Ignite Creation Date:
2024-05-06 @ 1:54 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04153409
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2019-11-04
Brief Title:
A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine
Sponsor:
Lateral Pharma Pty Ltd
Organization:
Lateral Pharma Pty Ltd
Study Overview
Official Title:
A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None