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

Launched by CAIRO UNIVERSITY · Sep 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called rituximab can help improve thinking skills and hand functions in people with secondary progressive multiple sclerosis (SPMS) who have significant disabilities. The researchers want to find out if rituximab can also enhance overall quality of life for these patients. To do this, they will compare two groups of participants: one group will receive rituximab, while the other will receive a placebo (a treatment that looks the same but has no active ingredients). Over the course of a year, participants will complete tests to measure their cognitive abilities, hand function, and quality of life.

To be eligible for this trial, participants need to have a confirmed diagnosis of SPMS and a disability score of 6.5 or higher on the Expanded Disability Status Scale (EDSS), which measures how much the disease affects their daily life. They should not have received other treatments for SPMS in the last three months or have other medical conditions that could impact their cognitive or hand functions. Participants will also provide information about their age, gender, and how long they have had the disease. This trial is currently recruiting participants aged 65 to 74. If you or someone you know fits this description and is interested in contributing to this important research, it could be a great opportunity to help advance our understanding of SPMS treatments.

Gender

ALL

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.