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GammaCore · 1 trial · 1 indication
The primary endpoint is the reduction in mean number of CH attacks per week. The number of CH attacks will be calculated as the sum of all attacks over the days in the run-in period and divided by the number of weeks, respectively for the last 14 days of treatment during the randomised phase. The reduction will then be the number of CH attacks during treatment period (last 14 days of the randomized treatment period) - number of CH attacks during run-in.
| Arm | Type | Description |
|---|---|---|
| Standard of care | NO_INTERVENTION | No intervention, standard of care |
| GammaCore | ACTIVE_COMPARATOR | Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack. |
| Name | Type | Description |
|---|---|---|
| GammaCore | DEVICE | vagal stimulation |
Inclusion Criteria: 1\. Signed Informed Consent Form 2. Subjects between the age of 18-70, both genders 3. Subjects diagnosed with chronic cluster headache for at least 1 year, without remission periods or with remission periods lasting \<1 month, in accordance with the ICHD-II classification crite...
GammaCore is an investigational therapy being studied for the prevention and acute treatment of Chronic Cluster Headache. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The therapy is being evaluated in a clinical trial setting to assess its safety and efficacy for this condition.
GammaCore is being developed by electroCore, Inc., a biopharmaceutical company. The company is conducting clinical research to evaluate the therapy for Chronic Cluster Headache. electroCore, Inc. is publicly traded under the ticker symbol ECOR.
GammaCore is in Phase 2 clinical development for Chronic Cluster Headache. It is an investigational therapy, meaning it has not yet received regulatory approval. The Phase 2 trial has been completed, and the therapy remains under investigation for this indication.
GammaCore has one completed Phase 2 clinical trial registered as NCT01701245, titled 'Prevention and Acute Treatment of Chronic Cluster Headache Compared to Standard of Care.' The trial enrolled 97 participants across Belgium, Germany, Italy, and the United Kingdom, and included adults aged 18 years and older.
GammaCore is not FDA approved for Chronic Cluster Headache. It is an investigational therapy currently in Phase 2 clinical development. The completed clinical trial has evaluated its use, but regulatory approval has not been granted, and it remains under investigation.