Ignite Creation Date:
2024-05-06 @ 2:03 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01958125
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2013-10-04
Brief Title:
A Randomized Multicentre Study for the Acute Relief of Episodic and Chronic Cluster Headache
Sponsor:
ElectroCore INC
Organization:
ElectroCore INC
Study Overview
Official Title:
A Randomized Multicentre Double-blind Parallel Sham-controlled Study of GammaCore a Non-invasive Neurostimulator Device for the Acute Relief of Episodic and Chronic Cluster Headache
Status:
COMPLETED
Status Verified Date:
2019-02
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:
The study will look at a non-invasive treatment for people suffering with chronic and episodic headaches Study subjects will be randomized to an active treatment or an in-active treatment for 2 weeks After the 2 weeks all subjects will continue to treat with an active treatment for an additional 2 weeks
Detailed Description:
The study is a prospective double blind randomized sham-controlled multi-center investigation designed for comparison of two parallel groups GammaCore active treatment and a sham in-active treatment The study period begins with a 1-week run-in period followed by a 2 week comparative period when the subjects are randomized 11 to either active treatment or sham in-active treatment The comparative period will be followed by an open label 2 week period where the subjects in the sham treatment group will switch in treatment assignment and receive an active treatment and the active group will continue to receive an active treatment
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