Prevention and Acute Treatment of Chronic Cluster Headache Compared to Standard of Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Multicenter Study for the Prevention and Acute Treatment of Chronic Cluster Headache Using Gammacore, Versus Standard of Care.|
- A Change in the Frequency of Cluster Headache Attacks Per Week [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
- Pain Relief of Headache Attacks [ Time Frame: baseline (2 weeks) and random period(last 2 weeks) ] [ Designated as safety issue: No ]
The median pain during baseline (2 weeks) will be compared with the last 14 days of the treatment period Scale 0-4 0= no pain
- mild pain
- moderate pain
- severe pain
- very severe pain
- Adverse Events [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]The frequency of device effects will be compared between the two treatment groups. Only effects which are new after baseline or have increased severity after baseline will be used in the comparison.
- EQ-5D-3L (EuroQoL 5 Questions and 3 Answering Levels) and a VAS (Visual Analogue Scale) [ Time Frame: 10 weeks (baseline 2 weeks, random 4 weeks and open label 4 weeks) ] [ Designated as safety issue: No ]
The EQ-5D-3L (EuroQoL 5 questions and 3 answering levels) during the run-in period will be compared with the EQ-5D-3L during the treatment period. And treatment period will be compared to open label.
Rating of questions Level 1 no problems Level 2 some problems Level 3 Significant problems Worst case is 15 points and best case is 5 points using index
Visual analogue scale VAS 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state
|Study Start Date:||October 2012|
|Study Completion Date:||October 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
No Intervention: Standard of care
No intervention, standard of care
Active Comparator: GammaCore
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.
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 1:1. The comparative period will be followed by a period where all subject will receive GammaCore® for 4 weeks.After 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701245
|University Department of Neurology CHR|
|Liège, Belgium, B-4000|
|Hufelandstr. 26, Essen, Germany, D-45147|
|Neurologische Klinik und Poliklinik|
|Berlin, Germany, D-10117|
|Krankenhaus Lindenbrunn, Department of Neurology|
|Coppenbrügge, Germany, D-31863|
|Migräne- und Kopfschmerzklinik Königstein|
|Königstein im Taunus, Germany, D-61462|
|Department of Neurology, University of Munich|
|Munich, Germany, D-813 77|
|Regional Referral Headache Centre Sant' Andrea Hospital|
|Rome, Italy, IT-00189|
|The Southern Hospital, Neurology Department|
|Glasgow, Scotland, United Kingdom, G51 4TF|
|Hull Royal Infirmary, Neurology Department|
|Hull, United Kingdom, HU3 2JZ|
|The Walton Centre, Neurology Department|
|Liverpool, United Kingdom, L9 7LJ|
|Principal Investigator:||Charly Gaul, Dr med||Migräne- und Kopfschmerzklinik Königstein|