Randomised Controlled Trial Of Lasmiditan Over Four Migraine Attacks.
Research type
Research Study
Full title
A phase 3 global, multicenter, placebo-controlled, double-blind study to assess the efficacy, consistency of response, and safety of lasmiditan in acute treatment of 4 migraine attacks with or without aura.
IRAS ID
250494
Contact name
Peter Goadsby
Contact email
Sponsor organisation
Eli Lilly Cork Ltd. - Global Busines Solutions Centre
Eudract number
2018-001661-17
Duration of Study in the UK
1 years, 5 months, 17 days
Research summary
Migraine is a common neurological disorder that ranks among the top 7 most debilitating diseases and as the third most common disease in the world. Use of substances called triptans has improved it's treatment, however they are not effective on or not tolerated by some patients, and there are safety concerns about their effects on patients’ heart and blood vessels. Other treatments are not as effective or have undesirable side effects. There is a need to develop new alternative treatments, especially ones that do not affect the heart and blood vessels.
Lasmiditan is a substance chemically different from triptans, it's effect in the treatment of migraine is also different from triptans. Release of certain proteins in the brain eventually lead to the pain experienced in migraine, lasmiditan works by decreasing the release of these proteins without affecting any blood vessels. It has been shown to be effective, safe and tolerable in multiple clinical studies and most unwanted effects reported were mild or moderate in severity and resolved over a short period of time.
H8H-MC-LAIJ is a study of at least 1600 adult patients suffering from migraine. It will assess the effectiveness of lasmiditan and it's consistency in obtaining effective responses, from treating 4 migraine attacks in patients, and by comparing results from these same assessments on patients using a placebo treatment. Patients included on this study will need to have at least a year's history of migraine, with 3 to 8 migraine attacks per month that disables them and affects their quality of life. Each patient will attend a screening visit, a randomization visit, a Treatment Period of up to 16 weeks that includes phone call check-ins and 1 clinic visit, and an end-of-study visit. Study assessments will include: physical and neurological examinations, completing questionnaires, blood and urine tests, and an ECG.
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/1847
Date of REC Opinion
19 Feb 2019
REC opinion
Further Information Favourable Opinion