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Clinical Trials in Germany / NCT07753928
Enrolling by invitation Observational

MS-Related Disability Worsening and Thalamic Volume Loss

NCT07753928 · tracked via the Priya Life Science Germany tracker
Sponsor
Jung Diagnostics GmbH
Phase
Observational
Started
2022-07-01
Last updated
2026-08-31

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

Disease-Modifying Therapies (DMTs)

Disease-Modifying Therapies (DMTs): Disease-Modifying Therapies (DMTs)

Study summary

PENTAGON is an observational, non-interventional, multicenter, prospective cohort study conducted at approximately 20 neurology centers and affiliated radiology centers across Germany. It investigates whether loss of thalamic volume (TVL) is an independent driver of disability progression in patients with relapsing-remitting multiple sclerosis (MS). The study observes two groups: patients with active MS (receiving or about to receive first- or second-line disease-modifying therapies) and patients with progressive MS. Over a 24-month primary observation period - extendable to 72 months - MS-related disability is measured with the Expanded Disability Status Scale (EDSS), and whole-brain and thalamic volumes are quantified from standardized high-resolution T1-weighted MRI using validated deep-learning methods. The primary objective is to demonstrate that the change in MS-related disability over 24 months is inversely associated with the change in thalamic volume over the same period. No procedures beyond routine clinical care are required.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria: General: Patients aged 15 to 55 with MS diagnosed by the revised 2017 McDonald criteria; ACTIVE MS group: a) Meet one disease-activity criterion: more than 10 T2 lesions at the first visit, OR at least one documented relapse in the 12 months before the first visit, OR ≥1 Gd-enhancing lesion on brain MRI in the prior 12 months, OR ≥1 new or enlarging T2 lesion in the prior 12 months. b) Receiving or about to receive first-line immune therapy (as first or second DMT), e.g., teriflunomide, ozanimod, dimethylfumarate, ponesimod, diroximelfumarate; or receiving or about to receive second-line therapy after prior first-line DMT (e.g., monoclonal antibodies); PROGRESSIVE MS group: a) no relapses in the last two years and progressive disease defined clinically (disability worsening) or by imaging (abnormal whole-brain volume loss); b) participants initially in the active group may switch to the progressive group if they later meet its criteria. Exclusion Criterion: Not eligible to receive MRI.

Primary outcome measure(s)

  • Association between annual change in EDSS and annualized thalamic volume loss (TVL) — months: 0 - 24
    Pearson correlation coefficient between the annual change in EDSS (slope of linear regression of EDSS vs. time across all visits) and annualized TVL derived from consecutive high-resolution T1w MRI (Opfer et al. 2020). Significance tested at p = 0.05. Unit of measure: Pearson correlation coefficient (r), dimensionless (-1 to +1).

Trial sites (2)

FacilityCityRegionStatus
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden Dresden Germany
Multiple Faculties Multiple Locations Germany

Other trials for the same condition

Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study. Recruiting
An Open-label Study of AZD0120 in Adults With Multiple Sclerosis Recruiting
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis Active, not recruiting
MS-DETECT: Early Detection of Multiple Sclerosis Progression With MSCopilot® Detect Active, not recruiting
A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07753928 on ClinicalTrials.gov ↗ ← All trials in Germany