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

Sponsor
Cairo University
Study ID
NCT06599307
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Secondary Progressive Multiple Sclerosis (SPMS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab 1gm vial diluted on 500 ml normal saline 0.9%
  • Saline (NaCl 0,9 %) (placebo) — OTHER
    500 ml of normal saline 0.9%

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention
    This group will receive Rituximab as follows: initial 1gm divided into 2 doses (500 mg each) given 2 weeks apart then another 1gm will be given after 6 months. Vials will be diluted on 500 ml normal saline 0.9% and will be given as intravenous infusions.
  • Placebo Comparator: Control
    This group will receive 500 ml normal saline 0.9% as intravenous infusions. Another dose will be given after 6 months

Primary Outcome Measure

The effect of rituximab on cognitive functions assessed by The Symbol Digit Modalities Test [ Time Frame: One year ]

Central Contacts

Related Studies