A Multicenter Assessment of ALD403 in Frequent Episodic Migraine
NCT ID: NCT02559895
Last Updated: 2020-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
898 participants
INTERVENTIONAL
2015-09-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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ALD403 Dose Level 1
ALD403 Dose Level 1 (IV)
ALD403
ALD403 Dose Level 2
ALD403 Dose Level 2 (IV)
ALD403
ALD403 Dose Level 3
ALD403 Dose Level 3 (IV)
ALD403
Placebo
Placebo (IV)
Placebo
Interventions
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ALD403
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Alder Biopharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tim Whitaker, MD
Role: STUDY_DIRECTOR
Alder Biopharmaceuticals, Inc.
Locations
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Research Site
Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Fresno, California, United States
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Fullerton, California, United States
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Long Beach, California, United States
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Montclair, California, United States
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Oceanside, California, United States
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Redlands, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Santa Monica, California, United States
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Sherman Oaks, California, United States
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Colorado Springs, Colorado, United States
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Fort Collins, Colorado, United States
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Stamford, Connecticut, United States
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Waterbury, Connecticut, United States
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Bradenton, Florida, United States
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DeLand, Florida, United States
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Fort Myers, Florida, United States
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Hallandale, Florida, United States
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Hialeah, Florida, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Orlando, Florida, United States
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Sunrise, Florida, United States
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Winter Haven, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Stockbridge, Georgia, United States
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Chicago, Illinois, United States
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Lisle, Illinois, United States
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Prairie Village, Kansas, United States
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Lexington, Kentucky, United States
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Owensboro, Kentucky, United States
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New Orleans, Louisiana, United States
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Boston, Massachusetts, United States
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North Attleboro, Massachusetts, United States
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Springfield, Massachusetts, United States
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Watertown, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Farmington Hills, Michigan, United States
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Jackson, Michigan, United States
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Minneapolis, Minnesota, United States
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Flowood, Mississippi, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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Brooklyn, New York, United States
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Hartsdale, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
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Durham, North Carolina, United States
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Greensboro, North Carolina, United States
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High Point, North Carolina, United States
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Wilmington, North Carolina, United States
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Dayton, Ohio, United States
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Edmond, Oklahoma, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Allentown, Pennsylvania, United States
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Smithfield, Pennsylvania, United States
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Anderson, South Carolina, United States
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Chattanooga, Tennessee, United States
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Chattanooga, Tennessee, United States
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Kingsport, Tennessee, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Richmond, Virginia, United States
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Virginia Beach, Virginia, United States
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Bellevue, Washington, United States
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
Research Site
Tbilisi, , Georgia
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ALD403-CLIN-006
Identifier Type: -
Identifier Source: org_study_id
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