The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 9
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The MS pilot study will assess the safety and investigate the remyelinating effects of the SetPoint System (study device) in adult patients diagnosed with relapsing-remitting multiple sclerosis (RRMS). The SetPoint System is intended for adjunctive use with standard of care therapy for RRMS. The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll up to 60 participants at up to 10 sites. All eligible participants will undergo the implant procedure. Two-thirds of the participants will receive active stimulation (treatment) and the one-third will receive non-active stimulation (control). Following treatment evaluations at Week 48, there will be a one-way crossover of control subjects to active stimulation and a 48-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.
详细描述
The MS pilot study is a 2:1 randomized, double-blind, sham-controlled, multi-center pivotal study enrolling up to 60 subjects at up to 10 study centers across the U.S. The study will assess the safety and investigate the remyelinating effects of the SetPoint System (study device) in adult patients diagnosed with relapsing-remitting multiple sclerosis (RRMS). The SetPoint System is intended for adjunctive use with standard of care therapy for RRMS. The study device contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). The implant delivers a small amount of electricity (stimulation) to the nerve. All eligible subjects will undergo the surgery under general anesthesia. Two-thirds of the subjects will receive active stimulation (the treatment group) and the other one-third will receive non-active stimulation (the control group). Stimulation will be delivered for 1 min once per day for 48 weeks. Following treatment evaluations at Week 48, there will be a one-way crossover of control subjects to active stimulation and a 48-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety. Blinding will be maintained for each individual participant until that participant has completed their Week 48 assessments.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22-60 years at informed consent.
- •Diagnosis of RRMS by revised 2017 McDonald criteria.
- •MS disease duration does not exceed 15 years from date of diagnosis at the time of informed consent
- •Latency delay >116 milliseconds on baseline full-field transient pattern reversal visual evoked potential (VEP) in at least one eye. Both eyes can be included if they meet all inclusion criteria.Patients who do not meet the absolute P100 latency threshold of 116 ms in either eye will qualify if they have an inter-eye difference in P100 latency of >6 ms
- •Peri-papillary retinal nerve fiber layer (pRNFL) > 70 microns on Optical Coherence Topography (OCT) in the VEP-qualifying eye (sufficient axons).
- •Best corrected high-contrast (HCVA) better than 20/200 Snellen equivalent or letter score of 35
- •Best corrected low-contrast letter acuity (LCLA) by Sloan chart (2.5% black on white) of no better than 40 letters in the VEP-qualifying eye (Snellen equivalent of 20/40). (Best corrected LCLA must be worse than best corrected HCVA.)
- •Absence of clinical relapse for at least 12 months prior to informed consent
- •No new lesions or increase in existing lesion volume on most recent clinic brain MRI (must be within 1 year of consent)
- •Taking a stable regimen of disease-modifying therapy (DMT) prior to informed consent. The DMT must have been started and maintained at least one year prior to consent.
- •Score of 2.5 to 6.5 by Expanded Disability Status Scale (EDSS) at baseline.
排除标准
- •Confounding ophthalmologic disease or impairments/conditions that could interfere with visual testing (e.g., cataracts, disc hemorrhage, macular star, cotton wool spots, macular degeneration, glaucoma, diabetic and/or hypertensive retinopathy, history of detached retina, etc.)
- •Severe myopia defined as a refractive error of -6.00 diopters or more
- •Concurrent neurological disorders, including known moderate or severe cervical myelopathy.
- •Clinical optic neuritis within 6 months before screening.
- •Steroid treatment for MS symptoms in the 30 days prior to consent
- •Body Mass Index >40 kg/m2
- •Hypersensitivity/allergy to MRI contrast agents and/or unable to perform MRI (e.g., claustrophobia).
- •Regular use of or dependency on nicotine products within the past year.
- •Not a surgical candidate.
研究组 & 干预措施
Treatment
Active stimulation for 1 minute once per day
干预措施: Disease-Modifying Therapies (DMTs) (Drug)
Control
Non-active stimulation for 1 minute once per day
干预措施: Disease-Modifying Therapies (DMTs) (Drug)
Control
Non-active stimulation for 1 minute once per day
干预措施: Implant Procedure (Procedure)
Control
Non-active stimulation for 1 minute once per day
干预措施: Non-active stimulation (Device)
Treatment
Active stimulation for 1 minute once per day
干预措施: Implant Procedure (Procedure)
Treatment
Active stimulation for 1 minute once per day
干预措施: Active stimulation (Device)
结局指标
主要结局
Incidence of adverse events
时间窗: Informed consent through Week 96
All adverse events from Screening through Week 96 (end of study) will be tabulated.
次要结局
未报告次要终点