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A Multicenter Assessment of ALD403 in Frequent Episodic Migraine (PROMISE 1)

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: NCT02559895
Recruitment Status : Completed
First Posted : September 25, 2015
Results First Posted : May 14, 2020
Last Update Posted : May 14, 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 ALD403 in the prevention of migraine headache in frequent episodic migraineurs.

Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: ALD403 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 898 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, Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Frequent Episodic Migraines
Study Start Date : September 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : December 2017

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 Dose Level 1
ALD403 Dose Level 1 (IV)
 Drug: ALD403
Other Names:
  • Eptinezumab-jjmr
  • Vyepti
Experimental: ALD403 Dose Level 2
ALD403 Dose Level 2 (IV)
 Drug: ALD403
Other Names:
  • Eptinezumab-jjmr
  • Vyepti
Experimental: ALD403 Dose Level 3
ALD403 Dose Level 3 (IV)
 Drug: ALD403
Other Names:
  • Eptinezumab-jjmr
  • Vyepti
Placebo Comparator: Placebo
Placebo (IV)
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Monthly Migraine Days (Weeks 1-12) [ 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 [ 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: 1 day ]
    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. 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.

  6. 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.

  7. 100% Migraine Responder Rate [ Time Frame: Week 1-12 ]
    Participants with a reduction in migraine days of 100% over Weeks 1 to 12, as compared with baseline

  8. 100% Headache Responder Rate [ Time Frame: Week 1-12 ]
    Participants with a reduction in headache days of 100% over Weeks 1 to 12, as compared with baseline.

  9. Change From Baseline in Acute Migraine Medication Days (Weeks 1-12) [ Time Frame: Week 1-12 ]
    The change in number of days with any triptan or ergotamine use as recorded in the eDiary.

  10. Change From Baseline in Average Daily Migraine Prevalence to Week 4 [ Time Frame: Baseline to Week 4 ]
    The change in the percentage of days where a participant has a migraine from baseline to Week 4.

  11. 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 migraines will be included with a rate of zero.

  12. 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.

  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. Percent of Headaches With Severe Intensity [ Time Frame: Week 1-12 ]
    Summary of percent of headaches with severe intensity over Weeks 1-12.

  15. Percent of Migraines With Severe Intensity [ Time Frame: Week 1-12 ]
    Summary of percent of migraines with severe intensity over Week 1-12.

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

  17. 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.

  18. 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.

  19. 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 dimension/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.

  20. Change in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score [ Time Frame: Baseline to Week 12 ]
    The ASC-12 includes 12 questions about the frequency of various allodynia symptoms in association with headache attacks. For individuals with more than one type of headache, questions are directed to the "most severe type of headache." Each item is measured in a Likert type scale option with response categories: "Does not apply to me", "never", "rarely", "less than half the time", and "half the time or more". ASC items were scored as 0 (i.e., never, rarely or does not apply to me), 1 (less than half the time), and 2 (half the time or more), yielding scores that ranged from 0 to 24. If a single item is missing, it is scored as a 0. If more than one item is missing the total score will be missing. The interpretation of the total score is, 0-2: none; 3-5: mild; 6-8: moderate; greater than or equal to 9: severe.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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): NCT02559895


Locations
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Sponsors and Collaborators
Alder Biopharmaceuticals, Inc.
Investigators
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Study Director: Tim Whitaker, MD Alder Biopharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Alder Biopharmaceuticals, Inc.:
Study Protocol  [PDF] April 24, 2017
Statistical Analysis Plan  [PDF] May 18, 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: NCT02559895    
Other Study ID Numbers: ALD403-CLIN-006
First Posted: September 25, 2015    Key Record Dates
Results First Posted: May 14, 2020
Last Update Posted: May 14, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases