A Multicenter Assessment of ALD403 in Frequent Episodic Migraine

NCT02559895 | Completed Phase 3 Results DMC

• 1 other identifier: ALD403-CLIN-006
• Study Type: interventional
• Target: 898
• Locations: 2 countries
• Sites: 87

Brief Summary

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

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Monthly Migraine Days (Weeks 1-12)

  Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12

  Week 1-12

Secondary Outcomes (20)

• 75% Migraine Responder Rate

  Week 1-12

• 75% Migraine Responder Rate

  Week 1-4

• 50% Migraine Responder Rate

  Week 1-12

• Percentage of Participants With a Migraine on the Day After Dosing

  1 day

• 75% Headache Responder Rate

  Week 1-12

Study Arms (4)

ALD403 Dose Level 1

EXPERIMENTAL

ALD403 Dose Level 1 (IV)

Drug: ALD403

ALD403 Dose Level 2

EXPERIMENTAL

ALD403 Dose Level 2 (IV)

Drug: ALD403

ALD403 Dose Level 3

EXPERIMENTAL

ALD403 Dose Level 3 (IV)

Drug: ALD403

Placebo

PLACEBO COMPARATOR

Placebo (IV)

Drug: Placebo

Interventions

ALD403 DRUG

Also known as: Eptinezumab-jjmr, Vyepti

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

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alder Biopharmaceuticals, Inc.: lead

Study Sites (87)

