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Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache (CH)

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ClinicalTrials.gov Identifier: NCT01792817
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
ElectroCore INC

February 8, 2013
February 15, 2013
November 24, 2016
May 17, 2018
May 17, 2018
February 2013
June 2014   (Final data collection date for primary outcome measure)
Number of Participants With Repsonse to Treatment [ Time Frame: 15 minutes post stimulation ]

The primary outcome measurement for effectiveness is the rate of responders for the active treatment group, compared to the sham control group.

A responder is defined as a subject who has recorded an intensity of 0 or 1 on the 5-point headache pain scale (no pain, mild, moderate, severe, very severe) at 15 minutes post-initiation of treatment of the first treated cluster headache attack of Phase 1.

Headache pain intensity [ Time Frame: 15 minutes post stimulation ]
The primary outcome measurement for effectiveness is the rate of responders for the active treatment group, compared to the sham control group. A responder is defined as having recorded an intensity of 0 or 1 on the 5-point headache pain scale (no pain, mild, moderate, severe, very severe) at 15 minutes post-initiation of treatment of the first treated cluster headache attack of Phase 1. Use of rescue medications during the first hour after treatment with the GammaCore device will be considered a treatment failure.
Complete list of historical versions of study NCT01792817 on ClinicalTrials.gov Archive Site
  • Sustained Treatment Success at 1 Hour Post-Treatment [ Time Frame: For 1 hour post stimulation ]
    Sustained treatment success at 1 hour post-treatment was defined as having recorded an intensity of 0 or 1 on the 5-point headache pain scale at 15 minutes and 1 hour post-initiation of treatment of the first treated cluster headache attack of Phase 1, and having refrained from use of rescue medications during the full 60 minute period
  • Average Mean Attack Intensities Experienced Per Subject [ Time Frame: 15 minutes post-stimulation ]
    Cluster headache attack intensity was reported on a 5-point scale: no pain, mild, moderate, severe, very severe, whereas no pain =1 is the best outcome and very severe=5 is the worst outcome . The average of all subjects' mean attack intensities experienced at 15 minutes post-initiation of treatment during Phase 1 for the active treatment group, compared to the sham control group. The mean 15-minute scores were calculated for the first five attacks suffered by each subject during Phase 1. For subjects with fewer than five treated attacks, the scores for those available were averaged.
  • Incidence and Occurrence of Serious Adverse Events Related to Active or Sham Study Treatment and / or to Cluster Headache Events. [ Time Frame: 4 weeks, Phase 1 ]
    The primary safety measure for this study is the incidence and occurrence of serious adverse events related to active or sham study treatment and / or to cluster headache events during Phase 1 of the study.
  • Sustained headache intensity pain [ Time Frame: For 1 hour post stimulation ]
    Sustained treatment success at 1 hour post-treatment, defined as having recorded an intensity of 0 or 1 on the 5-point headache pain scale at 1 hour post-initiation of treatment of the first treated cluster headache attack of Phase 1.
  • Average Mean Attack Intensities Experienced Per Subject [ Time Frame: 15 minutes post-stimulation ]
    • The average of all subjects' mean attack intensities experienced at 15 minutes post-initiation of treatment during Phase 1 for the active treatment group, compared to the sham control group. The mean 15-minute score will be calculated for the first five attacks suffered by each subject during Phase 1. For subjects with fewer than five treated attacks, the scores for those available will be averaged; this should lead to less missing data.
  • Incidence and Occurrence of Serious Adverse Events Related to Active or Sham Study Treatment and / or to Cluster Headache Events. [ Time Frame: Duration Phase 1, average of 4 weeks ]
    The primary safety measure for this study is the incidence and occurrence of serious adverse events related to active or sham study treatment and / or to cluster headache events during Phase 1 of the study. Adverse events will be collected and classified by relatedness to the investigational treatment, onset, type, severity and frequency.
Not Provided
  • Mean attack intensity [ Time Frame: Duration of Phase 2, average of 3 months ]
    Mean attack intensity (on a 5-point scale) during Phase 2
  • Mean attack duration [ Time Frame: Duration Phase 1 and 2, average of 4 months ]
    Mean attack duration for each treatment group;
  • Interparoxysmal Pain [ Time Frame: Duration of Phase 1 and 2, average of 4 months ]
    Interparoxysmal pain (on a 5-point scale);
  • Meaningful response of headache pain [ Time Frame: Duration of Phase 1 and 2, average of 4 months ]
    Time to meaningful response, defined as recording of 0 or 1 headache pain intensity on 5-point scale
  • Socioeconomic evaluation [ Time Frame: Duration of Phase 1 and 2, average of 4 months ]
    Socioeconomic evaluation (SF-12 Quality of Life SF-12, EQ5D, days lost from work, etc);
 
Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache
Non-invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Treatment of Cluster Headache
Multi-center, prospective, double-blind, randomized, sham-controlled pivotal study of non-invasive vagus nerve stimulation with the GammaCore® device for the acute treatment of cluster headache. The study compares the safety and effectiveness of an active treatment (GammaCore) against a sham treatment.

