NCT04153409

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Lateral Pharma Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acute Migraine

Interventions

Type	Name	Description
DRUG	LAT8881	Two 30 mg capsules of LAT8881
DRUG	Placebo	Two capsules of placebo

Timeline

• Start date: 2019-09-24
• Primary completion: 2020-02-15
• Completion: 2020-04-10
• First posted: 2019-11-06
• Last updated: 2021-04-28
• Results posted: 2021-03-30

Locations

3 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study