By InvitationNot Applicable

PENTAGON: MS-Related Disability Worsening and Thalamic Volume Loss

Germany2,400 participantsStarted 2022-07-01

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Association between annual change in EDSS and annualized thalamic volume loss (TVL)

Timeframe: months: 0 - 24

Trial details

NCT IDNCT07753928

SponsorJung Diagnostics GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-06-30

View on ClinicalTrials.gov More Multiple Sclerosis, Relapsing-Remitting trials