Neurofilament light chains (NFL) in serum in multiple sclerosis for the detection of high risk of disease progression

Neurofilament light chains (NFL) in serum in multiple sclerosis for the detection of high risk of disease progression - NEDA3-NFLhigh-Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032567

Enrollment

2000

Registered

2023-09-13

Start date

2023-09-25

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G35

Interventions

Group 1: MS patients meeting NEDA3 criteria with an NFL z-score>=1.5. - Intensified observation for 2 years: blood sampling every 3 months, MRI examinations every 6 months, and physical and neurolog

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Clinically-isolated syndrome or multiple sclerosis according to current McDonald criteria.

Exclusion criteria

Exclusion criteria: - Factors that contraindicate follow-up examinations as part of the study, e.g., existing pregnancy, florid alcohol abuse, cardiac pacemaker, claustrophobia, implants not capable of MRI - Patient not capable of giving consent

Design outcomes

Primary

Measure	Time frame
Can NFL predict disease progression(EDA) in NEDA-3 patients.	—

Secondary

Measure	Time frame
Can NFL predict PIRA, therapy escalation, MRI changes (T1 black holes, smoldering lesions, brain atrophy).	—

Countries

Germany

Contacts

Public ContactStefan Bittner

Klinik und Poliklinik für Neurologie, Universitätsmedizin Mainz

stefan.bittner@unimedizin-mainz.de06131172805

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026