The effect of Memantine on cognitive status of epileptic patients
Design
Randomized double blinded two arm parallel group with control group clinical trial
Settings and conduct
Eligible patients will take the FAB, MMSE and MoCA examination and after randomization to 2 groups, participants and doctors will be blinded to the treatment. After taking the patients' history a sealed envelope; contained code A or B; will be given to them, which determine for the pharmacist to give which drug (Memantine and placebo have the same cover) to the patients
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients between 15-65 years old
Epileptic patients with mild to moderate cognitive impairment who received anti-epileptic drugs over 6 months
Seizure episodes less than four times a month
Exclusion criteria:
Progressive neurological disorder, major psychiatric disorder and mental retardation
Severe medical illnesses such as renal failure;
Pregnancy or breastfeeding;
Patients within inter-ictal phase (2 weeks);
Patients with more than 4 seizure episodes over a month;
Adverse drug effect;
Drug allergy or intolerance
Intervention groups
Initiation of 5 mg oral Memantine tablet once a day and continuing the same dose for 8 weeks, after that 10 mg oral Memantine tablet once a day with caution for the rest 8 weeks. So the intervention period was 4 month. In the other group, oral placebo was given once a day for 16 weeks.
Main outcome variables
Prescription of Memantine as a treatment for improving epileptic patients' cognitive status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121110011424N5
Registration date:2019-09-25, 1398/07/03
Registration timing:retrospective
Last update:2019-09-25, 1398/07/03
Update count:0
Registration date
2019-09-25, 1398/07/03
Registrant information
Name
Abbas Tafakhori
Name of organization / entity
Iranian Center of Neurological Research
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 0491
Email address
a_tafakhori@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2018-08-23, 1397/06/01
Actual recruitment end date
2019-02-20, 1397/12/01
Trial completion date
2019-02-20, 1397/12/01
Scientific title
Effects of Memantine on cognitive profile of patients with epilepsy: A randomized, double-blind, placebo-controlled clinical trial
Public title
Effect of Memantine on epileptic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 15-65 years old
Epileptic patients who received anti epileptic drugs over 6 months with mild to moderate cognition impairment
Seizure episodes less than four times a month
Exclusion criteria:
Progressive neurologic disease, psychiatric disorders, and mental retardation
Severe medical illnesses such as renal failure
Pregnancy or breast feeding
Patients during inter-ictal phase (2 weeks)
Patients with seizure episodes more than four times a month
adverse drug effect
drug allergy or intolerance
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into 2 groups with sequentially numbered method( randomization with the random number builder software)
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and doctors are both blinded about the treatment. After taking the patient's history, the researcher give a sealed envelope including code A (Memantine) or code B (placebo) to the patient. Then, patient will give that wrapped envelope to the pharmacist and received the assigned drug (drug A or B which are kept in the same cover from the company). The pharmacist will record patients' name and drug codes without knowing the type of the drug and this information will be kept until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417744361
Approval date
2018-07-24, 1397/05/02
Ethics committee reference number
IR.TUMS.IKHC.REC.1397.052
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures
Primary outcomes
1
Description
Cognitive status score according to MMSE (Folstein mini-mental state examination) criteria
Timepoint
Before intervention and 16 weeks after intervention
Method of measurement
Asking questions of MMSE (Folstein mini-mental state examination )
2
Description
Cognitive status score according to FAB (Frontal Assessment Battery)
Timepoint
Before intervention and 16 weeks after intervention
Method of measurement
Asking questions of FAB (Frontal Assessment Battery)
3
Description
Cognitive status score according to MoCA (Montreal Cognitive Assessment)
Timepoint
Before intervention and 16 weeks after intervention
Method of measurement
Asking questions of MoCA (Montreal Cognitive Assessment)
4
Description
Adverse events
Timepoint
16 weeks after intervention
Method of measurement
Adverse events form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 5 mg Memantine oral tablet once a day for 8 weeks and then 10 mg once a day for another 8 weeks with caution
Category
Treatment - Drugs
2
Description
Control group: placebo once a day for 16 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Abbas Tafakhori
Street address
Neurology clinic of Imam Khomeini hospital, end of Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Fax
+98 21 6658 1604
Email
Imamhospital@tums.ac.ir
Web page address
http://ikhc2.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Tafakhori
Street address
Imam Khomeini Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
a_tafakhori@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Abbas Tafakhori
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Emam Khomeini Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
a_tafakhori@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Tafakhori
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Emam Khomeini Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
a_tafakhori@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pargol Balali
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417744361
Phone
+98 21 8889 6696
Email
p-balali@student.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Title and more details about the data/document
Clinical and demographic data will be available
When the data will become available and for how long
When data was published
To whom data/document is available
Public
Under which criteria data/document could be used
For scientific use only
From where data/document is obtainable
Email (PI)
What processes are involved for a request to access data/document