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Multi-center, prospective, double-blind, randomized, sham-controlled pivotal study of non-invasive vagus nerve stimulation with the GammaCore® device for the acute treatment of cluster headache. The study compares the safety and effectiveness of an active treatment (GammaCore) against a sham treatment.
Full description
Phase 1: Prospective, randomized (1:1 active treatment:sham control allocation), double blinded, sham controlled treatment (active or sham) phase
Phase 2: Prospective, non-randomized, active treatment phase.
Phase 1 - Two Arms:
Phase 2 - One Arm:
Active Treatment with the GammaCore Device
Enrollment
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Volunteers
Inclusion criteria
Is between the ages of 18 and 75 years.
Has been diagnosed with cluster headache, in accordance with the ICHD-2
Classification criteria (2ndEd):
o At least 5 attacks fulfilling the following criteria:
currently experiencing cluster headaches, and from clinical history is expected to continue experiencing cluster headaches for a period of at least 4 weeks.
able to distinguish CH from other headaches (i.e. migraine, tension-type headaches).
capable of completing headache pain self-assessments.
[Intentionally left blank].
Agrees to use the GammaCore device as intended and follow all of the requirements of the study, including follow-up visit requirements.
Agrees to record usage of the GammaCore device, all required study data, and report any adverse device effects to the study center within 24 hours of any such adverse device effects.
able to provide written Informed Consent
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
150 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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