Phase 2
N=97
Prevention and Acute Treatment of Chronic Cluster Headache Compared to Standard of Care
Chronic Cluster Headache
Bottom Line
View on ClinicalTrials.gov: NCT01701245 ↗Enrolled (actual)
97
Serious AEs
4.1%
Results posted
Apr 2016
Primary outcome: Primary: A Change in the Frequency of Cluster Headache Attacks Per Week — -2.0; -7.6 CH attacks per week
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GammaCore (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ElectroCore INC
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY A Change in the Frequency of Cluster Headache Attacks Per Week |
-2.0; -7.6 | — |
| SECONDARY Pain Relief of Headache Attacks |
2; 1; 3; 1; 16; 8 | — |
| SECONDARY Adverse Events |
6; 9; 2; 1; 0; 1 | — |
| SECONDARY EQ-5D-3L (EuroQoL 5 Questions and 3 Answering Levels) and a VAS (Visual Analogue Scale) |
-0.049; 0.145; 0.078; 0.155; 0.27; 9.20 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Signed Informed Consent Form 2. Subjects between the age of 18-70, both genders 3. Subjects diagnosed with chronic cluster headache for at least 1 year, without remission periods or with remission periods lasting 1 year without remission periods or with remission periods lasting < 1 month.
- Has minimum mean attack frequency of 4 CH attacks per week. 5. Is able to distinguish CH from other headaches (i.e. tension-type headaches).
- Is capable of completing headache pain self-assessments. 7. Agrees to use the GammaCore® device as intended and follow all of the requirements of the study, including follow-up visit requirements.
- Is willing to keep all concomitant medication stable during the entire study period.
- Women of child-bearing potential must use 2 methods of contraceptive i.e. hormones and condom.
Exclusion Criteria
- Is currently taking CH prophylactic medication for indications other than CH which in the opinion of the clinician may interfere with the study
- Has had a change in type or dosage of prophylactic headache medications < 1 month prior to enrollment
- Has a history of intracranial or carotid aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
- Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the GammaCore® treatment site.
- Has other significant pain problem that might confound the study assessments in the opinion of the investigator.
- Has 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 (within 5years).
- Has had a previous unilateral or bilateral vagotomy.
- Has uncontrolled high blood pressure.
- 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.
- Has a history of carotid endarterectomy or vascular neck surgery on the right side.
- Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore® stimulation site.
- Has a history, the last 12 month, of syncope.
- Has a history, the last 12 month of seizures.
- Has a known history or suspicion of substance abuse or addiction, or overuse of acute headache medication for headaches other than CH.
- Has psychiatric or cognitive disorder and/or behavioral problems which in the opinion of the investigator may interfere with the study
- In the opinion of the investigator the subject is incapable of operating the GammaCore® device as intended and performing the data collection procedures.
- Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
- Woman who are pregnant or lactating.
Data sourced from ClinicalTrials.gov (NCT01701245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.