Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01701245 | Prevention and Acute Treatment of Chronic Cluster Headache Compared to Standard of Care | PHASE2 | COMPLETED | 97 | — | — | Oct 1, 2012 | Oct 1, 2014 | Apr 25, 2016 | 10 | Belgium, Germany +2 |
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...