Overview

This trial is active, not recruiting.

Condition migraine
Treatments ly2951742, placebo
Phase phase 3
Sponsor Eli Lilly and Company
Start date November 2015
End date February 2017
Trial size 825 participants
Trial identifier NCT02614183, 15767, I5Q-MC-CGAG

Summary

The main purpose of this study is to evaluate the efficacy of the study drug known as LY2951742 in participants with episodic migraine.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Dose level 1 LY2951742 given by subcutaneous (SC) injection once a month for 6 months.
ly2951742
Administered SC
(Experimental)
Dose level 2 LY2951742 given by SC injection once a month for 6 months.
ly2951742
Administered SC
(Placebo Comparator)
Placebo given by SC injection once a month for 6 months.
placebo
Administered SC

Primary Outcomes

Measure
Mean Change from Baseline in the Number of Monthly Migraine Headache Days
time frame: Baseline, Month 6

Secondary Outcomes

Measure
Proportion of Participants with Reduction from Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
time frame: Month 6
Mean Change from Baseline on the Migraine-Specific Quality of Life Questionnaire
time frame: Baseline, Month 6
Mean Change from Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache
time frame: Baseline, Month 6
Mean Change from Baseline in the Patient Global Impression of Severity (PGI-S) Score
time frame: Baseline, Month 6
Mean Change from Baseline in Headache Hours
time frame: Baseline, Month 6
Mean Change from Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
time frame: Baseline, Month 6
Percentage of Participants Developing Anti-drug Antibodies to LY2951742
time frame: Baseline through Month 6
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2951742
time frame: Baseline through Month 6
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
time frame: Baseline through Month 6

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Have a diagnosis of episodic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50. Exclusion Criteria: - Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product. - Current use or prior exposure to LY2951742 or another CGRP antibody. - Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to LY2951742. - History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.

Additional Information

Official title A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Migraine - the EVOLVE-1 Study
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.