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NCT06796504 · ClinicalTrials.gov registry record · NA
The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study
A NA study of Relapsing Remitting Multiple Sclerosis, sponsored by SetPoint Medical Corporation.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT06796504 is a NA study of Relapsing Remitting Multiple Sclerosis that is actively recruiting participants, run by SetPoint Medical Corporation. The registered enrollment target is 60 participants, below the 200-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (70% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT06796504, a NA study of Relapsing Remitting Multiple Sclerosis, is actively recruiting participants, sponsored by SetPoint Medical Corporation.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study Summary
The MS pilot study will assess the safety and investigate the remyelinating effects of the SetPoint System (study device) in adult patients with 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.
Conditions Studied
Interventions
- PROCEDURE Procedure/Surgery: Implant Procedure
- DRUG Disease-Modifying Therapies (DMTs)
- DEVICE Device: Active stimulation
- DEVICE Device: Non-active stimulation
Study Locations (3)
Georgia
- Shepherd Center - Atlanta
Washington
- UW Medicine Multiple Sclerosis Center-Northwest - Seattle
West Virginia
- West Virginia University - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-03-31 |
| Est. Completion | 2030-09-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06796504
The ClinicalTrials.gov registry entry for NCT06796504 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 200-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (70% lower). The listed sponsor is SetPoint Medical Corporation, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Relapsing Remitting Multiple Sclerosis appearing as the primary indexed condition, and to 4 interventions - of which Procedure/Surgery: Implant Procedure is the first listed.
NCT06796504 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Georgia, Washington, West Virginia.
Frequently Asked Questions
What is clinical trial NCT06796504 about?
NCT06796504 is a clinical study titled "The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study". The MS pilot study will assess the safety and investigate the remyelinating effects of the SetPoint System (study device) in adult patients with patients diagnosed with relapsing-remitting multiple sclerosis (RRMS). The SetPoint System is intended for adjunctive use with standard of care therapy for...
What is the current status of trial NCT06796504?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2026-03-31. Estimated completion is 2030-09-30.
What conditions does trial NCT06796504 study?
This clinical trial studies the following conditions: Relapsing Remitting Multiple Sclerosis.
What interventions are being tested in trial NCT06796504?
The interventions under investigation include: Procedure/Surgery: Implant Procedure (PROCEDURE), Disease-Modifying Therapies (DMTs) (DRUG), Device: Active stimulation (DEVICE), Device: Non-active stimulation (DEVICE).
Who is sponsoring clinical trial NCT06796504?
This trial is sponsored by SetPoint Medical Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06796504 being conducted?
This trial has 3 study locations across Georgia, Washington, West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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