Clinical trial NCT01625988: A Study of LY2951742 in Participants With Migraine
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine Headache
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-06-22
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of LY2951742 in the prevention of migraine headache in migraineurs with or without aura during 3 months of treatment.

Detailed description: The study is comprised of 4 trial periods:

1. Screening and washout (5-45 days)
2. Baseline for assessment of the type, frequency, and severity of headaches (28-38 days)
3. Treatment (12 weeks)
4. Follow-up (12 weeks)

Eligibility criteria: Inclusion Criteria:

* Have a history of migraine as defined by the International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004) of at least 1 year prior to enrollment, migraine onset prior to age 50, and a moderate frequency of migraine headaches
* Women of child-bearing potential (not surgically sterile or at least 1 year post-menopause) must test negative for pregnancy at the time of screening based on a serum pregnancy test and must agree to use a reliable method of birth control during the study and for 3 months following completion of participation in the study
* Have clinical laboratory test results within normal reference ranges or, if outside the normal range, judged not clinically significant by the Investigator
* Must not be on any migraine prevention therapy, including botulinum toxin (Botox)
* Agree not to post any personal medical data related to the study or information related to the study on any website or social media site (for example, Facebook, Twitter, et cetera) until the trial has completed

Exclusion Criteria:

* Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device, or concurrent enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study
* Previous completion or withdrawal from this study or any other study investigating LY2951742 or other therapeutic antibodies that target calcitonin gene-related peptide (CGRP)
* History of chronic migraine or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and basilar-type migraine
* History of headache (for example, cluster headache or Medication Overuse Headache \[MOH\]) other than migraine or tension type headache as defined by IHS ICHD-II within 12 months prior to randomization
* Evidence of significant active psychiatric disease including, but not limited to, manic depressive illness, schizophrenia, generalized anxiety disorder, obsessive compulsive disorder, personality disorders, or other serious mood, anxiety, depression, or substance use disorders
* Have a history or presence of any other medical illness that in the judgment of the Investigator, indicates a medical problem that would preclude study participation
* Women who are pregnant or nursing
* Confirmed corrected QT (QTc) interval \>470 milliseconds (msec) for women and \>450 for men
* Excessive alcohol, opiate, or barbiturate use; history of drug abuse or dependence
* In the opinion of the Investigator, have no other issues that would interfere with compliance with the study requirements and completion of evaluations required for this study

Primary outcomes:
measure: Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-day Period of the 12-week Treatment Phase
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Mean Change From Baseline in the Number of Headache Days in the Last 28-day Period of the 12-week Treatment Phase
timeFrame: Baseline, 12 weeks
measure: Mean Change From Baseline in the Number of Migraine Attacks in the Last 28-day Period of the 12-week Treatment Phase
timeFrame: Baseline, 12 weeks
measure: Percentage of Responders
timeFrame: Baseline, 4, 8, and 12 weeks
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Neurological Physicians of Arizona / Clinical Research Advantage
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Foundation for Medical Education and Research - Mayo Clinic
state: Arizona
city: Encino
country: United States
facility: PRI Encino
state: California
city: Huntington Beach
country: United States
facility: Allergy and Asthma Specialists Medical Group
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network Inc.
state: California
city: Los Alamitos
country: United States
facility: PRI Los Alamitos
state: California
city: Newport Beach
country: United States
facility: PRI Newport Beach
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco (UCSF) Medical Center - Headache Center
state: California
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache Inc
state: California
city: Denver
country: United States
facility: Radiant Research - Denver
state: Colorado
city: Maitland
country: United States
facility: Florida Clinical Research Center LLC
state: Florida
city: Melbourne
country: United States
facility: Accelovance, Inc
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Pembroke Pines
country: United States
facility: Broward Research Group
state: Florida
city: Sunrise
country: United States
facility: Neurology Clinical Research Inc
state: Florida
city: Watertown
country: United States
facility: MedVadis Research
state: Massachusetts
city: Kalamazoo
country: United States
facility: Westside Family Medical Center, PC
state: Michigan
city: Chesterfield
country: United States
facility: Ryan Headache Center, St. John's Mercy Medical Group
state: Missouri
city: Springfield
country: United States
facility: Clinvest, A Division of Banyan Group, Inc.
state: Missouri
city: Fremont
country: United States
facility: Prarie Fields Medicine/Clinical Research Advantage
state: Nebraska
city: Henderson
country: United States
facility: James Meli DO Ltd (Clinical Research Advantage)
state: Nevada
city: Henderson
country: United States
facility: Clinical Research Advantage
state: Nevada
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Oklahoma City
country: United States
facility: COR Clinical Research, LLC
state: Oklahoma
city: Bristol
country: United States
facility: PMG Research of Bristol
state: Tennessee
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Nashville
country: United States
facility: Nashville Neuroscience Group
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology and Sleep Lab
state: Texas
city: Austin
country: United States
facility: Neurology Studies of Austin, A Division of DermResearch Inc.
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network (CTN Texas)
state: Texas
city: McLean
country: United States
facility: Neurology & Headache Treatment Center
state: Virginia
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Stauffer VL, Turner I, Kemmer P, Kielbasa W, Day K, Port M, Quinlan T, Camporeale A. Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials. J Headache Pain. 2020 Jun 23;21(1):79. doi: 10.1186/s10194-020-01148-9.
citation: Goadsby PJ, Dodick DW, Martinez JM, Ferguson MB, Oakes TM, Zhang Q, Skljarevski V, Aurora SK. Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis. J Neurol Neurosurg Psychiatry. 2019 Aug;90(8):939-944. doi: 10.1136/jnnp-2018-320242. Epub 2019 Apr 19.
citation: Dodick DW, Goadsby PJ, Spierings EL, Scherer JC, Sweeney SP, Grayzel DS. Safety and efficacy of LY2951742, a monoclonal antibody to calcitonin gene-related peptide, for the prevention of migraine: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2014 Sep;13(9):885-92. doi: 10.1016/S1474-4422(14)70128-0. Epub 2014 Aug 10.