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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01625988
Other study ID # ART-01
Secondary ID ART-01
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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