Rituximab's effects on cognitive and hand functions in secondary progressive multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates whether rituximab can enhance cognitive and hand functions in patients with secondary progressive multiple sclerosis (SPMS) who have significant disability. Participants will be randomly assigned to receive either rituximab or a placebo, and their cognitive abilities, hand functions, quality of life, and disability status will be assessed over a year using standardized tests. The study aims to determine if rituximab can lead to measurable improvements in these areas compared to the placebo group.

Why it matters

Who can join: the full rules

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.

Where it's running

• Kasr Alainy Multiple Sclerosis Unit (KAMSU), Cairo University hospitals.
  Giza, Giza Governorate, Egypt Recruiting

Study contacts

• Study coordinator: Amgad Mahmoud Elmeligy, MSc Neurology
• Email: amgad.elmeligy92@outlook.com
• Phone: 00201005393868

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.