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MS-Related Disability Worsening and Thalamic Volume Loss

Enrolling By InvitationN/A

Sponsor: Jung Diagnostics GmbH

Conditions: Multiple Sclerosis, Relapsing-Remitting

Interventions: Disease-Modifying Therapies (DMTs)

Countries: Germany

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 overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

General

* MS diagnosed by the revised 2017 McDonald criteria
* Relapsing clinical course and history of brain MRI lesions consistent with MS
* Age 18 to 55 years, inclusive

Active MS group - meet one disease-activity criterion:

* \>10 T2 lesions at the first visit, OR
* ≥1 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
* 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:

* No relapses in the last two years and progressive disease defined clinically (disability worsening) or by imaging (abnormal whole-brain volume loss)
* Participants initially in the active group may switch to the progressive group if they later meet its criteria.

Exclusion Criteria:

* Primary progressive MS (PPMS) or secondary progressive MS (SPMS) at time of enrollment
* Not eligible to receive MRI

Locations (2)

Dresden, Germany
Multiple Locations, Germany