NCT01958125

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: ElectroCore INC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (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.

Conditions

• Cluster Headache

Interventions

Type	Name	Description
DEVICE	gammaCore	Vagal stimulation

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-10-01
• Completion: 2015-01-01
• First posted: 2013-10-08
• Last updated: 2019-02-26
• Results posted: 2019-02-26

Locations

9 sites across 4 countries: Denmark, Germany, Netherlands, United Kingdom