Secondary Progressive Multiple Sclerosis (SPMS)
Conditions
Keywords
Rituximab, Cognitive functions, Hand functions, Secondary Progressive Multiple Sclerosis
Brief 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.
Interventions
DRUGRituximab
Rituximab 1gm vial diluted on 500 ml normal saline 0.9%
OTHERSaline (NaCl 0,9 %) (placebo)
500 ml of normal saline 0.9%
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of rituximab on cognitive functions assessed by The Symbol Digit Modalities Test | 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. |
| The effect of rituximab on cognitive functions assessed by The Brief Visuospatial Memory Test-Revised | 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. |
| The effect of rituximab on cognitive functions assessed by The California Verbal Learning Test-II | 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. |
| The effect of rituximab on hand functions assessed by The Nine-Hole Peg Test | 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
| Measure | Time frame | Description |
|---|---|---|
| The effect of rituximab on quality of life | 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. |
| The effect of rituximab on EDSS | 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. |
Countries
Egypt
Contacts
CONTACTAmgad Mahmoud Elmeligy, MSc Neurology
CONTACTAmr Mohamed Fouad, MD Neurology
STUDY_CHAIRMaha Atef Zaki, MD Neurology
Department of Neurology, Faculty of Medicine, Cairo University
STUDY_CHAIRAmr Hassan Elsayed, MD Neurology
Department of Neurology, Faculty of Medicine, Cairo University
Outcome results
None listed