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A controlled phase II clinical trial evaluating the safety and efficacy of myelin peptide-loaded tolDC as treatment for Multiple Sclerosis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512891-37-00
Enrollment
48
Registered
2024-11-22
Start date
Unknown
Completion date
2025-11-06
Last updated
2024-11-25

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

Conditions

Multiple Sclerosis

Brief summary

Efficacy will be determined by evaluating the number of new and enlarging T2 lesions on MRI scans

Detailed description

The number and severity of adverse events, Proportion of relapse-free patients, Changes in relapse rate (compared with the year before inclusions), Changes from baseline in mean EDDS scores and supplementary ambulatory clinical outcome measures, change from baseline in T1 Gd and T2 lesion load, atrophy, and total brain volume on MRI scans

Interventions

DRUGtolDC

Sponsors

Antwerp University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Secondary

MeasureTime frame
The number and severity of adverse events, Proportion of relapse-free patients, Changes in relapse rate (compared with the year before inclusions), Changes from baseline in mean EDDS scores and supplementary ambulatory clinical outcome measures, change from baseline in T1 Gd and T2 lesion load, atrophy, and total brain volume on MRI scans

Primary

MeasureTime frame
Efficacy will be determined by evaluating the number of new and enlarging T2 lesions on MRI scans

Countries

Belgium, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026