GLADIATOR
Research type
Research Study
Full title
An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR)
IRAS ID
207680
Contact name
Peter Goadsby
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2015-005674-37
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
103,420, IND
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This is an extension study of the COL MIG-301 and COL MIG-302 studies. The study is open-label, so both the participant and the study doctor will know the participant is taking the experimental study drug, lasmiditan. \n\nThe main purpose of the study is to find out if lasmiditan, is safe in long-term irregular use in doses of 100 mg and 200 mg and if it is effective in making migraine headache pain better along with the most bothersome symptom selected by the participant from the associated symptoms of nausea, sensitivity to light and sensitivity to sound. \n\nThe doses of lasmiditan to be given in this study have been tested and shown to be safe and well tolerated in healthy subjects and in patients with migraine. \n\nParticipants will be divided into two groups at random, each group will receive a different dose (100 mg or 200 mg) of the study drug. The results will be compared to see if one is better than the other. This study is set up so that participants have an equal chance of receiving 100 mg or 200 mg of lasmiditan for the first dose and the second dose, if needed for rescue (migraine does not go away after 2 hours) or recurrence (migraine goes away after 2 hours, but comes back). \n\nThe study will take up to 12 months and will consist of a screening visit, a treatment period with clinic visits at months 1, 3, 6, and 9 and an End-of-Study visit at month 12 (Visit 6). Participants may be withdrawn from the study if they do not have to use the study drug for any migraines for more than one month.\n\nApproximately 2580 subjects will participate in this study at up to 220 sites in the U.S., Canada and Europe.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
16/LO/1482
Date of REC Opinion
1 Nov 2016
REC opinion
Further Information Favourable Opinion