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

Rituximab Trial for Secondary Progressive MS: Improving Cognition and Hand Function

NCT: NCT06599307 · Status: RECRUITING · Phase: Phase 2 · Sponsor: Cairo University · Started: 2024-08-01 · Est. Completion: 2026-09

Plain English Summary

The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis is a Phase 2 clinical trial sponsored by Cairo University studying Secondary Progressive Multiple Sclerosis (SPMS). This trial tests if the drug rituximab can improve thinking abilities and hand dexterity in people with a specific type of multiple sclerosis. It is for adults diagnosed with secondary progressive multiple sclerosis (SPMS) who have significant disability. Participants will receive either rituximab or a placebo (a dummy treatment) for one year, with regular assessments of their cognitive and hand functions. Alternative treatments for SPMS may include other disease-modifying therapies, symptom management, and rehabilitation. The trial aims to enroll 46 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You may be able to join if you have been diagnosed with secondary progressive multiple sclerosis and have a certain level of disability (EDSS score of 6.5 or higher). You cannot join if you have recently had a relapse, have a known allergy to rituximab, or have other neurological conditions that could affect thinking or hand use. You also cannot join if you are currently taking a different medication for SPMS, unless it is rituximab. The trial is for adults, and specific age ranges are not detailed in the summary, but the focus is on patients with advanced disability. This trial is studying Secondary Progressive Multiple Sclerosis (SPMS), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure whether rituximab can lead to better performance on tests of thinking skills and how well you can use your hands after one year of treatment. The specific primary outcome measures are: The effect of rituximab on cognitive functions assessed by The Symbol Digit Modalities Test (One year); The effect of rituximab on cognitive functions assessed by The Brief Visuospatial Memory Test-Revised (One year); The effect of rituximab on cognitive functions assessed by The California Verbal Learning Test-II (One year); The effect of rituximab on hand functions assessed by The Nine-Hole Peg Test (One year). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a critical need for treatments that can improve cognitive and motor functions in patients with advanced secondary progressive multiple sclerosis, a condition with limited effectiv Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Secondary Progressive Multiple Sclerosis (SPMS), where improved treatment options are needed.

Investor Insight

This Phase 2 trial for a known drug (rituximab) in a specific MS subtype suggests a focused approach to improving quality of life for a patient population with unmet needs, potentially indicating a ma Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if rituximab is a suitable option for you and what the potential benefits and risks are. Participation involves receiving either rituximab or a placebo for a year, with regular visits for tests measuring thinking, hand function, and quality of life. You will need to undergo assessments like cognitive tests (e.g., Symbol Digit Modalities Test) and hand function tests (e.g., Nine-Hole Peg Test) at the start and after one year. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full 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.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06599307?

NCT06599307 is a Phase 2 INTERVENTIONAL study titled "The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis." It is currently recruiting and is sponsored by Cairo University. The trial targets enrollment of 46 participants.

What conditions does NCT06599307 study?

This trial investigates treatments for Secondary Progressive Multiple Sclerosis (SPMS). The primary condition under study is Secondary Progressive Multiple Sclerosis (SPMS).

What treatments are being tested in NCT06599307?

The interventions being studied include: Rituximab (DRUG), Saline (NaCl 0,9 %) (placebo) (OTHER). Rituximab 1gm vial diluted on 500 ml normal saline 0.9%

What does Phase 2 mean for NCT06599307?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT06599307?

This trial is currently "Recruiting." It started on 2024-08-01. The estimated completion date is 2026-09.

Who is sponsoring NCT06599307?

NCT06599307 is sponsored by Cairo University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06599307?

The trial aims to enroll 46 participants. The trial is currently recruiting and accepting new participants.

How is NCT06599307 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT06599307?

The primary outcome measures are: The effect of rituximab on cognitive functions assessed by The Symbol Digit Modalities Test (One year); The effect of rituximab on cognitive functions assessed by The Brief Visuospatial Memory Test-Revised (One year); The effect of rituximab on cognitive functions assessed by The California Verbal Learning Test-II (One year); The effect of rituximab on hand functions assessed by The Nine-Hole Peg Test (One year). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06599307 being conducted?

This trial is being conducted at 1 site, including Giza, Giza Governorate (Egypt).

Where can I find official information about NCT06599307?

The official record for NCT06599307 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06599307. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06599307 testing in simple terms?

This trial tests if the drug rituximab can improve thinking abilities and hand dexterity in people with a specific type of multiple sclerosis. It is for adults diagnosed with secondary progressive multiple sclerosis (SPMS) who have significant disability.

Why is this trial significant?

This trial addresses a critical need for treatments that can improve cognitive and motor functions in patients with advanced secondary progressive multiple sclerosis, a condition with limited effectiv

What are the potential risks of participating in NCT06599307?

The most common risks associated with rituximab include infusion-related reactions (like fever or chills) and an increased risk of infections. Specific side effects can include low blood cell counts, skin reactions, and, rarely, more serious reactions like a severe lung infection. There is also a risk that the treatment may not be effective in improving your cognitive or hand functions. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06599307?

Ask your doctor if rituximab is a suitable option for you and what the potential benefits and risks are. Participation involves receiving either rituximab or a placebo for a year, with regular visits for tests measuring thinking, hand function, and quality of life. You will need to undergo assessments like cognitive tests (e.g., Symbol Digit Modalities Test) and hand function tests (e.g., Nine-Hole Peg Test) at the start and after one year. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06599307 signal from an investment perspective?

This Phase 2 trial for a known drug (rituximab) in a specific MS subtype suggests a focused approach to improving quality of life for a patient population with unmet needs, potentially indicating a ma This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participants will receive either rituximab or a placebo (a dummy treatment) for one year, with regular assessments of their cognitive and hand functions. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

More Secondary Progressive Multiple Sclerosis (SPMS) Trials

View all Secondary Progressive Multiple Sclerosis (SPMS) clinical trials

This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.