Clinical trial NCT02275117: A Multicenter Assessment of ALD403 in Chronic Migraine
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine Disorders
Keywords: Migraine Disorders
ALD403
Lead sponsor: Alder Biopharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-27
Enrollment: 665
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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

Primary outcomes:
measure: 75% Migraine Responder Rate
timeFrame: 12 Weeks
Secondary outcomes:
measure: 50% Migraine Responder Rate
timeFrame: Weeks 1-12
measure: 50% Headache Responder Rate
timeFrame: Weeks 1-12
measure: 100% Headache Responder Rate
timeFrame: Weeks 1-12
measure: 100% Migraine Responder Rate
timeFrame: Weeks 1-12
measure: The Change From Baseline in Monthly Headache Days, Weeks 1-12
timeFrame: Weeks 1-12
measure: The Change From Baseline in Monthly Migraine Days, Weeks 1-12
timeFrame: Weeks 1-12
measure: Change From Baseline in Percentage of Severe Migraines
timeFrame: Weeks 1-12
measure: Change From Baseline in Percentage of Severe Headaches
timeFrame: Weeks 9-12
measure: The Change From Baseline to Week 12 in HIT-6 Total Score
timeFrame: Baseline to 12
measure: Percent Change From Baseline in Headache Days
timeFrame: Weeks 1-12
measure: Percent Change From Baseline in Migraine Days
timeFrame: Weeks 1-12
measure: Time to First Migraine After Dosing
timeFrame: Baseline to Week 49 (End of Study)
measure: Change From Baseline in Monthly Migraine Attacks, Weeks 1-12
timeFrame: Weeks 1-12
measure: Change From Baseline in Monthly Headache Episodes, Weeks 1-12
timeFrame: Weeks 1-12
measure: Change From Baseline in Monthly Migraine Hours, Weeks 1-12
timeFrame: Weeks 1-12
measure: Change From Baseline in Monthly Headache Hours, Weeks 1-12
timeFrame: Weeks 1-12
measure: Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication
timeFrame: Weeks 9-12
measure: Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication
timeFrame: Weeks 9-12
measure: Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Hot Springs
country: United States
facility: Research Site
state: Arkansas
city: Little Rock
country: United States
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state: Arkansas
city: Anaheim
country: United States
facility: Research Site
state: California
city: Encino
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Reserach Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Oakland
country: United States
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state: California
city: San Diego
country: United States
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state: California
city: San Francisco
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state: California
city: Santa Monica
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city: Stanford
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state: California
city: Ventura
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state: California
city: Colorado Springs
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state: Colorado
city: Denver
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state: Colorado
city: Stamford
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state: Connecticut
city: Waterbury
country: United States
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state: Connecticut
city: Gainesville
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state: Florida
city: Hallandale Beach
country: United States
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state: Florida
city: Jacksonville
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state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
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state: Florida
city: North Miami
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state: Florida
city: Orlando
country: United States
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state: Florida
city: Orlando
country: United States
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state: Florida
city: Tampa
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state: Florida
city: Atlanta
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state: Georgia
city: Atlanta
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state: Georgia
city: Chicago
country: United States
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state: Illinois
city: Chicago
country: United States
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state: Illinois
city: Evansville
country: United States
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state: Illinois
city: Normal
country: United States
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state: Illinois
city: Prairie Village
country: United States
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state: Kansas
city: Wichita
country: United States
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state: Kansas
city: Louisville
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state: Kentucky
city: New Orleans
country: United States
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state: Louisiana
city: Shreveport
country: United States
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state: Louisiana
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Brockton
country: United States
facility: Research Site
state: Massachusetts
city: New Bedford
country: United States
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state: Massachusetts
city: Watertown
country: United States
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state: Massachusetts
city: Ann Arbor
country: United States
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state: Michigan
city: Saint Louis
country: United States
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state: Missouri
city: Springfield
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state: Missouri
city: Omaha
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state: Nebraska
city: Princeton
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state: New Jersey
city: Albuquerque
country: United States
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state: New Mexico
city: Albany
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state: New York
city: Amherst
country: United States
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state: New York
city: Bronx
country: United States
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state: New York
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Endwell
country: United States
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state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Cary
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Canton
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
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state: Oklahoma
city: Portland
country: United States
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state: Oregon
city: Philadelphia
country: United States
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state: Pennsylvania
city: Willow Grove
country: United States
facility: Research Site
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Research Site
state: South Carolina
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Fort Worth
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Orem
country: United States
facility: Research Site
state: Utah
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Virginia Beach
country: United States
facility: Research Site
state: Virginia
city: Bellevue
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Sydney
country: Australia
facility: Research Site
state: New South Wales
city: Melbourne
country: Australia
facility: Research Site
state: Victoria
city: Melbourne
country: Australia
facility: Research Site
state: Victoria
city: Perth
country: Australia
facility: Research Site
state: Western Australia
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Auckland
country: New Zealand
facility: Research Site
city: Christchurch
country: New Zealand
facility: Research Site
city: Hamilton
country: New Zealand
facility: Research Site
Study officials:
affiliation: Alder Biopharmaceuticals, Inc.
name: Jeff TL Smith, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.