Clinical trial NCT01772524: Safety, Efficacy and Pharmacokinetics of ALD403
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Keywords: Migraine Disorders
Phase 1
ALD403
Lead sponsor: Alder Biopharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-21
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria

* 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

Exclusion Criteria

* 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

Primary outcomes:
measure: Safety of ALD403: laboratory variables, ECG and adverse events
timeFrame: 24 weeks
Secondary outcomes:
measure: Evaluation of Pharmacokinetics of ALD403
timeFrame: 24 weeks
measure: Efficacy of ALD403
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Premiere Research
state: Arizona
city: Anaheim
country: United States
facility: ACT Trials
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Francisco
country: United States
facility: San Francisco Clinical Research
state: California
city: Santa Monica
country: United States
facility: CA Medical Clinic for Headache
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Miami
country: United States
facility: Miami Research
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Roslindale
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Watertown
country: United States
facility: MedVadis Research
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Headache & Neurological Institute
state: Michigan
city: Springfield
country: United States
facility: Clinvest
state: Missouri
city: Brooklyn
country: United States
facility: SPRI
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Raleigh
country: United States
facility: Wake Research
state: North Carolina
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Arlington
country: United States
facility: Neurology Associates of Arlington
state: Texas
city: Austin
country: United States
facility: Premiere Research
state: Texas
city: Salt Lake City
country: United States
facility: CRI Lifetree
state: Utah
city: Virginia Beach
country: United States
facility: Tidewater Integrated Medical Research
state: Virginia
city: Seattle
country: United States
facility: Seattle Women's: Health, Research, Gynecology
state: Washington
Study officials:
affiliation: Alder Biopharmaceuticals
name: Jeff Smith, MD
role: STUDY_DIRECTOR
References:
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: 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.