Ignite Creation Date:
2024-05-06 @ 12:59 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01701245
Status:
COMPLETED
Last Update Posted:
2016-04-25
First Post:
2012-10-03
Brief Title:
Prevention and Acute Treatment of Chronic Cluster Headache Compared to Standard of Care
Sponsor:
ElectroCore INC
Organization:
ElectroCore INC
Study Overview
Official Title:
A Randomized Multicenter Study for the Prevention and Acute Treatment of Chronic Cluster Headache Using Gammacore Versus Standard of Care
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Subjects enrolled into this 10 week study will for the first two weeks document the number of cluster headaches and the means of treating medication of these attacks Subjects will then be randomized to into either two groups The first group is continuing with standard of care and the second group is treatment with the investigational device GammaCore for a period of 4 weeks After this 4 week period all subjects will treat with the GammaCore for another 4 week period It is hypothesized the the treatment group will have a reduction in mean cluster headaches per week by 50 compared to the standard of care group
Detailed Description:
The study is a prospective randomized controlled multi-center investigation designed for comparison of two parallel groups GammaCore active treatment and Standard of Care SoC control The study period begins with a 2 week run-in period followed by a 4 week comparative period when the subjects are randomized to either active treatment or control 11 The comparative period will be followed by a period where all subject will receive GammaCore for 4 weeksAfter the subject signed the Consent Form for participation the baseline visit1 data will be collected Subject will be informed how to complete the 2 week diary during the run-in period During the run-in period all subjects will use stable SoC according to their individual prescriptions The subject will record as CH attack regarding duration and frequency and the use of medication and oxygen
Once subjects have finalized the run-in period they are randomized to continue in 4 weeks comparative period During this period the control group continues with stable SoC and the active group is provided with a GammaCore device for prophylactic and acute treatment in addition to the stable SoC Subjects stimulate 3 x 2 times daily as part of the prophylactic treatment regimen cervical vagal nerve Three 90 second stimulations are self-administered by the subject with 5 minutes between each stimulation on the right side of the neck
This preventive stimulation regimen is performed
First Daily Treatment - within 1 hour of waking
Second Daily Treatment - 7-10 hours following the first daily treatment
Acute CH attack
3 x 90 second treatments consecutively at the onset of pain or symptoms If the attack is not aborted within 15 minutes the subject should be informed to take SOC abortive medication
If an acute cluster headache attack is treated with the GammaCore device the subject will try to work within the preventive treatment window to avoid a preventive treatment in the 2-hour refractory period following the acute treatment
A total of minimally 6 stimulations for the preventive part and as needed for the acute attacks The active group also continues with the stable SoC during the entire 4 weeks period Both groups record all CH attacks in the diary together with medication and oxygen use All adverse events shall also be recorded in the diary
The end of the 4 week comparative period marks the completion of the randomized part of the study however all subjects are provided the option to continue to a 4 week GammaCore treatment with the same stimulation parameter as during the 4 week randomization period All subjects randomized to the SoC group will receive training
During the entire study period subjects are allowed to take rescue medication including oxygen inhalation for abortion of CH attacks The amount and doses of the medication and oxygen are recorded in the diary
Once subjects have finalized the run-in period they are randomized to continue in 4 weeks comparative period During this period the control group continues with stable SoC and the active group is provided with a GammaCore device for prophylactic and acute treatment in addition to the stable SoC Subjects stimulate 3 x 2 times daily as part of the prophylactic treatment regimen cervical vagal nerve Three 90 second stimulations are self-administered by the subject with 5 minutes between each stimulation on the right side of the neck
This preventive stimulation regimen is performed
First Daily Treatment - within 1 hour of waking
Second Daily Treatment - 7-10 hours following the first daily treatment
Acute CH attack
3 x 90 second treatments consecutively at the onset of pain or symptoms If the attack is not aborted within 15 minutes the subject should be informed to take SOC abortive medication
If an acute cluster headache attack is treated with the GammaCore device the subject will try to work within the preventive treatment window to avoid a preventive treatment in the 2-hour refractory period following the acute treatment
A total of minimally 6 stimulations for the preventive part and as needed for the acute attacks The active group also continues with the stable SoC during the entire 4 weeks period Both groups record all CH attacks in the diary together with medication and oxygen use All adverse events shall also be recorded in the diary
The end of the 4 week comparative period marks the completion of the randomized part of the study however all subjects are provided the option to continue to a 4 week GammaCore treatment with the same stimulation parameter as during the 4 week randomization period All subjects randomized to the SoC group will receive training
During the entire study period subjects are allowed to take rescue medication including oxygen inhalation for abortion of CH attacks The amount and doses of the medication and oxygen are recorded in the diary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None