A Study of LY2951742 in Participants With Migraine - Full Text View

Purpose

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	Intervention	Phase
Migraine Headache	Drug: LY2951742 Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Migraine

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Mean change from baseline in the number of migraine headache days in a 28-day period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean change from baseline in the number of headache days per 28-day period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
Mean change from baseline in the number of migraine attacks per 28-day period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
Proportion of responders [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]


Enrollment:	190
Study Start Date:	June 2012
Study Completion Date:	September 2013
Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Detailed Description:

The study is comprised of 4 trial periods:

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

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625988

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

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
Study First Received:	June 20, 2012
Last Updated:	April 14, 2014
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 27, 2016