Clinical trial NCT02559895: A Multicenter Assessment of ALD403 in Frequent Episodic Migraine
Official title: A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Frequent Episodic Migraines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Disorders
Lead sponsor: Alder Biopharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-25
Enrollment: 898
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_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 frequent episodic migraineurs.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Monthly Migraine Days (Weeks 1-12)
timeFrame: Week 1-12
Secondary outcomes:
measure: 75% Migraine Responder Rate
timeFrame: Week 1-12
measure: 75% Migraine Responder Rate
timeFrame: Week 1-4
measure: 50% Migraine Responder Rate
timeFrame: Week 1-12
measure: Percentage of Participants With a Migraine on the Day After Dosing
timeFrame: 1 day
measure: 75% Headache Responder Rate
timeFrame: Week 1-12
measure: 50% Headache Responder Rate
timeFrame: Week 1-12
measure: 100% Migraine Responder Rate
timeFrame: Week 1-12
measure: 100% Headache Responder Rate
timeFrame: Week 1-12
measure: Change From Baseline in Acute Migraine Medication Days (Weeks 1-12)
timeFrame: Week 1-12
measure: Change From Baseline in Average Daily Migraine Prevalence to Week 4
timeFrame: Baseline to Week 4
measure: Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication
timeFrame: Week 1-12
measure: Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication
timeFrame: Week 1-12
measure: Change From Baseline in Monthly Headache Days (Weeks 1-12)
timeFrame: Week 1-12
measure: Percent of Headaches With Severe Intensity
timeFrame: Week 1-12
measure: Percent of Migraines With Severe Intensity
timeFrame: Week 1-12
measure: Change From Baseline in Monthly Migraine Hours (Weeks 1-12)
timeFrame: Week 1-12
measure: Change From Baseline in Monthly Headache Hours, Weeks 1-12
timeFrame: Week 1-12
measure: Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores
timeFrame: Baseline to Week 12
measure: Health Related Quality of Life (EQ-5D-5L) at Week 12
timeFrame: Week 12
measure: Change in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Anaheim
country: United States
facility: Research Site
state: California
city: Fresno
country: United States
facility: Research Site
state: California
city: Fullerton
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Montclair
country: United States
facility: Research Site
state: California
city: Oceanside
country: United States
facility: Research Site
state: California
city: Redlands
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Santa Monica
country: United States
facility: Research Site
state: California
city: Sherman Oaks
country: United States
facility: Research Site
state: California
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Fort Collins
country: United States
facility: Research Site
state: Colorado
city: Stamford
country: United States
facility: Research Site
state: Connecticut
city: Waterbury
country: United States
facility: Research Site
state: Connecticut
city: Bradenton
country: United States
facility: Research Site
state: Florida
city: DeLand
country: United States
facility: Research Site
state: Florida
city: Fort Myers
country: United States
facility: Research site
state: Florida
city: Hallandale Beach
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Maitland
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Naples
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Sunrise
country: United States
facility: Research Site
state: Florida
city: Winter Haven
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Stockbridge
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Lisle
country: United States
facility: Research Site
state: Illinois
city: Prairie Village
country: United States
facility: Research Site
state: Kansas
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Owensboro
country: United States
facility: Research Site
state: Kentucky
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: North Attleboro
country: United States
facility: Research Site
state: Massachusetts
city: Springfield
country: United States
facility: Research Site
state: Massachusetts
city: Watertown
country: United States
facility: Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Farmington Hills
country: United States
facility: Research Site
state: Michigan
city: Jackson
country: United States
facility: Research Site
state: Michigan
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Flowood
country: United States
facility: Research Site
state: Mississippi
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Springfield
country: United States
facility: Research Site
state: Missouri
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Reno
country: United States
facility: Research Site
state: Nevada
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Hartsdale
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Staten Island
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: High Point
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Edmond
country: United States
facility: Research Site
state: Oklahoma
city: Norman
country: United States
facility: Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Allentown
country: United States
facility: Research Site
state: Pennsylvania
city: Smithfield
country: United States
facility: Research Site
state: Pennsylvania
city: Anderson
country: United States
facility: Research Site
state: South Carolina
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Kingsport
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: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
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: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
Study officials:
affiliation: Alder Biopharmaceuticals, Inc.
name: Tim Whitaker, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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: 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.
citation: 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.