Evaluation of the effect of Levetiracetam on cognitive impairment in patients with relapsing- remitting multiple sclerosis (RRMS) based on minimal assessment of cognitive function in multiple sclerosis (MACFIMS)
Evaluation of the effect of Levetiracetam on cognitive impairment in patients with relapsing-remitting multiple sclerosis based on minimal assessment of cognitive function in multiple sclerosis
Design
Clinical trial with control group,with parallel groups,double-blind,randomized, phase 3 on 88 patients.For randomization by random block method
Settings and conduct
A double-blind clinical trial will be conducted at Sina Hospital MS Research Center.88 patients with relapsing-remitting MS were randomly divided into case and control groups and treated with levetiracetam or placebo for 16 weeks.The starting dose is 250 mg twice daily and the dose is Reaches 1000 mg twice a day.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with relapsing- remitting MS 18-60 years؛Minimum education for cognitive tests؛At least 2 years have passed since the disease - Receiving oral and injectable disease-modifying drugs(DMD)؛Expanded Disability Status Scale less 5.5
Exclusion criteria: The type and dose of (DMD) have changed in the last six months؛Corticosteroids received in the last thirty days؛Attack in the last sixty days.
Intervention groups
Intervention group: 44 patients with relapsing-remitting MS(RRMS) are treated with levetiracetam for 16 weeks.The starting dose is 250 mg twice daily and 500 mg is added to the daily dose every week and the drug dose is 1000 mg twice daily.Control group: 44 (RRMS) patients are treated with placebo for 16 weeks.
Main outcome variables
Main Outcome:minimal assessment of cognitive function in multiple sclerosis (MACFIMS) ,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210707051810N2
Registration date:2021-10-05, 1400/07/13
Registration timing:registered_while_recruiting
Last update:2021-10-05, 1400/07/13
Update count:0
Registration date
2021-10-05, 1400/07/13
Registrant information
Name
Maryam Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8601 7570
Email address
maryamsharif.424@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Levetiracetam on cognitive impairment in patients with relapsing- remitting multiple sclerosis (RRMS) based on minimal assessment of cognitive function in multiple sclerosis (MACFIMS)
Public title
Evaluation of the effect of Levetiracetam on cognitive impairment in patients with MS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with relapsing-remitting multiplesclerosis age between 18 and 60 years
Have a minimum education to perform cognitive tests
RRMS (2017 Revisions of the “McDonald” Criteria )
At least 2 years have passed since the definitive diagnosis of the disease
Receiving first-line injectable and oral disease modifying drugs (interferon beta, glatiramer acetate, triflunomide and dimethyl fumarate)
Type and dose of DMD have not changed in the last six months
Have not received corticosteroids in last 30 days
Have not relapse in the last 60 days
Expanded Disability Status Scale (EDSS) scores of 5.5 or less
Voluntarily participated in the present study
Exclusion criteria:
History of drug or alcohol abuse in the last six months
Pregnancy and lactation
Having any acute or major mental disorder that is not under control (type of medication and amount of use in the last three months is constant)
Having any seizure disorder
History of any suicide attempt
Chronic kidney disease (Estimated glomerular filtration rate less than 60 ml / min)
Diabetes, hypothyroidism and anemia that is not under control
Concomitant use of drugs that may affect cognitive function, such as antipsychotics, modafinil, methylphenidate, amphetamine and amphetamine-like compounds, tricyclic antidepressants and anticonvulsants other than gabapentin and pregabalin, benzodiazepines other than as sleeping pills Avar (if the dose and method of medication do not change in the last three months and during the study will not be prohibited).
