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

NCT06599307 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

  • Secondary Progressive Multiple Sclerosis (SPMS)

Interventions

DRUG

Rituximab

Rituximab 1gm vial diluted on 500 ml normal saline 0.9%

OTHER

Saline (NaCl 0,9 %) (placebo)

500 ml of normal saline 0.9%

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Maha Atef Zaki, MD Neurology · Department of Neurology, Faculty of Medicine, Cairo University

  • Amr Hassan Elsayed, MD Neurology · Department of Neurology, Faculty of Medicine, Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

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 NCT06599307 on ClinicalTrials.gov