A Multicenter Assessment of ALD403 in Chronic Migraine

NCT02275117 | Completed Phase 2 Results

• 1 other identifier: ALD403-CLIN-005
• Study Type: interventional
• Target: 665
• Locations: 4 countries
• Sites: 92

Brief Summary

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

Conditions

Migraine Disorders

Keywords

Migraine Disorders; ALD403

Outcome Measures

Primary Outcomes (1)

• 75% Migraine Responder Rate

  Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.

  12 Weeks

Secondary Outcomes (19)

• 50% Migraine Responder Rate

  Weeks 1-12

• 50% Headache Responder Rate

  Weeks 1-12

• 100% Headache Responder Rate

  Weeks 1-12

• 100% Migraine Responder Rate

  Weeks 1-12

• The Change From Baseline in Monthly Headache Days, Weeks 1-12

  Weeks 1-12

Study Arms (5)

ALD403 Dose Level 1

EXPERIMENTAL

ALD403 Dose Level 1 (IV)

Biological: ALD403

ALD403 Dose Level 2

EXPERIMENTAL

ALD403 Dose Level 2 (IV)

Biological: ALD403

ALD403 Dose Level 3

EXPERIMENTAL

ALD403 Dose Level 3 (IV)

Biological: ALD403

ALD403 Dose Level 4

EXPERIMENTAL

ALD403 Dose Level 4 (IV)

Biological: ALD403

Placebo

PLACEBO COMPARATOR

Placebo (IV)

Biological: Placebo

Interventions

ALD403 BIOLOGICAL

Also known as: Eptinezumab-jjmr, Vyepti

ALD403 Dose Level 1; ALD403 Dose Level 2; ALD403 Dose Level 3; ALD403 Dose Level 4

Placebo BIOLOGICAL

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alder Biopharmaceuticals, Inc.: lead

Study Sites (92)

Research Site

Huntsville, Alabama, 35801, United States

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Mobile, Alabama, 36608, United States

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Phoenix, Arizona, 85027, United States

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Scottsdale, Arizona, 85259, United States

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Hot Springs, Arkansas, 71901, United States

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Little Rock, Arkansas, 72211, United States

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Anaheim, California, 92801, United States

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Encino, California, 91436, United States

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Long Beach, California, 90806, United States

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Los Angeles, California, 90036, United States

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Oakland, California, 94612, United States

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San Diego, California, 92108, United States

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San Francisco, California, 94102, United States

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Santa Monica, California, 90404, United States

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Stanford, California, 94305, United States

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Ventura, California, 93003, United States

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Colorado Springs, Colorado, 80918, United States

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Denver, Colorado, 80210, United States

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Stamford, Connecticut, 06905, United States

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Waterbury, Connecticut, 06708, United States

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Gainesville, Florida, 32607, United States

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Hallandale, Florida, 33009, United States

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Jacksonville, Florida, 32256, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33173, United States

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North Miami, Florida, 33161, United States

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Orlando, Florida, 32801, United States

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Orlando, Florida, 32806, United States

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Tampa, Florida, 33606, United States

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Atlanta, Georgia, 30022, United States

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Atlanta, Georgia, 30342, United States

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Chicago, Illinois, 60607, United States

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Chicago, Illinois, 60640, United States

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Evansville, Illinois, 47714, United States

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Normal, Illinois, 61761, United States

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Prairie Village, Kansas, 66206, United States

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Wichita, Kansas, 67207, United States

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Louisville, Kentucky, 40207, United States

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New Orleans, Louisiana, 70115, United States

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Shreveport, Louisiana, 71105, United States

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Boston, Massachusetts, 21310, United States

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Brockton, Massachusetts, 02301, United States

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New Bedford, Massachusetts, 02740, United States

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Watertown, Massachusetts, 02472, United States

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Ann Arbor, Michigan, 48104, United States

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Springfield, Missouri, 65807, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68134, United States

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Princeton, New Jersey, 08540, United States

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Albuquerque, New Mexico, 87102, United States

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Albany, New York, 12208, United States

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Amherst, New York, 14226, United States

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Brooklyn, New York, 11235, United States

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Endwell, New York, 13760, United States

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New York, New York, 10019, United States

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Rochester, New York, 14609, United States

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The Bronx, New York, 10461, United States

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Cary, North Carolina, 27518, United States

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Winston-Salem, North Carolina, 27103, United States

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Canton, Ohio, 44718, United States

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Cincinnati, Ohio, 45255, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43213, United States

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Dayton, Ohio, 45424, United States

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Oklahoma City, Oklahoma, 73116, United States

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Portland, Oregon, 97239, United States

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Philadelphia, Pennsylvania, 19107, United States

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Willow Grove, Pennsylvania, 19090, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Chattanooga, Tennessee, 37421, United States

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Memphis, Tennessee, 38119, United States

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Austin, Texas, 78705, United States

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Dallas, Texas, 75231, United States

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Fort Worth, Texas, 76104, United States

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Houston, Texas, 77058, United States

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Orem, Utah, 84058, United States

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Salt Lake City, Utah, 84109, United States

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Richmond, Virginia, 23226, United States

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Virginia Beach, Virginia, 23454, United States

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Bellevue, Washington, 98007, United States

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Seattle, Washington, 98105, United States

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Tacoma, Washington, 98405, United States

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Sydney, New South Wales, 2031, Australia

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Melbourne, Victoria, 3004, Australia

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Melbourne, Victoria, 3050, Australia

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Perth, Western Australia, 6009, Australia

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Tbilisi, 0112, Georgia

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Tbilisi, 0160, Georgia

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Tbilisi, 0186, Georgia

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Auckland, 8963, New Zealand

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Christchurch, 2856, New Zealand

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Hamilton, 3204, New Zealand

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Related Publications (3)

• Smith TR, Spierings ELH, Cady R, Hirman J, Ettrup A, Shen V. Cardiovascular outcomes in adults with migraine treated with eptinezumab for migraine prevention: pooled data from four randomized, double-blind, placebo-controlled studies. J Headache Pain. 2021 Nov 25;22(1):143. doi: 10.1186/s10194-021-01360-1.

  PMID: 34823467 DERIVED

• Smith TR, Spierings ELH, Cady R, Hirman J, Schaeffler B, Shen V, Sperling B, Brevig T, Josiassen MK, Brunner E, Honeywell L, Mehta L. Safety and tolerability of eptinezumab in patients with migraine: a pooled analysis of 5 clinical trials. J Headache Pain. 2021 Mar 30;22(1):16. doi: 10.1186/s10194-021-01227-5.

  PMID: 33781209 DERIVED

• Dodick DW, Lipton RB, Silberstein S, Goadsby PJ, Biondi D, Hirman J, Cady R, Smith J. Eptinezumab for prevention of chronic migraine: A randomized phase 2b clinical trial. Cephalalgia. 2019 Aug;39(9):1075-1085. doi: 10.1177/0333102419858355. Epub 2019 Jun 24.

  PMID: 31234642 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Migraine Disorders

Interventions

eptinezumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Email contact via
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@Lundbeck.com

+4536301311

Study Officials

• Jeff TL Smith, MD

  Alder Biopharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 27, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 8, 2020
• Results First Posted: March 30, 2020

Record last verified: 2020-03

Locations

AU (4); NZ (3); GE (3); US (82)