NCT06599307

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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%

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-09-19
• Last updated: 2026-03-18

Locations

1 site across 1 country: Egypt