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with relapsing-remitting MS will be divided into two groups by quadruple block randomization. Random sequencing is performed by an epidemiologist using the online program at https://www.sealedenvelope.com/ Hiding is also guaranteed using the block randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is a double-blind study and for this purpose, the participants, the main researcher, the health care personnel who are responsible for caring for the patient, do not know which participant received the main drug and which placebo. The end of the evaluation of the results between the two groups will be statistically analyzed.The main researcher is aware of the drug and the placebo of the cans, but remains blind as to which patient receives which drug code.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran, Enghelab Square, 16 Azar St., University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2021-08-02, 1400/05/11
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.515
Health conditions studied
1
Description of health condition studied
Relapsing-remitting multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Minimal Assessment of Cognitive Function In Multiple Sclerosis (MACFIMS)
Timepoint
Beginning of study and end of week 16
Method of measurement
MACFIMS questionnaire
2
Description
California Verbal Learning Test (CVLT)
Timepoint
Beginning of study and end of week 16
Method of measurement
California Verbal Learning Test (CVLT)
3
Description
Brief Visuospatial Memory Test Revised (BVMT)
Timepoint
Beginning of study and end of week 16
Method of measurement
Brief Visuospatial Memory Test Revised (BVMT)
4
Description
Paced Auditory Seaial Addition Test(PASAT)
Timepoint
Beginning of study and end of week 16
Method of measurement
Paced Auditory Seaial Addition Test(PASAT)
5
Description
Symbol Digit Modalitis Testing(SDMT)
Timepoint
Beginning of study and end of week 16
Method of measurement
Symbol Digit Modalitis Testing(SDMT)
6
Description
Delis-Kaplan Executive Function System(D-KEFS)
Timepoint
Beginning of study and end of week 16
Method of measurement
Delis-Kaplan Executive Function System(D-KEFS)
7
Description
Controlled Oral Word Association Test(COWAT)
Timepoint
Beginning of study and end of week 16
Method of measurement
Controlled Oral Word Association Test(VCOWAT)
8
Description
Judgment of Line Orientation(JLO)
Timepoint
Beginning of study and end of week 16
Method of measurement
Judgment of Line Orientation(JLO)
Secondary outcomes
1
Description
Neuropsychiatry Complications of levetiracetam
Timepoint
The end of the fourth and sixteenth week
Method of measurement
Neuropsychiatry Inventory (NPI)
2
Description
Possible side effects of Levetiracetam
Timepoint
Every two weeks until the end of 16 weeks
Method of measurement
Case report form (CRF)
3
Description
White blood cells from blood cells and part of the immune system
Timepoint
Beginning of study and end of week 16
Method of measurement
Blood test
4
Description
Hemoglobin
Timepoint
Beginning of study and end of week 16
Method of measurement
Blood test
5
Description
Platelet
Timepoint
Beginning of study and end of week 16
Method of measurement
Blood test
6
Description
Alanine amino trans ferase ( ALT)
Timepoint
Beginning of study and end of week 16
Method of measurement
Blood test
7
Description
Aspartate amino transferase
Timepoint
Beginning of study and end of week 16
Method of measurement
Blood test
8
Description
Cratinine
Timepoint
Beginning of study and end of week 16
Method of measurement
Blood test
9
Description
Blood urea nitrogen (BUN)
Timepoint
Beginning of study and end of week 16
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: Patients in the case group are treated with Levetiracetam for 16 weeks from a reputable Abidi Pharmaceutical Factory. The initial dose is 250 mg (half a tablet) twice a day. 500 mg is added to the daily dose every week, and finally the dose of the drug reaches 1000 mg twice a day.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group are treated for 16 weeks with a placebo of Levetiracetam prepared by a Abidi Pharmaceutical Factory (Matching placebo). The initial dose of placebo is 250 mg (half a tablet) twice a day. 500 mg is added to the daily dose every week, and finally the dose of the drug reaches 1000 mg twice a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital MS Research Center
Full name of responsible person
Hooshyar Honarmand
Street address
Sina Hospital, Imam Khomeini St, Hasan Abad Sq
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 0216 3120
Fax
+98 21 6634 8587
Email
hosp_sina@sina.tums.ac.ir
Web page address
http://sinahospital.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hooshyar Honarmand
Street address
Valiasr Square, Keshavarz Boulevard, 16 Azar St., Poursina St.
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hooshyar Honarmand
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pharmacotherapy
Street address
Sina Hospital, Imam Khomeini St, Hasan Abad Sq
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 8832 2025
Email
Hooshyar1978@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hooshyar Honarmand
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Pharmacotherapy
Street address
Sina Hospital, Imam Khomeini St, Hasan Abad Sq
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 8832 2025
Email
Hooshyar1978@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hooshyar Honarmand
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Pharmacotherapy
Street address
Sina Hospital, Imam Khomeini St, Hasan Abad Sq
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 8832 2025
Email
Hooshyar1978@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
According to the items mentioned in the informed consent, patients' information will not be disseminated.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Patient demographic data as well as variable outcome data will be shared after patients are unidentifiable.
When the data will become available and for how long
The data will be available after the study and is expected to be available on the Internet from March 2022.
To whom data/document is available
Medical activists
Under which criteria data/document could be used
The data will be available after obtaining the necessary permits from researchers.
From where data/document is obtainable
Tehran university of medical science
What processes are involved for a request to access data/document
A written request for data must be submitted by the individual.