COL MIG-302 Lasmiditan Compared to Placebo to Treat Migraine
Research type
Research Study
Full title
A Study of Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute TReaTment of MigrAiNe: A randomized, double-blind, placebo-controlled parallel group study (SPARTAN)
IRAS ID
207236
Contact name
Peter Goadsby
Contact email
Sponsor organisation
CoLucid Pharmaceuticals, Inc.
Eudract number
2015-005689-40
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
103,420, IND
Duration of Study in the UK
0 years, 11 months, 9 days
Research summary
The study purpose is to find out if the study drug, lasmiditan, is safe and effective in relieving migraine headache pain along with the most bothersome symptom selected from nausea, sensitivity to light and sensitivity to sound, compared to placebo. Placebo is a ‘dummy treatment’ which looks like the study drug but contains no active ingredient. \n\nTriptans are the therapy of choice to treat migraine, however they cannot be taken by patients with heart disease due to their narrowing effect on veins. Consequently there is a need for new migraine treatments. In phase 2 clinical trials, lasmiditan was effective at treating migraine and there were no untoward events that suggested narrowing effects on veins. Thus lasmiditan is a candidate for development as a new migraine treatment.\n\nThis study is testing lasmiditan in patients who have a history of migraine with or without aura. Around 2968 subjects will take part at up to 150 study centres worldwide.\n\nParticipants will be split into 4 groups, each group will be given a different treatment, this will be done by chance. Each participant will be given a dosing card which will contain 4 tablets, and instructed to take 2 tablets for the first dose and 2 tablets for the second dose, if needed for rescue (migraine does not go away after 2 hours) or recurrence (migraine goes away after 2 hours, but then comes back). The treatment will be either 50 mg, 100 mg, 200 mg lasmiditan or placebo. Neither the participant or the study doctor will know what they are receiving.\n\nThe study will take approximately 11 weeks, consisting of:\n- a screening visit with a telephone call within 7 days to confirm eligibility;\n- a treatment period of up to 8 weeks;\n- an end-of-study visit within one week of treating a migraine.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
16/LO/1447
Date of REC Opinion
18 Oct 2016
REC opinion
Favourable Opinion