Study Results
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Basic Information
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COMPLETED
PHASE1
163 participants
INTERVENTIONAL
2013-01-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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ALD403
Single IV Dose on Day 0
ALD403
Saline
Single IV infusion on Day 0
Placebo
Interventions
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ALD403
Placebo
Eligibility Criteria
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Inclusion Criteria
* History of migraine ≥ 12 months with
* ≥ 5 and ≤ 14 migraine days in each 28 day period in the 3 months prior to screening
* use of acute migraine medications ≤ 14 days per 28 day period and, within those days, ≤ 10 days of triptan use per 28 day period in the 3 months prior to screening and the 28 day period of completion of eDiary prior to randomization
* Women of child-bearing potential and males with partners of child-bearing potential must agree to use adequate contraception (oral or injectable \[depot\] estrogen, and/or progestogen, or selective estrogen receptor modulator contraceptive therapeutic, intrauterine contraceptive device, or double barrier method \[e.g., condom and diaphragm or spermicidal gel\]). Non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before screening
* Any hormonal therapy (e.g., oral contraceptives, hormone replacement therapy) use is stable and ongoing for at least 3 months prior to screening and during the 28 day period from screening to randomization
* Agree not to post any personal medical data related to the trial or information related to the trial on any website or social media site (e.g., Facebook, Twitter) until the trial has been completed
Exclusion Criteria
* Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache, basilar, hemiplegic, or familial hemiplegic migraine
* Regular use (greater than 7 days) of prophylactic headache medication (any preventive medication or supplement with evidence of efficacy from at least 1 placebo-controlled trial) within 3 months, or onabotulinumtoxin A within 6 months prior to screening or during the 28 day period prior to randomization
* Cardiac surgery or cardiac symptoms within 3 months of screening and during the 28 day period prior to randomization
* Suspected or diagnosis of hypertension with or without antihypertensive treatment
* Any ongoing co-morbidity that in the opinion of the Investigator will interfere with the participation in the trial
* Body Mass Index (BMI) \> 39 at screening
* Pregnant, breast-feeding, or planning to become pregnant during the trial
* Patients who have used opioids \> 5 days for the treatment of pain in more than 2 of the 6 months prior to screening or in the 28 day period prior to randomization
18 Years
55 Years
ALL
No
Sponsors
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Alder Biopharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeff Smith, MD
Role: STUDY_DIRECTOR
Alder Biopharmaceuticals
Locations
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Premiere Research
Phoenix, Arizona, United States
ACT Trials
Anaheim, California, United States
Collaborative Neuroscience Network, Inc.
Long Beach, California, United States
Medical Center for Clinical Research
San Diego, California, United States
San Francisco Clinical Research
San Francisco, California, United States
CA Medical Clinic for Headache
Santa Monica, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
MD Clinical
Hallandale, Florida, United States
Miami Research
Miami, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Boston Clinical Trials
Roslindale, Massachusetts, United States
MedVadis Research
Watertown, Massachusetts, United States
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, United States
Clinvest
Springfield, Missouri, United States
SPRI
Brooklyn, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Wake Research
Raleigh, North Carolina, United States
Community Research
Cincinnati, Ohio, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
ClinSearch
Chattanooga, Tennessee, United States
Neurology Associates of Arlington
Arlington, Texas, United States
Premiere Research
Austin, Texas, United States
CRI Lifetree
Salt Lake City, Utah, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, United States
Countries
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References
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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.
Dodick DW, Goadsby PJ, Silberstein SD, Lipton RB, Olesen J, Ashina M, Wilks K, Kudrow D, Kroll R, Kohrman B, Bargar R, Hirman J, Smith J; ALD403 study investigators. Safety and efficacy of ALD403, an antibody to calcitonin gene-related peptide, for the prevention of frequent episodic migraine: a randomised, double-blind, placebo-controlled, exploratory phase 2 trial. Lancet Neurol. 2014 Nov;13(11):1100-1107. doi: 10.1016/S1474-4422(14)70209-1. Epub 2014 Oct 5.
Other Identifiers
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ALD403-CLIN-002
Identifier Type: -
Identifier Source: org_study_id
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