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New treatment option for Relapsing Remitting Multiple Sclerosis
Official title The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study
ClinicalTrials.gov ID: NCT06796504
What this study is testing
What is Disease-Modifying Therapies (DMTs)?
Disease-Modifying Therapies (DMTs) is an investigational medicine, being studied as a potential treatment for relapsing remitting multiple sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 50
You may be able to join if
- Age 22-50 years at informed consent.
- Diagnosis of RRMS by revised 2017 McDonald criteria.
- Latency delay \>118 milliseconds on baseline full-field transient pattern reversal visual evoked potential (VEP) in at least one eye. Both eyes can...
- 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
You likely can't join if
- Confounding ophthalmologic disease or impairments/conditions that could interfere with visual testing (e.g., cataracts, disc hemorrhage, macular...
- 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.
- Documented optic neuritis in the qualifying eye greater than 5 years before screening.
- Steroid treatment for MS symptoms in the 30 days prior to consent
See the full eligibility criteria
- Age 22-50 years at informed consent.
- Diagnosis of RRMS by revised 2017 McDonald criteria.
- Latency delay \>118 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 .
- 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...
- 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. If intermediate-potency DMT, the DMT must have been started and maintained for at least two years prior to consent. If high-potency...
- Score of 2.5 to 6.0 by Expanded Disability Status Scale (EDSS) at baseline, with at least of 2 on the functional systems pyramidal function.
- 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...
- 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.
- Documented optic neuritis in the qualifying eye greater than 5 years before screening.
- Steroid treatment for MS symptoms in the 30 days prior to consent
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- Plymouth, Minnesota, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Morgantown, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Baltimore, Maryland, United States; Plymouth, Minnesota, United States; Houston, Texas, United States; Seattle, Washington, United States; Morgantown, West Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.