A Phase IV Post Marketing Surveillance Study to Evaluate the Safety and Efficacy of Nerivioâ„¢, a Neuromodulation Device, for the acute treatment of episodic and chronic Migraine.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 20
- 主要终点
- Reduction of migraine pain at 2 hours:
研究概览
简要总结
Nerivioâ„¢, a neurostimulation device, is intended for the acute and prophylactic treatment of migraine with or without aura in patients 12 years or older.
The device delivers transcutaneous electrical stimulation below the pain threshold to the patient’s upper arm. The level of generated stimuli is similar to other FDA-approved electro-stimulation devices. The treatment is self-administered and controlled by a dedicated smartphone application. It is believed to alleviate pain through conditioned pain modulation.
This is a prospective, single arm, multicentric, open label trial in which At least 200 subjects will be enrolled as per the inclusion criteria, and Objectives of this study is to demonstrate the safety and effectiveness of Nerivioâ„¢ device for the acute treatment of episodic and chronic Migraine.
This study will be conducted in two stages:
Stage One – Enrollment and Training:
The first visit will include screening, enrollment and training on the device. The enrollment and device training may occur in two separate visits instead of one.
Subjects with a history of episodic or chronic migraine (as per inclusion criteria) (1) with or without aura, with no complication (i.e., Status migrainosus, Persistent aura without infarction, Migrainous infarction, Migraine aura-triggered seizure), who met the International Classification of Headache Disorders (ICHD-3 Section 1, Diagnostic Criteria for Migraine) (2) will be included.
First visit:
The first visit will include screening, enrollment and training on the application. Eligible participants will be trained to use the Nerivioâ„¢ device, associated smartphone app and migraine diary. Subjects will be asked to complete the diary at the enrollment visit by recalling events of
their migraine attacks for the last one month. They will be trained to capture data on the trial diary. (3) Device instructions for use will be available in a separate document which will be provided to the participants with the Nerivioâ„¢ device.
Stage Two - Single-arm, open-label treatment stage:
Following successful completion of training, subjects will be asked to apply the device and administer treatment for every migraine attack they experience. At the onset of their migraine attack, subjects will report the results of every treatment using the migraine diary.
Final visit: End of study:
Participants will return the device to the clinic following the end of the study.
Duration for each subject will be approximately one- month of treatment or up to four qualified migraine attacks (whichever is achieved first).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 12-75 years old
- •Meeting the ICHD-3 diagnostic criteria for migraine with or without aura.
- •Participants must be on a stable dose of a single migraine preventive medication during the 2 months before enrollment.
- •Must be able and willing to comply with the protocol.
- •Must be able and willing to provide written informed consent.
排除标准
- •Use of antipsychotics on a regular basis during the 3 months prior to consideration for enrolment.
- •Having implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nervestimulator).
- •Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
- •Known uncontrolled epilepsy.
- •Any use of Cannabis, including medical use.
- •Has undergone nerve block (occipital or other) in the head or neck within the last 2 weeks.
- •Change in oral migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the study.
- •Subject is participating in any other clinical study.
- •Not having the basic cognitive and motor skills needed tooperate a smartphone.
- •Pregnant, or trying to get pregnant or breastfeeding female participants. Details regarding UPT (Urine Pregnancy Test) results must be documented.
- •Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments.
- •Subject is experiencing a menstrually-related migraine.
- •Received OnabotulinumtoxinA/any botulinum toxin injections, parenteral infusions for migraine within the previous 3 month.
- •Subject participated in a previous study with the Nerivio device.
- •Subject with arm circumference below 7.9 inches (20 cm). Note.
- •Females of childbearing potential must have a negative pregnancy test and must be willing to use adequate contraception during the study.
结局指标
主要结局
Reduction of migraine pain at 2 hours:
时间窗: 2 hours post treatment
Proportion (%) of subjects reporting reduction in their pain level 2 hours post-treatment without rescue medications from severe or moderate to mild or no pain, or from mild to no pain, in their second treated migraine attack (excluding the first treatment).
时间窗: 2 hours post treatment
次要结局
- Freedom from most bothersome migraine-associated symptom (MBS) at 2 hours:(Proportion (%) of subjects reporting, 2 hours post-treatment, freedom from their MBS other than a headache, in their second treated migraine attack. MBS may be nausea, or vomiting or photophobia, or phonophobia or combination of them −as defined by each subject at the beginning of the treatment.)
- Pain and MBS relief at 2 hours:(Proportion (%) of subjects reporting post-treatment response to both the primary and the first secondary endpoints at 2 hours post- treatment.)
- Pain-free at 2 hours:(Proportion (%) of subjects reporting freedom from migraine pain at 2 hours post-treatment without rescue medications in their second)
- Rescue medications use within 2 hours:(Proportion (%) of subjects reporting use of rescue/acute medication within 2 hours post-treatment in their second treated migraine attack.)
- Sustained MBS freedom at 24 hours:(Proportion (%) of subjects reporting post-treatment response to the first secondary endpoints at 24 hours.)
- Sustained pain and MBS Relief at 24 hours:(Proportion (%) of subjects reporting post-treatment response to both the primary and the first secondary endpoints at 24 hours.)
- Sustained pain-free at 24 hours with a single use of the device: Proportion (%) of subjects reporting pain-free at 2 hours, and no return of any pain or use of rescue/acute medication, or reuse of device between 2 hours and 24 hours, in their second treated migraine attack.(2-24 hours post treatment)
- Rescue medications use between 2-24 hours:(Proportion (%) of subjects reporting use of rescue/acute medication between 2- and 24-hours post-treatment in their second treated migraine attack.)
- Within-subject consistency of the primary endpoint in subsequent treatments:(The repeatability of migraine headache reduction, as described in the primary endpoint definition, in subsequently treated attacks.)
研究者
Dr Esha Singh
Mediception Science Pvt Ltd