Evaluation of long term safety of LY2951742 in Patients with Migraine

Phase 1

• Conditions: Episodic or chronic migraine headache; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-001884-38-HU
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-14
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

Patients are 18 to 65 years of age (inclusive) at the time of screening.

migraine onset prior to age 50

- Have a diagnosis of 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 beta, Cephalalgia 2013), with a history of migraine headaches of at least 1 year prior to Visit 1.

- Prior to Visit 1, a history of 4 or more migraine headache days per month on average for the past 3 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 248
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

Are currently enrolled in any other clinical trial involving any investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

Have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product. If the investigational product’s half-life is not known, 6 months should have passed prior to Visit 1.

Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to LY2951742.

Currently receiving medication or other treatments for the prevention of migraine headaches. Patients must have discontinued such treatment at least 30 days prior to Visit 2

History of persistent daily headache, cluster headache or migraine
subtypes including hemiplegic (sporadic or familial) migraine,
ophthalmoplegic migraine, and migraine with brainstem aura (basilartype
migraine) defined by IHS ICHD-3 beta.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety and tolerability of LY2951742 in patients suffering from migraine, with or without aura, for up to 1 year of treatment.;Secondary Objective: To characterize the long-term pharmacokinetics and pharmacodynamics of LY2951742.<br>To characterize the long-term immunogenicity of LY2951742.<br>To evaluate the long-term effectiveness of LY2951742 in the prevention of migraine.<br>To evaluate the long-term effect of LY2951742 on health outcomes and quality of life.<br>To evaluate patient satisfaction with medication<br>;Primary end point(s): Analysis of:<br>- treatment-emergent adverse events (TEAEs)<br>- discontinuation rates<br>- vital signs and weight<br>- electrocardiograms (ECGs)<br>- laboratory measures<br>- other safety parameters, including suicidality using the Columbia Suicide Severity Rating Scale (C-SSRS);Timepoint(s) of evaluation of this end point: baseline to 12 months in an open-label treatment phase,