Research Site

Birmingham, Alabama, 35216, United States

Location

Research Site

Phoenix, Arizona, 85013, United States

Location

Research Site

Tucson, Arizona, 85712, United States

Location

Research Site

Little Rock, Arkansas, 72205, United States

Location

Research Site

Anaheim, California, 92801, United States

Location

Research Site

Fresno, California, 93702, United States

Location

Research Site

Fullerton, California, 92835, United States

Location

Research Site

Long Beach, California, 90806, United States

Location

Research Site

Montclair, California, 91763, United States

Location

Research Site

Oceanside, California, 92056, United States

Location

Research Site

Redlands, California, 92374, United States

Location

Research Site

San Diego, California, 92103, United States

Location

Research Site

San Diego, California, 92108, United States

Location

Research Site

Santa Monica, California, 90404, United States

Location

Research Site

Sherman Oaks, California, 91403, United States

Location

Research Site

Colorado Springs, Colorado, 80918, United States

Location

Research Site

Fort Collins, Colorado, 80528, United States

Location

Research Site

Stamford, Connecticut, 06905, United States

Location

Research Site

Waterbury, Connecticut, 06708, United States

Location

Research Site

Bradenton, Florida, 34201, United States

Location

Research Site

DeLand, Florida, 32720, United States

Location

Research site

Fort Myers, Florida, 33912, United States

Location

Research Site

Hallandale, Florida, 33009, United States

Location

Research Site

Hialeah, Florida, 33012, United States

Location

Research Site

Maitland, Florida, 32751, United States

Location

Research Site

Miami, Florida, 33143, United States

Location

Research Site

Miami, Florida, 33155, United States

Location

Research Site

Miami, Florida, 33173, United States

Location

Research Site

Naples, Florida, 34102, United States

Location

Research Site

Orlando, Florida, 32801, United States

Location

Research Site

Sunrise, Florida, 33351, United States

Location

Research Site

Winter Haven, Florida, 33880, United States

Location

Research Site

Atlanta, Georgia, 30331, United States

Location

Research Site

Atlanta, Georgia, 30342, United States

Location

Research Site

Stockbridge, Georgia, 30281, United States

Location

Research Site

Chicago, Illinois, 60607, United States

Location

Research Site

Lisle, Illinois, 60532, United States

Location

Research Site

Prairie Village, Kansas, 66206, United States

Location

Research Site

Lexington, Kentucky, 40509, United States

Location

Research Site

Owensboro, Kentucky, 42303, United States

Location

Research Site

New Orleans, Louisiana, 70115, United States

Location

Research Site

Boston, Massachusetts, 02131, United States

Location

Research Site

North Attleboro, Massachusetts, 02760, United States

Location

Research Site

Springfield, Massachusetts, 01104, United States

Location

Research Site

Watertown, Massachusetts, 02472, United States

Location

Research Site

Ann Arbor, Michigan, 48104, United States

Location

Research Site

Farmington Hills, Michigan, 48334, United States

Location

Research Site

Jackson, Michigan, 49201, United States

Location

Research Site

Minneapolis, Minnesota, 55402, United States

Location

Research Site

Flowood, Mississippi, 39232, United States

Location

Research Site

Springfield, Missouri, 65807, United States

Location

Research Site

St Louis, Missouri, 63141, United States

Location

Research Site

Las Vegas, Nevada, 89119, United States

Location

Research Site

Reno, Nevada, 89502, United States

Location

Research Site

Albuquerque, New Mexico, 87102, United States

Location

Research Site

Brooklyn, New York, 11213, United States

Location

Research Site

Brooklyn, New York, 11229, United States

Location

Research Site

Hartsdale, New York, 10530, United States

Location

Research Site

Rochester, New York, 14609, United States

Location

Research Site

Staten Island, New York, 10312, United States

Location

Research Site

Durham, North Carolina, 27713, United States

Location

Research Site

Greensboro, North Carolina, 27405, United States

Location

Research Site

High Point, North Carolina, 27265, United States

Location

Research Site

Wilmington, North Carolina, 28401, United States

Location

Research Site

Dayton, Ohio, 45424, United States

Location

Research Site

Edmond, Oklahoma, 73034, United States

Location

Research Site

Norman, Oklahoma, 73069, United States

Location

Research Site

Oklahoma City, Oklahoma, 73112, United States

Location

Research Site

Portland, Oregon, 97210, United States

Location

Research Site

Allentown, Pennsylvania, 18104, United States

Location

Research Site

Smithfield, Pennsylvania, 15478, United States

Location

Research Site

Anderson, South Carolina, 29621, United States

Location

Research Site

Chattanooga, Tennessee, 37404, United States

Location

Research Site

Chattanooga, Tennessee, 37421, United States

Location

Research Site

Kingsport, Tennessee, 37660, United States

Location

Research Site

Memphis, Tennessee, 38119, United States

Location

Research Site

Austin, Texas, 78745, United States

Location

Research Site

Dallas, Texas, 75231, United States

Location

Research Site

Houston, Texas, 77074, United States

Location

Research Site

Houston, Texas, 77081, United States

Location

Research Site

Richmond, Virginia, 23294, United States

Location

Research Site

Virginia Beach, Virginia, 23454, United States

Location

Research Site

Bellevue, Washington, 98007, United States

Location

Research Site

Tbilisi, 0112, Georgia

Location

Research Site

Tbilisi, 0160, Georgia

Location

Research Site

Tbilisi, 0179, Georgia

Location

Research Site

Tbilisi, 0186, Georgia

Location

Related Publications (9)

• Pozo-Rosich P, Dodick DW, Ettrup A, Hirman J, Cady R. Shift in diagnostic classification of migraine after initiation of preventive treatment with eptinezumab: post hoc analysis of the PROMISE studies. BMC Neurol. 2022 Oct 25;22(1):394. doi: 10.1186/s12883-022-02914-9.

  PMID: 36284281 DERIVED

• Apelian R, Boyle L, Hirman J, Asher D. Measuring dose-related efficacy of eptinezumab for migraine prevention: post hoc analysis of PROMISE-1 and PROMISE-2. J Headache Pain. 2022 Apr 18;23(1):48. doi: 10.1186/s10194-022-01418-8.

  PMID: 35436857 DERIVED

• Ashina M, McAllister P, Cady R, Hirman J, Ettrup A. Efficacy and safety of eptinezumab in patients with migraine and self-reported aura: Post hoc analysis of PROMISE-1 and PROMISE-2. Cephalalgia. 2022 Jul;42(8):696-704. doi: 10.1177/03331024221077646. Epub 2022 Mar 18.

  PMID: 35302389 DERIVED

• Martin V, Nagy AJ, Janelidze M, Giorgadze G, Hirman J, Cady R, Mehta L, Buse DC. Impact of Baseline Characteristics on the Efficacy and Safety of Eptinezumab in Patients With Migraine: Subgroup Analyses of PROMISE-1 and PROMISE-2. Clin Ther. 2022 Mar;44(3):389-402. doi: 10.1016/j.clinthera.2022.01.006. Epub 2022 Feb 5.

  PMID: 35131090 DERIVED

• Lipton RB, Charleston L 4th, Tassorelli C, Brevig T, Hirman J, Cady R. Patient-reported outcomes, health-related quality of life, and acute medication use in patients with a >/= 75% response to eptinezumab: subgroup pooled analysis of the PROMISE trials. J Headache Pain. 2022 Feb 7;23(1):23. doi: 10.1186/s10194-022-01386-z.

  PMID: 35130836 DERIVED

• 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

• Smith TR, Janelidze M, Chakhava G, Cady R, Hirman J, Allan B, Pederson S, Smith J, Schaeffler B. Eptinezumab for the Prevention of Episodic Migraine: Sustained Effect Through 1 Year of Treatment in the PROMISE-1 Study. Clin Ther. 2020 Dec;42(12):2254-2265.e3. doi: 10.1016/j.clinthera.2020.11.007. Epub 2020 Nov 27.

  PMID: 33250209 DERIVED

• Ashina M, Saper J, Cady R, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Smith J. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia. 2020 Mar;40(3):241-254. doi: 10.1177/0333102420905132. Epub 2020 Feb 19.

  PMID: 32075406 DERIVED

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

• Tim Whitaker, MD

  Alder Biopharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 25, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 14, 2020
• Results First Posted: May 14, 2020

Record last verified: 2020-05

Locations

US (83); GE (4)