (Weeks 1-12) [ Time Frame: Week 1-12 ]
    Monthly headache days are summarized in 28-day intervals, and averaged across Weeks 1-12.

  14. Time to First Migraine After Dosing [ Time Frame: 32 weeks ]
    The time to first migraine after dosing based upon the migraine data entered into the eDiary

  15. Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication [ Time Frame: Week 1-12 ]
    The percentage of migraines with acute medication usage. Participants with no migraine will be included with a rate of zero.

  16. Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication [ Time Frame: Week 1-12 ]
    The percentage of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.

  17. Percent Change in Frequency of Migraine Days - Week 1-12 [ Time Frame: Week 1-12 ]
    The percent change in frequency of migraine days from Weeks 1-12 was calculated as the number of migraine days within 4-week intervals that were then averaged up to Week 12. The difference of this estimate from baseline was calculated as the change from baseline in the frequency of migraine days over Weeks 1-12.

  18. Percent Change in Frequency of Headache Days - Week 1-12 [ Time Frame: Week 1-12 ]
    The percent change in frequency of headache days from Weeks 1-12 was calculated as the number of headache days within 4-week intervals that were then averaged up to Week 12. The difference of this estimate from baseline was calculated as the change from baseline in the frequency of headache days over Weeks 1-12.

  19. Change From Baseline in Percentage of Severe Migraines [ Time Frame: Week 1-12 ]
    The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12.

  20. Change From Baseline in Percentage of Severe Headache [ Time Frame: Week 1-12 ]
    The change from baseline in percentage of headaches that are classified as severe over Weeks 1-12.

  21. Change From Baseline in Monthly Migraine Hours, Weeks 1-12 [ Time Frame: Week 1-12 ]
    Migraine hours are the sum of migraines within 4 week intervals, and the average 4 week duration within 12 weeks.

  22. Change From Baseline in Monthly Headache Hours, Weeks 1-12 [ Time Frame: Week 1-12 ]
    Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals.

  23. Duration of Migraine-Free Intervals [ Time Frame: 32 weeks ]
    The number of participants with migraine-free intervals starting within the first 2 weeks of treatment. The longest migraine free interval for each participant is recorded.

  24. Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores [ Time Frame: Baseline to Week 12 ]
    The SF-36 is a health survey containing 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks. All scales are on a range of 0 to 100, with 0 being the worst and 100 being the best. Scales are reported separately. Increases from baseline indicate improvement.

  25. Patient Global Impression of Change (PGIC) at Week 12 [ Time Frame: Week 12 ]
    The PGIC includes a single question concerning the participant's impression of the change in their disease status since the start of the study. Seven responses are possible: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.

  26. Health Related Quality of Life (EQ-5D-5L) at Week 12 [ Time Frame: Week 12 ]
    The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of 5 dimensions/questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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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


Locations
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Sponsors and Collaborators
Alder Biopharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Alder Biopharmaceuticals, Inc.:
Study Protocol  [PDF] August 31, 2017
Statistical Analysis Plan  [PDF] November 8, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02974153    
Other Study ID Numbers: ALD403-CLIN-011
First Posted: November 28, 2016    Key Record Dates
Results First Posted: June 9, 2020
Last Update Posted: June 9, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases