Ignite Creation Date:
2024-10-25 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602479
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomised Multicentre Parallel-Group Treatment Double-Blind Study to Investigate the Safety and Efficacy of Subcutaneous MEDI0618 in the Reduction of Migraine Headache Days Compared to Placebo in Adult Participants With Episodic Migraine
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AURORA
Brief Summary:
The purpose of this Phase 2 study is to evaluate the safety and efficacy of SC MEDI0618 compared to placebo in participants with episodic migraine
Detailed Description:
This Phase 2 randomised multicentre parallel-group treatment double-blind placebo-controlled study is designed to evaluate the safety and efficacy of SC MEDI0618 in participants with episodic migraine
The study includes a cohort of participants who have a history of unsuccessful treatment with 3 small molecule migraine preventive treatments from different classes and are eligible to receive an aCGRP therapy aCGRP-N The study also includes a smaller cohort of participants who have failed one or more aCGRP therapies aCGRP-IRs These participants are also required to have a history of unsuccessful treatment with 3 small molecule migraine preventive treatments from different classes
The study includes a cohort of participants who have a history of unsuccessful treatment with 3 small molecule migraine preventive treatments from different classes and are eligible to receive an aCGRP therapy aCGRP-N The study also includes a smaller cohort of participants who have failed one or more aCGRP therapies aCGRP-IRs These participants are also required to have a history of unsuccessful treatment with 3 small molecule migraine preventive treatments from different classes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None