Evaluation of long term safety of LY2951742 in Patients with Migraine

• Register: EUCTR
• Last refreshed on: 15 October 2018
• Main ID: EUCTR2015-001884-38-HU
• Date of registration: 14/10/2015
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: Evaluation of long term safety of LY2951742 in Patients with Migraine
• Scientific title: A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 in Patients with Migraine.
• Date of first enrolment: 07/12/2015
• Target sample size: 312
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001884-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Canada, France, Hungary, United States

Contacts

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Episodic or chronic migraine headache

Intervention(s)

Product Name: galcanezumab
Product Code: LY2951742
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: galcanezumab
Other descriptive name: LY2951742
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-

Product Name: galcanezumab
Product Code: LY2951742
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: galcanezumab
Other descriptive name: LY2951742
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-

Primary Outcome(s)

Secondary Objective: To characterize the long-term pharmacokinetics and pharmacodynamics of LY2951742.
To characterize the long-term immunogenicity of LY2951742.
To evaluate the long-term effectiveness of LY2951742 in the prevention of migraine.
To evaluate the long-term effect of LY2951742 on health outcomes and quality of life.
To evaluate patient satisfaction with medication

Primary end point(s): Analysis of:
- treatment-emergent adverse events (TEAEs)
- discontinuation rates
- vital signs and weight
- electrocardiograms (ECGs)
- laboratory measures
- 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,

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 Outcome(s)

Secondary end point(s): -Assessment of serum concentrations of LY2951742 to enable a pharmacokinetic evaluation.
-Assessment of plasma concentrations of CGRP to enable a pharmacodynamic evaluation of target engagement of LY2951742.
-Assessment of the development and consequences of anti-drug antibodies (ADA) to LY2951742.
-Collection of samples for subsequent evaluation of neutralizing ADAs upon availability of the validated assay.
-Mean change from baseline in the number of migraine headache days;
-Mean change from baseline in the number of headache days;
-Proportion of patients meeting 50% response criteria (reduction of at least 50% in the number of migraine headache days);
-Mean changes in patient’s global impression of illness as measured by PGI-Severity at baseline and PGI-Improvement post-baseline
-Mean change from baseline to endpoint in the evaluation of the Migraine Disability Assessment test (MIDAS) total score and individual items;
-Mean change from baseline to endpoint in the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) total score and individual domains;
-Analysis of safety parameters
-Satisfaction with medication will be assessed using the Patient Satisfaction with Medication Questionnaire-Modified (PSMQ-M).
-Satisfaction with and ease of use of the device for injection will be assessed using the Subcutaneous Administration Assessment Questionnaire (SQAAQ)

Timepoint(s) of evaluation of this end point: Assessment of the development and consequences of anti-drug antibodies to LY2951742.
Collection of samples for subsequent evaluation of neutralizing anti-drug antibodies.

Secondary ID(s)

I5Q-MC-CGAJ

Source(s) of Monetary Support

Eli Lilly and Company