The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-60
SponsorSetPoint Medical Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Implant Procedure
Procedure/SurgeryThe SetPoint System (study device)contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings.
Disease-Modifying Therapies (DMTs)
DrugAll subjects will continue treatment with standard of care disease-modifying therapies for the duration of the study.
Active stimulation
DeviceActive stimulation for 1 minute once per day
Non-active stimulation
DeviceNon-active stimulation for 1 minute once per day
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 3 interventions
Group B: ControlSham comparator 3 interventions
Trial outcomes
Primary outcomes
1
Incidence of adverse events
All adverse events from Screening through Week 96 (end of study) will be tabulated.
Time frame
Informed consent through Week 96Other outcomes
1
Reduction in VEP latency
Change from baseline full-field VEP P100 latency at Week 48.
Time frame
Baseline (Screening) through Week 482
Change in lesion size as detected on MRI
New T2 and/or contrast enhancing lesions Change in T2 lesion volume Change in phase (paramagnetic) rim lesions (PRL) Difference in the occurrence and volume of slowly expanding lesions
Time frame
Baseline (Screening) through Week 483
Change in number of letters accurately read
Change from baseline in LCLA and HCVA at Week 48.
Time frame
Baseline (Screening) through Week 484
Change in the NEI-VFQ-25 score
Change from baseline in NEI-VFQ-25 at Week 48
Time frame
Baseline (Screening) through Week 48Sponsors and contacts
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Source ClinicalTrials.gov