A randomized, multicentre, double-blind, parallel, sham-controlled study of the gammaCore®, a non-invasive neurostimulator device for the acute relief of episodic and chronic cluster headache.
- Conditions
- cluster headaches10019231
- Registration Number
- NL-OMON40599
- Lead Sponsor
- electroCore LLC
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
Inclusion Criteria
1. Is 18 years or older
2. Has been diagnosed with episodic or chronic cluster headache in accordance with the ICHD-2 Classification criteria (2ndEd)
3. Is capable of completing the 5-point pain scale, disability scale and other self-assessment questionnaires.
4. Agrees to refrain from starting new medication aimed to control the cluster headache for the duration of the run-in and randomized phase
5. Is able to provide written Informed Consent
Exclusion Criteria
Subjects meeting any of the following criteria can not be included in this research study
1. Episodic cluster headache sufferers who are not in a cluster headache bout at the time of screening and enrollment
2. Need to commence treatment with oral or injectable steroids for eventual concomitant medical conditions
3. Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the gammaCore® treatment site
4. Is currently taking medication for indications other than cluster headache that in the opinion of the clinician may interfere with the study
5. Has a history of any cranial aneurysm, intracranial haemorrhage, brain tumours or significant head trauma
6. Diagnosed or suspected secondary headache
7. Has other significant pain problem that might confound the study assessments in the opinion of the investigator
8. Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of transient ischemic attack (TIA) or cerebral vascular accident CVA), congestive heart failure (CHF), known severe coronary artery disease or recent (5 years) myocardial infarction
9. Has an 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)
10. Has had a cervical vagotomy
11. Has uncontrolled high blood pressure
12. Is 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
13. Has a history of carotid endarterectomy or vascular neck surgery
14. Has been implanted with metal cervical spine hardware or has a metallic implant near
the gammaCore stimulation site
15. Has a recent (12 months) or repeated history of syncope
16. Has a recent (12 months) or repeated history of seizures
17. Has a known or suspected history of substance abuse or addiction, or overuse of acute headache medication
18. Has psychiatric or cognitive disorder and/or behavioural problems which in the opinion of the clinician may interfere with the study
19. Is pregnant, nursing, thinking of becoming pregnant during the study period
20. Is participating in any other therapeutic clinical investigation or has participated in a clinical trial within a 30 days period prior to this study
21. Is a relative of or an employee of the investigator or the clinical study site
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>The primary endpoint is pain free rates at 15 minutes comparing active and<br /><br>sham.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>- Change in mean attack duration for each treatment group from the run-in<br /><br>period (baseline) to visit 3 (randomized period)<br /><br>- The reduction in mean disability, will compare the run-in period (baseline)<br /><br>to visit 3 (randomized period) of the two treatment groups<br /><br>- Reduction in mean attack severity from the run-in period (baseline) to visit<br /><br>3 (randomized period)<br /><br>- Pain free rates at 30 minutes<br /><br>- Outcome for QOL questionnaires at V3 and at V4 compared with V2<br /><br>- Dayslost from work at V3 and at V4 compared with V2<br /><br>- Acute rescue treatments or medications at 15 minutes from start of use of<br /><br>the study device between active and sham group.<br /><br>- Subject satisfaction between active and sham group<br /><br>- Number of adverse events between active and sham group</p><br>