A Randomized, Multicenter Study for the Prevention and Acute Treatment of Chronic Cluster Headache Using Gammacore, Versus Standard of Care.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 20
- 主要终点
- A Change in the Frequency of Cluster Headache Attacks Per Week
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form
- •Subjects between the age of 18-70, both genders
- •Subjects diagnosed with chronic cluster headache for at least 1 year, without remission periods or with remission periods lasting <1 month, in accordance with the ICHD-II classification criteria (2ndEd):
- •a. At least 5 attacks fulfilling the following criteria: i. Severe or very severe unilateral orbital, supraorbital and/or temporal pain lasting 15-180 minutes if untreated ii. Headache is accompanied by at least 1 of the following:
- •Ipsilateral conjunctival injection and/or lacrimation
- •Ipsilateral nasal congestion and/or rhinorrhea
- •Ipsilateral eyelid oedema
- •Ipsilateral forehead and facial sweating
- •Ipsilateral miosis and/or ptosis
- •A sense of restlessness or agitation iii. Attacks have a frequency from 1 every other day to 8 per day and are not attributed to another disorder iv. Attacks recur over > 1 year without remission periods or with remission periods lasting < 1 month.
- •Has minimum mean attack frequency of 4 CH attacks per week.
- •Is able to distinguish CH from other headaches (i.e. tension-type headaches).
- •Is capable of completing headache pain self-assessments.
- •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.
排除标准
- •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.
结局指标
主要结局
A Change in the Frequency of Cluster Headache Attacks Per Week
时间窗: 4 weeks
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.
次要结局
- Adverse Events(10 weeks)
- Pain Relief of Headache Attacks(baseline (2 weeks) and random period(last 2 weeks))
- EQ-5D-3L (EuroQoL 5 Questions and 3 Answering Levels) and a VAS (Visual Analogue Scale)(10 weeks (baseline 2 weeks, random 4 weeks and open label 4 weeks))