RecruitingRecruiting
The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis
NCT06599307 · Cairo University
In plain English
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Official title
The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis: a Randomized Controlled Trial
About this study
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 criteria
Inclusion Criteria:
1. Diagnosis of secondary progressive multiple sclerosis by Lorscheider et al's criteria (disability progression by 1 EDSS step in patients with EDSS ≤ 5.5 or 0.5 EDSS step in patients with EDSS ≥ 6 in the absence of a relapse, a minimum EDSS score of 4 and pyramidal functional system (FS) score of 2 and confirmed progression over ≥3 months, including confirmation within the leading FS).
2. Baseline EDSS ≥ 6.5.
Exclusion Criteria:
1. Patients received disease modifying therapy for SPMS other than rituximab.
2. Clinical relapse in the last 3 months before recruitment.
3. Patients with documented hypersensitivity or contraindication to rituximab.
4. Patients with concomitant neurologic conditions that may affect cognitive or hand functions.
Study design
Enrollment target: 46 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2024-08-01
Estimated completion: 2026-09
Last updated: 2026-03-18
Interventions
Drug: RituximabOther: Saline (NaCl 0,9 %) (placebo)
Primary outcomes
- • The effect of rituximab on cognitive functions assessed by The Symbol Digit Modalities Test (One year)
- • The effect of rituximab on cognitive functions assessed by The Brief Visuospatial Memory Test-Revised (One year)
- • The effect of rituximab on cognitive functions assessed by The California Verbal Learning Test-II (One year)
Sponsor
Cairo University · other
Contacts & investigators
ContactAmgad Mahmoud Elmeligy, MSc Neurology · contact · amgad.elmeligy92@outlook.com · 00201005393868
ContactAmr Mohamed Fouad, MD Neurology · contact · amro.fouad@yahoo.com · 00201003598364
InvestigatorMaha Atef Zaki, MD Neurology · study_chair, Department of Neurology, Faculty of Medicine, Cairo University
InvestigatorAmr Hassan Elsayed, MD Neurology · study_chair, Department of Neurology, Faculty of Medicine, Cairo University
All locations (1)
Kasr Alainy Multiple Sclerosis Unit (KAMSU), Cairo University hospitals.Recruiting
Giza, Giza Governorate, Egypt