RecruitingPhase 2NCT06599307

The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis

The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis: a Randomized Controlled Trial

Sponsor

Cairo University

Enrollment

46 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Secondary-progressive Multiple Sclerosis (SPMS)

Summary

The goal of this clinical trial is to know if rituximab can improve cognitive and hand functions in secondary progressive multiple sclerosis (SPMS) patients with high disability (EDSS 6.5 or more). The main questions it aims to answer are: Can rituximab improve cognitive and hand functions in SPMS patients? Can rituximab improve the quality of life and the Expanded Disability Status Scale (EDSS) in SPMS patients? Researchers will compare patients who receive rituximab to patient who receive placebo to see the effects of rituximab on cognition, hand functions, quality of life and EDSS. Demographic and clinical data as age, gender, disease duration and EDSS will be obtained from each participant. Participants will perform The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS), The Nine-Hole Peg Test (9-HPT) and The MS-QLQ27 questionnaire at baseline and after one year of receiving either rituximab or placebo.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether rituximab — a medication that targets certain immune cells — can help improve thinking and hand function in people with secondary progressive multiple sclerosis (SPMS), a form of MS where the disease steadily worsens over time. **You may be eligible if...** - You have been diagnosed with secondary progressive MS and your disability has been steadily worsening (not just during relapses) - Your disability level is at least 6.5 on the EDSS scale (meaning significant walking impairment, typically requiring a walking aid or wheelchair) **You may NOT be eligible if...** - You have received other MS disease-modifying therapies besides rituximab - You had a clinical relapse in the past 3 months - You have a known allergy or contraindication to rituximab - You have another neurological condition that could affect your thinking or hand function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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