Prevention and Acute Treatment of Chronic Cluster Headache Compared to Standard of Care
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.
|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.|
- Decrease 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: 10 weeks ] [ Designated as safety issue: No ]The mean pain during run-in will be compared with both the pain relief the last 14 days of the treatment period and the pain relief during the whole treatment period.
- 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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]The EQ-5D-3L during the run-in period will be compared with the EQ-5D-3L during the treatment period.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||January 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
|Contact: Annelie Anderson||+46 (0) 721 firstname.lastname@example.org|
|University Department of Neurology CHR||Recruiting|
|Liège, Belgium, B-4000|
|Contact: Delphine Magis, Dr +32 4230 7811 email@example.com|
|Contact: Pascale Gerard, SC +32 4 225 63 91 firstname.lastname@example.org|
|Principal Investigator: Delphine Magis, MD|
|Hufelandstr. 26, Essen, Germany, D-45147|
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|Sub-Investigator: Steffen Nägel, MD|
|Sub-Investigator: Maja Bak, MD|
|Neurologische Klinik und Poliklinik||Recruiting|
|Berlin, Germany, 10117|
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|Contact: Heike Israel-Willner, MD +49 030 8445-0 Heike.Israel@charite.de|
|Principal Investigator: Uwe Reuter, Dr|
|Sub-Investigator: Lars Neeb, MD|
|Sub-Investigator: Heike Israel-Willner, MD|
|Krankenhaus Lindenbrunn, Department of Neurology||Recruiting|
|Coppenbrügge, Germany, D-31863|
|Contact: Stefan Evers, Prof +49 (0) 5156-782290 firstname.lastname@example.org|
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|Migräne- und Kopfschmerzklinik Königstein||Recruiting|
|Königstein im Taunus, Germany, D-61462|
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|Department of Neurology, University of Munich||Recruiting|
|Munich, Germany, D-813 77|
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|Contact: Ozan Eren, MD +49 89 7095 3900 Ozan.Eren@med.uni-muenchen.de|
|Principal Investigator: Andreas Straube, Prof.|
|Sub-Investigator: Ruth Ruscheweyh, MD|
|Sub-Investigator: Ozan Eren, MD|
|Regional Referral Headache Centre Sant' Andrea Hospital||Recruiting|
|Rome, Italy, IT-00189|
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|Contact: Andrea Negro, MD +39 339 156 3982 email@example.com|
|Principal Investigator: Paolo Martelletti, Prof|
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|The Southern Hospital, Neurology Department||Recruiting|
|Glasgow, Scotland, United Kingdom, G51 4TF|
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|Contact: Anissa Benchiheub, SC +44 (0)1412 329515 email@example.com|
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|Hull Royal Infirmary, Neurology Department||Recruiting|
|Hull, United Kingdom, HU3 2JZ|
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|The Walton Centre, Neurology Department||Recruiting|
|Liverpool, United Kingdom, L9 7LJ|
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|Sub-Investigator: Helene Banks, MD|
|Principal Investigator:||Charly Gaul, Dr med||Migräne- und Kopfschmerzklinik Königstein|