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A Randomized Multicentre Study for the Acute Relief of Episodic and Chronic Cluster Headache.

Cluster Headache Clinical Trial

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.

Clinical Trial 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.

Clinical Trial 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 (1:1) 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01958125
Study type Interventional
Source ElectroCore INC
Contact
Status Completed
Phase N/A
Start date August 2013
Completion date January 2015
View Details
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