Phase 1: Prospective, randomized (1:1 active treatment:sham control allocation), double blinded, sham controlled treatment (active or sham) phase

Phase 2: Prospective, non-randomized, active treatment phase.

Phase 1 - Two Arms:

  1. Active Treatment with the GammaCore Device
  2. Sham Treatment with a placebo device

Phase 2 - One Arm:

Active Treatment with the GammaCore Device

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cluster Headache
  • Device: GammaCore
    Treatment with active gammacore vagus nerve stimulator
  • Device: Sham GammaCore device
    Treatment with sham stimulator
  • Sham Comparator: Sham GammaCore device
    The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.
    Intervention: Device: Sham GammaCore device
  • Experimental: GammaCore Device
    Non-Invasive Vagus Nerve Stimulator
    Intervention: Device: GammaCore
Silberstein SD, Mechtler LL, Kudrow DB, Calhoun AH, McClure C, Saper JR, Liebler EJ, Rubenstein Engel E, Tepper SJ; ACT1 Study Group. Non-Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache: Findings From the Randomized, Double-Blind, Sham-Controlled ACT1 Study. Headache. 2016 Sep;56(8):1317-32. doi: 10.1111/head.12896.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
300
October 2014
June 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Is between the ages of 18 and 75 years.
  2. diagnosed with episodic cluster headache, in accordance with the ICHD-2 Classification criteria (2ndEd):

    o At least 5 attacks fulfilling the following criteria:

    • Severe or very severe unilateral orbital, supraorbital and/or temporal pain lasting 15-180 minutes if untreated
    • Headache is accompanied by at least 1 of the following:
    • Ipsilateral conjunctival injection and/or lacrimation
    • Ipsilateral nasal congestion and/or rhinorrhea
    • Ipsilateral eyelid edema
    • Ipsilateral forehead and facial sweating
    • Ipsilateral miosis and/or ptosis
    • A sense of restlessness or agitation
  3. currently experiencing cluster headaches, and from clinical history is expected to continue experiencing cluster headaches for a period of at least 4 weeks.
  4. able to distinguish CH from other headaches (i.e. migraine, tension-type headaches).
  5. capable of completing headache pain self-assessments.
  6. [Intentionally left blank].
  7. Agrees to use the GammaCore device as intended and follow all of the requirements of the study, including follow-up visit requirements.
  8. Agrees to record usage of the GammaCore device, all required study data, and report any adverse device effects to the study center within 24 hours of any such adverse device effects.
  9. able to provide written Informed Consent

Exclusion Criteria:

  1. had surgery to treat cluster headache.
  2. currently taking prophylactic medication (including chronic opioids and non-prescribed street drugs) for indications other than CH that in the opinion of the clinician may interfere with the study.
  3. [Intentionally left blank].
  4. undergone botulinum toxin injections in the head and/or neck in the last 3 months or nerve blocks (occipital or other) in the head or neck in the last month.
  5. history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
  6. lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the treatment site.
  7. structural intracranial, or cervical vascular lesions that may potentially cause headache attacks.
  8. other significant pain problem (including cancer pain, fibromyalgia, and trigeminal neuralgia/TAC-cluster) that might confound the study assessments.
  9. known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction.
  10. history of prolonged QT interval or a history of clinically significant arrhythmia.
  11. abnormal baseline ECG (e.g. second and third degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction).
  12. previous bilateral or right cervical vagotomy.
  13. uncontrolled high blood pressure.
  14. currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
  15. history of carotid endarterectomy or vascular neck surgery on the right side.
  16. implanted with metal cervical spine hardware or has a metallic implant near the GammaCore stimulation site.
  17. recent or repeated history of syncope.
  18. recent or repeated history of seizure.
  19. known history or suspicion of substance abuse or addiction, or overuse of acute headache medication for headaches other than CH.
  20. psychiatric or cognitive disorder and/or behavioral problems which in the opinion of the clinician may interfere with the study.
  21. pregnant, nursing, thinking of becoming pregnant in the next 4 months, or of childbearing years and is unwilling to use an accepted form of birth control.
  22. participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
  23. Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01792817
CH-US-01
Yes
Not Provided
Plan to Share IPD: Undecided
ElectroCore INC
ElectroCore INC
Not Provided
Study Director: Lia Spitzer ElectroCore INC
ElectroCore INC
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP