A Study of LY2951742 in Participants With Migraine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01625988
First received: June 20, 2012
Last updated: April 14, 2014
Last verified: April 2014
  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:


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:

  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)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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

No publications provided

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

ClinicalTrials.gov processed this record on August 19, 2014