Rituximab's effects 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
This study is testing if the medication rituximab can help improve thinking and hand skills in people with secondary progressive multiple sclerosis who have significant disabilities.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Giza, Giza Governorate) |
| Trial ID | NCT06599307 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with secondary progressive multiple sclerosis with an Expanded Disability Status Scale (EDSS) score of 6.5 or higher.
Not a fit: Patients who have received other disease-modifying therapies for SPMS or have had a clinical relapse in the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve cognitive and hand functions for patients suffering from secondary progressive multiple sclerosis.
How similar studies have performed: While there have been studies on rituximab for other conditions, this specific approach for cognitive and hand function improvement in SPMS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Giza, Giza Governorate
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.