Prevention and Acute Treatment of Chronic Cluster Headache Compared to Standard of Care
Condition: Chronic Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Interventional
Phase: Phase 2

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
      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.
    

Intervention name(s): GammaCore
Intervention type(s): Device
Intervention description(s): vagal stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vagus nerve stimulation; vagal nerve stimulation; nVNS; VNS; cluster headache; chronic; non invasive; gammacore