Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04921384
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2021-06-04
Brief Title:
Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine
Sponsor:
H Lundbeck AS
Organization:
H Lundbeck AS
Study Overview
Official Title:
Interventional Randomized Double-blind Parallel-group Placebo-controlled Study to Evaluate Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
Sunrise
Brief Summary:
This study evaluates the efficacy of eptinezumab to prevent migraine in participants with chronic migraine
Detailed Description:
This is an interventional multi-regional multi-site randomized double-blind placebo-controlled Phase III study to confirm the efficacy and safety of eptinezumab in participants with chronic migraine who are eligible for preventive treatment
participants will be randomly allocated to one of three treatment groups eptinezumab 300 mg eptinezumab 100 mg or placebo
The double-blind placebo-controlled treatment period will be followed by an extension period where all participants will receive active treatment to further assess the safety and tolerability of eptinezumab
The total study duration from the Screening Visit to the Safety Follow-up Visit is approximately 36 weeks and includes a Screening Period 28-30 days a Placebo-controlled Period 12 weeks an Extension Period 12 weeks and a Safety Follow-up Period 8 weeks
participants will be randomly allocated to one of three treatment groups eptinezumab 300 mg eptinezumab 100 mg or placebo
The double-blind placebo-controlled treatment period will be followed by an extension period where all participants will receive active treatment to further assess the safety and tolerability of eptinezumab
The total study duration from the Screening Visit to the Safety Follow-up Visit is approximately 36 weeks and includes a Screening Period 28-30 days a Placebo-controlled Period 12 weeks an Extension Period 12 weeks and a Safety Follow-up Period 8 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-001657-42 | EUDRACT_NUMBER | None | None |