Safety, Efficacy and Pharmacokinetics of ALD403
A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 1b Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of a Single Dose of ALD403 Administered Intravenously in Patients With Frequent Episodic Migraines
1 other identifier
interventional
163
1 country
26
Brief Summary
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of a single dose of ALD403 in the prevention of migraine headache in frequent episodic migraineurs for 24 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2013
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 17, 2013
CompletedFirst Posted
Study publicly available on registry
January 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedJanuary 8, 2016
January 1, 2016
11 months
January 17, 2013
January 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of ALD403: laboratory variables, ECG and adverse events
* Physical Examination * Vital signs * 12-lead ECG (electrocardiogram) * Clinical laboratory tests (hematology, chemistry) * Number of participants with Adverse Events
24 weeks
Secondary Outcomes (2)
Evaluation of Pharmacokinetics of ALD403
24 weeks
Efficacy of ALD403
12 weeks
Study Arms (2)
ALD403
EXPERIMENTALSingle IV Dose on Day 0
Saline
PLACEBO COMPARATORSingle IV infusion on Day 0
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1)
- 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
You may not qualify if:
- Confounding pain syndromes including fibromyalgia, chronic musculoskeletal (e.g., low back pain), psychiatric conditions, dementia, or major neurological disorders other than migraine that interfere with the participation in the trial
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Premiere Research
Phoenix, Arizona, 85027, United States
ACT Trials
Anaheim, California, 92801, United States
Collaborative Neuroscience Network, Inc.
Long Beach, California, 90806, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
San Francisco Clinical Research
San Francisco, California, 94109, United States
CA Medical Clinic for Headache
Santa Monica, California, 90404, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
MD Clinical
Hallandale, Florida, 33009, United States
Miami Research
Miami, Florida, 33143, United States
Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Boston Clinical Trials
Roslindale, Massachusetts, 02131, United States
MedVadis Research
Watertown, Massachusetts, 02472, United States
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Clinvest
Springfield, Missouri, 65807, United States
SPRI
Brooklyn, New York, 11235, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Wake Research
Raleigh, North Carolina, 27612, United States
Community Research
Cincinnati, Ohio, 45255, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
ClinSearch
Chattanooga, Tennessee, 37421, United States
Neurology Associates of Arlington
Arlington, Texas, 76017, United States
Premiere Research
Austin, Texas, 78705, United States
CRI Lifetree
Salt Lake City, Utah, 84106, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454, United States
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, 98105, United States
Related Publications (3)
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.
PMID: 34823467DERIVEDSmith 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.
PMID: 33781209DERIVEDDodick 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.
PMID: 25297013DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jeff Smith, MD
Alder Biopharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2013
First Posted
January 21, 2013
Study Start
January 1, 2013
Primary Completion
December 1, 2013
Study Completion
February 1, 2014
Last Updated
January 8, 2016
Record last verified: 2016-01