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A Multicenter Assessment of ALD403 in Chronic Migraine

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ClinicalTrials.gov Identifier: NCT02275117
Recruitment Status : Completed
First Posted : October 27, 2014
Results First Posted : March 30, 2020
Last Update Posted : April 8, 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 chronic migraineurs.

Condition or disease Intervention/treatment Phase
Migraine Disorders Biological: ALD403 Biological: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 665 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Phase 2 Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALD403 Administered Intravenously in Patients With Chronic Migraine
Study Start Date : October 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : November 2016

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)
 Biological: ALD403
Other Names:
  • Eptinezumab-jjmr
  • Vyepti
Experimental: ALD403 Dose Level 2
ALD403 Dose Level 2 (IV)
 Biological: ALD403
Other Names:
  • Eptinezumab-jjmr
  • Vyepti
Experimental: ALD403 Dose Level 3
ALD403 Dose Level 3 (IV)
 Biological: ALD403
Other Names:
  • Eptinezumab-jjmr
  • Vyepti
Experimental: ALD403 Dose Level 4
ALD403 Dose Level 4 (IV)
 Biological: ALD403
Other Names:
  • Eptinezumab-jjmr
  • Vyepti
Placebo Comparator: Placebo
Placebo (IV)
 Biological: Placebo


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


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

  2. 50% Headache Responder Rate [ Time Frame: Weeks 1-12 ]
    Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline

  3. 100% Headache Responder Rate [ Time Frame: Weeks 1-12 ]
    Participants with an average reduction in headache days of at least 100% over Weeks 1 to 12, as compared with baseline

  4. 100% Migraine Responder Rate [ Time Frame: Weeks 1-12 ]
    Participants with an average reduction in migraine days of at least 100% over Weeks 1 to 12, as compared with baseline

  5. The Change From Baseline in Monthly Headache Days, Weeks 1-12 [ Time Frame: Weeks 1-12 ]
    Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.

  6. The Change From Baseline in Monthly Migraine Days, Weeks 1-12 [ Time Frame: Weeks 1-12 ]
    Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.

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

  8. Change From Baseline in Percentage of Severe Headaches [ Time Frame: Weeks 9-12 ]
    The change from baseline in percentage of headaches that are classified as severe over Weeks 9-12

  9. The Change From Baseline to Week 12 in HIT-6 Total Score [ Time Frame: Baseline to 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). A score of 60 or above is labeled as "severe".

  10. Percent Change From Baseline in Headache Days [ Time Frame: Weeks 1-12 ]
    Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.

  11. Percent Change From Baseline in Migraine Days [ Time Frame: Weeks 1-12 ]
    Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.

  12. Time to First Migraine After Dosing [ Time Frame: Baseline to Week 49 (End of Study) ]
    The median number of days after dosing a participant had the next migraine using the eDiary as the recall method

  13. Change From Baseline in Monthly Migraine Attacks, Weeks 1-12 [ Time Frame: Weeks 1-12 ]
    The number of monthly migraine attacks summarized over Weeks 1-12. A migraine attack is defined as 1 continuously recorded migraine. One attack may result in multiple migraine days

  14. Change From Baseline in Monthly Headache Episodes, Weeks 1-12 [ Time Frame: Weeks 1-12 ]
    The number of monthly headache episodes as summarized over Weeks 1-12. A headache episode is defined as 1 continuously recorded headache. One episode may result in multiple headache days

  15. Change From Baseline in Monthly Migraine Hours, Weeks 1-12 [ Time Frame: Weeks 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.

  16. Change From Baseline in Monthly Headache Hours, Weeks 1-12 [ Time Frame: Weeks 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.

  17. Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication [ Time Frame: Weeks 9-12 ]
    The percent of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero.

  18. Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication [ Time Frame: Weeks 9-12 ]
    The percent of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.

  19. Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12 [ 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 (range: 0=worst to 100=best). Increases from baseline indicate improvement.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of migraine at ≤ 35 years of age with history of chronic migraine ≥ 1 year
  • During the 28 day screening period, must have ≥ 15 headache days of which ≥ 8 days were assessed as migraine days with at least 5 migraine attacks as recorded in the eDiary
  • Headache eDiary was completed on at least 22 of the 28 days prior to randomization

Exclusion Criteria:

  • Confounding pain syndromes (e.g. fibromyalgia, chronic low back pain, 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-III beta version, 2013), 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
  • Subject has received botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck within 4 months prior to screening.
  • 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): NCT02275117


Locations
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Sponsors and Collaborators
Alder Biopharmaceuticals, Inc.
Investigators
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Study Director: Jeff TL Smith, MD Alder Biopharmaceuticals, Inc.
More Information
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Additional Information:

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

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Responsible Party: Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02275117    
Other Study ID Numbers: ALD403-CLIN-005
First Posted: October 27, 2014    Key Record Dates
Results First Posted: March 30, 2020
Last Update Posted: April 8, 2020
Last Verified: March 2020
Keywords provided by Alder Biopharmaceuticals, Inc.:
Migraine Disorders
ALD403
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases