Ignite Creation Date:
2024-05-06 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03338920
Status:
TERMINATED
Last Update Posted:
2023-07-24
First Post:
2017-11-07
Brief Title:
Study to Assess the Safety and Efficacy of ONZETRA Xsail for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents
Sponsor:
Currax Pharmaceuticals
Organization:
Currax Pharmaceuticals
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of ONZETRA Xsail Sumatriptan Nasal Powder for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
eDiary data collected not sufficient to utilize in the analysis of protocol endpoints
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be conducted to evaluate the safety and efficacy of sumatriptan nasal powder AVP-825 compared to placebo in the acute treatment of migraine in adolescent participants 12 through 17 years of age
Detailed Description:
This is a Phase 3 multicenter randomized double-blind placebo-controlled study evaluating AVP-825 for the acute treatment of migraine with or without aura in adolescent subjects 12 to 17 years old
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?:
None
Is an FDA AA801 Violation?:
None