NCT06599307 The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis
| NCT ID | NCT06599307 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cairo University |
| Condition | Secondary Progressive Multiple Sclerosis (SPMS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 46 participants in total. It began in 2024-08-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Maha Atef Zaki, MD Neurology
STUDY CHAIR
Department of Neurology, Faculty of Medicine, Cairo University
Frequently Asked Questions
Who can join the NCT06599307 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Secondary Progressive Multiple Sclerosis (SPMS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06599307 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06599307 currently recruiting?
Yes, NCT06599307 is actively recruiting participants. Contact the research team at amgad.elmeligy92@outlook.com for enrollment information.
Where is the NCT06599307 trial being conducted?
This trial is being conducted at Giza, Egypt.
Who is sponsoring the NCT06599307 clinical trial?
NCT06599307 is sponsored by Cairo University. The principal investigator is Maha Atef Zaki, MD Neurology at Department of Neurology, Faculty of Medicine, Cairo University. The trial plans to enroll 46 participants.
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