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NCT Number: NCT06599307

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kasr Alainy Multiple Sclerosis Unit (KAMSU), Cairo University hospitals.

Giza, Giza Governorate, Egypt

Location status: Recruiting

Location contact

Amgad Mahmoud Elmeligy, MSc Neurology

PRINCIPAL_INVESTIGATOR

Vice Dean for graduate studies and research

CONTACT

[email protected]

0020223649281

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients received disease modifying therapy for SPMS other than rituximab.
  • Clinical relapse in the last 3 months before recruitment.
  • Patients with documented hypersensitivity or contraindication to rituximab.
  • Patients with concomitant neurologic conditions that may affect cognitive or hand functions.

Treatment and study plan

Rituximab

Drug

Rituximab 1gm vial diluted on 500 ml normal saline 0.9%

Saline (NaCl 0,9 %) (placebo)

Other

500 ml of normal saline 0.9%

Primary outcomes

  1. The effect of rituximab on cognitive functions assessed by The Symbol Digit Modalities Test

    Time frame: One year

    The Symbol Digit Modalities Test (SDMT) presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Patients are asked to identify the digit associated with each symbol as rapidly as possible for 90 seconds. The outcome measure is the number of correct responses over the 90 seconds time span.

  2. The effect of rituximab on cognitive functions assessed by The Brief Visuospatial Memory Test-Revised

    Time frame: One year

    The Brief Visuospatial Memory Test-Revised (BVMT-R) constitutes of six abstract designs presented to the patient for 10 seconds. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. Thus, scores range from 0 to 12. There are three learning trials. The outcome measure is the total number of points earned over the three trials.

  3. The effect of rituximab on cognitive functions assessed by The California Verbal Learning Test-II

    Time frame: One year

    The California Verbal Learning Test-II (CVLT-II) begins with the examiner reading a list of 16 words. Patients listen to the list and report as many of the items as possible. After recall is recorded, the entire list is read again followed by a second attempt at recall. Altogether, there are five learning trials. The outcome measure is the total number of recalled items over the five trials.

  4. The effect of rituximab on hand functions assessed by The Nine-Hole Peg Test

    Time frame: One year

    The Nine-Hole Peg Test (9-HPT) is a wood or plastic board with 9 holes (10 mm diameter, 15 mm depth) and a container. It is administered by asking the patient to take the pegs from a container, one by one, and place them into the holes on the board as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. The outcome measure is the time taken to complete the activity, recorded in seconds.

Secondary outcomes

  1. The effect of rituximab on quality of life

    Time frame: One year

    Using MS-QLQ27 questionnaire, which contains 27 items covering physical, mental, and treatment-specific impairments as well as items relating to leisure, social, and work life issues. Scaling of items is a 5 point scale ranged from 1: "not at all impaired" to 5: "extremely impaired.

  2. The effect of rituximab on EDSS

    Time frame: One year

    The Expanded Disability Status Scale (EDSS) is a tool used for quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.

Study contacts

Contact information is provided by the study sponsor or research team.

Amgad Mahmoud Elmeligy, MSc Neurology

CONTACT

[email protected]

00201005393868

Amr Mohamed Fouad, MD Neurology

CONTACT

[email protected]

00201003598364

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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