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PENTAGON: MS-Related Disability Worsening and Thalamic Volume Loss

NCT07753928 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 2400

Last updated 2026-08-10

No results posted yet for this 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.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

DRUG

Disease-Modifying Therapies (DMTs)

Disease-Modifying Therapies (DMTs)

Sponsors & Collaborators

  • Jung Diagnostics GmbH

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2027-06-30
Completion
2033-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07753928 on ClinicalTrials.gov