| NCT ID | NCT07011914 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Multiple Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-10-23 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-10-23 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is structured around three main aims. In Aim 1, investigators will conduct community-based participatory research (CBPR) to develop culturally tailored methods to assess childhood adversity in multiple sclerosis (MS). Aim 2 will investigate the impact of childhood adversity on MS outcomes among individuals with relapsing-remitting MS (RRMS), among whom 70% belong to a group historically under-represented in MS research: Black, Hispanic, or poverty-impacted. Aim 2 procedures involve two visits that include a research blood draw and an MRI scan. In Aim 3, investigators will conduct interviews and surveys to explore environmental and social factors affecting quality of life for minority MS patients.
Eligibility Criteria
Inclusion Criteria: Aim 1 - * aged ≥18-29 years * diagnosis of RRMS (Fulfill international criteria for relapsing remitting (RRMS)) * 70% self-identifying as a Black, Hispanic, or poverty-impacted (up to 138% of the federal poverty level) individual,and * fluent in English or Spanish. Aim 2 - * aged ≥18-29 years * diagnosis of RRMS (Fulfill international criteria for relapsing remitting (RRMS)) * 70% self-identifying as a Black, Hispanic, or poverty impacted, and * fluent reading in English or Spanish * Pediatric onset MS (MS onset before age 18 and age at time of enrollment is 18-25) OR adult-onset MS (MS onset at age 18 or older and age at time of enrollment is 19-29) * Disease duration below 8 years Aim 3 - Aim 3 will enroll the first 20 participants from Aim 2 who meet the following criteria: * completed at least 80% of study data in the cross-sectional study/Aim 2. * a total of 70% must self-identify as Black, Hispanic, or meet criteria for poverty impacted. * interviews will be evenly split between participants with high (top quartile) and low (bottom quartile) of PROMIS-10 scores. Exclusion Criteria: * Primary or Secondary Progressive MS * Inability to consent. * MS relapse within 30 days prior to study entry * Other major neurologic or psychiatric illness
Contact & Investigator
Lauren Krupp, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT07011914 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07011914 currently recruiting?
Yes, NCT07011914 is actively recruiting participants. Contact the research team at Taj.Adams@nyulangone.org for enrollment information.
Where is the NCT07011914 trial being conducted?
This trial is being conducted at Birmingham, United States, San Francisco, United States, Aurora, United States, Boston, United States and 2 additional locations.
Who is sponsoring the NCT07011914 clinical trial?
NCT07011914 is sponsored by NYU Langone Health. The principal investigator is Lauren Krupp, MD at NYU Langone Health. The trial plans to enroll 300 participants.
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