Non-invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Treatment of Cluster Headache
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cluster Headache
- Sponsor
- ElectroCore INC
- Enrollment
- 150
- Locations
- 20
- Primary Endpoint
- Number of Participants With Repsonse to Treatment
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed 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: 1. Active Treatment with the GammaCore Device 2. Sham Treatment with a placebo device Phase 2 - One Arm: Active Treatment with the GammaCore Device
Investigators
Eligibility Criteria
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:
- •Severe or very severe unilateral orbital, supraorbital and/or temporal pain lasting 15-180 minutes if untreated
- •Headache is accompanied by at least 1 of the following:
- •Ipsilateral conjunctival injection and/or lacrimation
- •Ipsilateral nasal congestion and/or rhinorrhea
- •Ipsilateral eyelid edema
- •Ipsilateral forehead and facial sweating
Exclusion Criteria
- •had surgery to treat cluster headache.
- •currently taking prophylactic medication (including chronic opioids and non-prescribed street drugs) for indications other than CH that in the opinion of the clinician may interfere with the study.
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- •undergone botulinum toxin injections in the head and/or neck in the last 3 months or nerve blocks (occipital or other) in the head or neck in the last month.
- •history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
- •lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the treatment site.
- •structural intracranial, or cervical vascular lesions that may potentially cause headache attacks.
- •other significant pain problem (including cancer pain, fibromyalgia, and trigeminal neuralgia/TAC-cluster) that might confound the study assessments.
- •known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction.
- •history of prolonged QT interval or a history of clinically significant arrhythmia.
Outcomes
Primary Outcomes
Number of Participants With Repsonse to Treatment
Time Frame: 15 minutes post stimulation
The primary outcome measurement for effectiveness is the rate of responders for the active treatment group, compared to the sham control group. A responder is defined as a subject who has recorded an intensity of 0 or 1 on the 5-point headache pain scale (no pain, mild, moderate, severe, very severe) at 15 minutes post-initiation of treatment of the first treated cluster headache attack of Phase 1.
Secondary Outcomes
- Sustained Treatment Success at 1 Hour Post-Treatment(For 1 hour post stimulation)
- Incidence and Occurrence of Serious Adverse Events Related to Active or Sham Study Treatment and / or to Cluster Headache Events.(4 weeks, Phase 1)
- Average Mean Attack Intensities Experienced Per Subject(15 minutes post-stimulation)