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A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine

Acute Migraine Clinical Trial

Official title:
A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine

Clinical Trial Summary

This is a randomised, placebo controlled, double blind, crossover proof of concept study to investigate the efficacy and safety of oral LAT8881 in acute migraine, with or without aura.

Clinical Trial Description

Subjects enrolled in the study will be randomised to receive investigational medicinal product (LAT8881 60 mg or placebo), to be taken at the onset (within one hour from the onset of pain) of a migraine headache of moderate to severe intensity [Numeric rating scale greater than 4]. Rescue medication should not be taken until at least 2 hours post dose. Subjects will be given a single dose of either active or placebo, to treat one migraine headache. After treatment of one migraine headache (or a maximum 28 days) the subject will return to the clinic for re-evaluation and crossover to the second treatment. After treatment of one migraine headache in the second treatment period or a maximum of 28 days from commencement of the second treatment period, the subject will return to the clinic for re-evaluation. An End of study visit (telephone) will occur 7 days after the end of the second treatment period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04153409
Study type Interventional
Source Lateral Pharma Pty Ltd
Contact
Status Completed
Phase Phase 2
Start date September 24, 2019
Completion date April 10, 2020
View Details
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