A Study of LY2951742 in Participants With Migraine

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Migraine Headache	Drug: LY2951742; Drug: Placebo	Phase 2

Detailed Description:

The study is comprised of 4 trial periods:

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

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	190 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Migraine
Study Start Date :	June 2012
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	September 2013

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: LY2951742; LY2951742: 150 milligrams	Drug: LY2951742; Administered subcutaneously once every other week for 12 weeks
Placebo Comparator: Placebo; Placebo: 0.9% Sodium Chloride	Drug: Placebo; Administered subcutaneously once every other week for 12 weeks

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Mean change from baseline in the number of migraine headache days in a 28-day period [ Time Frame: Baseline to 12 weeks ]

Secondary Outcome Measures :

1. Mean change from baseline in the number of headache days per 28-day period [ Time Frame: Baseline to 12 weeks ]
2. Mean change from baseline in the number of migraine attacks per 28-day period [ Time Frame: Baseline to 12 weeks ]
3. Proportion of responders [ Time Frame: Baseline to 12 weeks ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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 greater than (>) 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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 37 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:	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)	Eli Lilly and Company

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01625988 History of Changes
Other Study ID Numbers:	ART-01; ART-01 ( Other Identifier: Eli Lilly and Company )
First Posted:	June 22, 2012
Last Update Posted:	May 7, 2014
Last Verified:	April 2014

Additional relevant MeSH terms:

Migraine Disorders; Headache; Headache Disorders, Primary; Headache Disorders; Brain Diseases	Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms