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NCT02565186

An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine

Last Updated: 2020-08-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-07

Study Completion Date

2019-08-20

Brief Summary

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This is a prospective, randomized, open-label study in subjects with migraine who have completed the Phase 3 studies, COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174) or for a subset of lasmiditan-naïve subjects with migraine. The study is designed to evaluate the safety and tolerability of long-term intermittent use of lasmiditan 100 mg and of lasmiditan 200 mg, as the first dose and as a second dose, for the acute treatment of migraine. Long term efficacy will also be evaluated.

Detailed Description

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Conditions

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Migraine Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lasmiditan 100mg

Participants received oral dose of 100 milligrams (mg) Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.

Group Type EXPERIMENTAL

Lasmiditan

Intervention Type DRUG

oral tablet

Lasmiditan 200mg

Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.

Group Type EXPERIMENTAL

Lasmiditan

Intervention Type DRUG

oral tablet

Interventions

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Lasmiditan

oral tablet

Intervention Type DRUG

Other Intervention Names

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LY573144

Eligibility Criteria

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Inclusion Criteria

* Able and willing to give written informed consent and authorize Health Insurance Portability and Accountability Act (HIPAA).
* Completed COL MIG-301 or COL MIG-302 within the last 12 weeks. Subjects that completed COL MIG-301 prior to COL MIG-305 being available will be allowed to enroll as long as enrollment occurs within 4 weeks of COL MIG-305 activation at their site. (NOTE: Additional subjects may qualify if they completed COL MIG-301 or COL MIG-302 \>12 weeks prior or if they have not participated in either prior study, but meet eligibility criteria outlined for COL MIG-302.)
* Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).
* Able and willing to complete an electronic diary to record details of all migraine attacks treated with study drug.

Exclusion Criteria

* Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.
* Pregnant or breast-feeding women.
* Women of child-bearing potential not using or not willing to use highly effective contraception.
* Participant is at imminent risk of suicide (positive response to question 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
* Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes since completing COL MIG-301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).
* Participation in any clinical trial of an experimental drug or device since completing EoS/Visit 2 of COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Southview Medical Group

Birmingham, Alabama, United States

Site Status

Simon Williamson Clinic

Birmingham, Alabama, United States

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Achieve Clinical Research, LLC

Birmingham, Alabama, United States

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Alabama Clinical Therapeutics

Birmingham, Alabama, United States

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Medical Affiliated Research Center

Huntsville, Alabama, United States

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East Valley Family Physicians, PLC

Chandler, Arizona, United States

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Radiant Research

Chandler, Arizona, United States

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Warner Family Practice

Chandler, Arizona, United States

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Fountain Hills Family Practice, P.C.

Fountain Hills, Arizona, United States

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Neurological Physicians of Arizona Inc

Gilbert, Arizona, United States

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Thunderbird Internal Medicine

Glendale, Arizona, United States

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Thomas C. Lenzmeier, M.D., P.C

Glendale, Arizona, United States

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Central Arizona Medical Associates, PC

Mesa, Arizona, United States

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