Overview

This trial is active, not recruiting.

Condition migraine
Treatment ly2951742
Phase phase 3
Sponsor Eli Lilly and Company
Start date November 2015
End date September 2017
Trial size 250 participants
Trial identifier NCT02614287, 15770, 2015-001884-38, I5Q-MC-CGAJ

Summary

The main purpose of this study is to evaluate the longer term safety of the study drug known as LY2951742 in participants with episodic or chronic migraine.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Dose Level 1 LY2951742 given by subcutaneous (SC) injection once a month for up to 12 months.
ly2951742
Administered SC
(Experimental)
Dose Level 2 LY2951742 given by SC injection once a month for up to 12 months.
ly2951742
Administered SC

Primary Outcomes

Measure
Percentage of Participants who Discontinue
time frame: Baseline through Month 12

Secondary Outcomes

Measure
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2951742
time frame: Baseline through Month 12
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
time frame: Baseline through Month 12
Percentage of Participants Developing Anti-Drug Antibodies to LY2951742
time frame: Baseline through Month 12
Mean Change from Baseline in the Number of Migraine Headache Days
time frame: Baseline, Month 12
Mean Change from Baseline in the Number of Headache Days
time frame: Baseline, Month 12
Proportion of Participants with Reduction from Baseline ≥50% in Monthly Migraine Headache Days
time frame: Month 12
Mean Change from Baseline in the Frequency of Medication Use for the Acute Treatment of Migraines or Headaches
time frame: Baseline, Month 12
Mean Patient Global Impression-Improvement (PGI-I) Score
time frame: Month 12
Mean Change from Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
time frame: Baseline, Month 12
Mean Change from Baseline on the Migraine-Specific Quality of Life Questionnaire
time frame: Baseline, Month 12
Participant Satisfaction with Medication Questionnaire-Modified (PSMQ-M) Score
time frame: Month 12
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
time frame: Month 12

Eligibility Criteria

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

Inclusion Criteria: - Have a diagnosis of episodic or chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1, 1.2 or 1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50. - Prior to baseline, a history of 4 or more migraine headache days per month on average for the past 3 months. 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, Long-Term, Open-Label Safety Study of LY2951742 in Patients With Migraine
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.