NCT06599307RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 10 Sept 2024
- Start date
- 1 Aug 2024
- Primary completion date
- Sept 2026
- Lead sponsor
- Cairo University
- Diseases
- Multiple sclerosis
- NCT number
- NCT06599307
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 46
- From 1 Aug 2024 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients received disease modifying therapy for SPMS other than rituximab.
- Clinical relapse in the last 3 months before recruitment.
- Patients with concomitant neurologic conditions that may affect cognitive or hand functions.
Other illness
- Patients with documented hypersensitivity or contraindication to rituximab.
Who the study is looking for
- 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).
- Baseline EDSS ≥ 6.5.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kasr Alainy Multiple Sclerosis Unit (KAMSU), Cairo University hospitals. Coordinator of this site? Confirm its status | Giza | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.