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Completed

NCT Number: NCT02275117

A Multicenter Assessment of ALD403 in Chronic Migraine

The purpose of this study is to assess ALD403 in the prevention of migraine headache in chronic migraineurs.

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALD403

Biological

Other names: Eptinezumab-jjmr, Vyepti

Placebo

Biological

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alder Biopharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 27, 2014
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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