A Study of LY2951742 in Participants With Migraine

Migraine Headache Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625988
• Other study ID #: ART-01
• Secondary ID: ART-01
• Status: Completed
• Phase: Phase 2
• Start date: June 28, 2012
• Est. completion date: September 18, 2013

Study information

• Verified date: April 2014
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: September 18, 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Drug:
• LY2951742

• Placebo

Locations

Country	Name	City	State
United States	FutureSearch Trials of Neurology and Sleep Lab	Austin	Texas
United States	Neurology Studies of Austin, A Division of DermResearch Inc.	Austin	Texas
United States	PMG Research of Bristol	Bristol	Tennessee
United States	ClinSearch	Chattanooga	Tennessee
United States	Ryan Headache Center, St. John's Mercy Medical Group	Chesterfield	Missouri
United States	FutureSearch Trials of Dallas	Dallas	Texas
United States	Radiant Research - Denver	Denver	Colorado
United States	PRI Encino	Encino	California
United States	Prarie Fields Medicine/Clinical Research Advantage	Fremont	Nebraska
United States	Neurological Physicians of Arizona / Clinical Research Advantage	Gilbert	Arizona
United States	PharmQuest	Greensboro	North Carolina
United States	Clinical Research Advantage	Henderson	Nevada
United States	James Meli DO Ltd (Clinical Research Advantage)	Henderson	Nevada
United States	Clinical Trial Network (CTN Texas)	Houston	Texas
United States	Allergy and Asthma Specialists Medical Group	Huntington Beach	California
United States	Westside Family Medical Center, PC	Kalamazoo	Michigan
United States	Collaborative Neuroscience Network Inc.	Long Beach	California
United States	PRI Los Alamitos	Los Alamitos	California
United States	Florida Clinical Research Center LLC	Maitland	Florida
United States	Neurology & Headache Treatment Center	McLean	Virginia
United States	Accelovance, Inc	Melbourne	Florida
United States	Nashville Neuroscience Group	Nashville	Tennessee
United States	PRI Newport Beach	Newport Beach	California
United States	Renstar Medical Research	Ocala	Florida
United States	COR Clinical Research, LLC	Oklahoma City	Oklahoma
United States	Broward Research Group	Pembroke Pines	Florida
United States	Arizona Research Center	Phoenix	Arizona
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Medical Center for Clinical Research	San Diego	California
United States	San Francisco Clinical Research Center	San Francisco	California
United States	University of California, San Francisco (UCSF) Medical Center - Headache Center	San Francisco	California
United States	California Medical Clinic for Headache Inc	Santa Monica	California
United States	Mayo Foundation for Medical Education and Research - Mayo Clinic	Scottsdale	Arizona
United States	Clinvest, A Division of Banyan Group, Inc.	Springfield	Missouri
United States	Neurology Clinical Research Inc	Sunrise	Florida
United States	MedVadis Research	Watertown	Massachusetts
United States	PMG Research of Winston-Salem	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-day Period of the 12-week Treatment Phase	The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of =30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least square (LS) means were calculated using mixed model repeated measures (MMRM) with baseline value, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.	Baseline, 12 weeks
Secondary	Mean Change From Baseline in the Number of Headache Days in the Last 28-day Period of the 12-week Treatment Phase	Number of calendar days on which a headache lasts =4 hours which includes migraines, probable migraines (PM) and nonmigraines. Criteria for migraine headache (MH) was adapted from standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). Definition of MH was headache with or without aura, of =30 min duration, and with both ("A" and "B") required features from IHS ICHD-II definition. Required feature "A" includes =2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea and/or vomiting, or photophobia and phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.	Baseline, 12 weeks
Secondary	Mean Change From Baseline in the Number of Migraine Attacks in the Last 28-day Period of the 12-week Treatment Phase	A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria for a migraine headache was adapted from the standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of =30 minutes duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.	Baseline, 12 weeks
Secondary	Percentage of Responders	Percentage of participants with greater than 50% reduction in the number of migraine headache days in a 28-day period. The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of =30 minutes duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia.	Baseline, 4, 8, and 12 weeks