An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine
NCT ID: NCT02985398
Last Updated: 2020-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
128 participants
INTERVENTIONAL
2016-12-31
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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ALD403 (Eptinezumab) Dose Level 1
ALD403 (Eptinezumab) Dose Level 1 (IV)
ALD403 (Eptinezumab)
Interventions
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ALD403 (Eptinezumab)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome).
* Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. Patients with a lifetime history of psychosis, mania, or dementia are excluded.
* History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine.
18 Years
65 Years
ALL
No
Sponsors
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Alder Biopharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Research Site
San Diego, California, United States
Research Site
Santa Monica, California, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Bradenton, Florida, United States
Research Site
DeLand, Florida, United States
Massachusetts
Miami, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Winter Haven, Florida, United States
Research Site
Prairie Village, Kansas, United States
Massachusetts
Boston, Massachusetts, United States
Research Site
North Attleboro, Massachusetts, United States
02481
Wellesley, Massachusetts, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Brooklyn, New York, United States
Research Site
Rochester, New York, United States
Research Site
Dayton, Ohio, United States
Research Site
Mt. Pleasant, South Carolina, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Fort Worth, Texas, United States
Research Site
Bellevue, Washington, United States
Countries
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References
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Blumenfeld A, Ettrup A, Hirman J, Ebert B, Cady R. Long-term reductions in disease impact in patients with chronic migraine following preventive treatment with eptinezumab. BMC Neurol. 2022 Jul 8;22(1):251. doi: 10.1186/s12883-022-02774-3.
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.
Kudrow D, Cady RK, Allan B, Pederson SM, Hirman J, Mehta LR, Schaeffler BA. Long-term safety and tolerability of eptinezumab in patients with chronic migraine: a 2-year, open-label, phase 3 trial. BMC Neurol. 2021 Mar 19;21(1):126. doi: 10.1186/s12883-021-02123-w.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ALD403-CLIN-013
Identifier Type: -
Identifier Source: org_study_id
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