Choosing the right drug with the least side effects and highest effectiveness for the control of epilepsy in the elderly population is important. This study compared the lamotrigine efficacy with levetiracetam in the management of epilepsy in the elderly. The patients with age more than 60y and one year history of epilepsy were enrolled in this study. The study was double-blind randomized clinical trial. Patients were divided randomly into two groups. Group I and Group II treated with treated with lamotrigine were Lvtyrastam. The follow up of patients were done in 2, 4, 8, 12 and 20 week after completion of treatment to assessment of number of epilepsy attack, abnormality of lab test and drug complication. The patients were exclude due to lack of follow-up, severe medical complications and death.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013021211560N3
Registration date:2013-05-18, 1392/02/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-18, 1392/02/28
Registrant information
Name
Tayeb Ramim
Name of organization / entity
Sina Trauma and Surgery Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 0000
Email address
tayebramim@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Tehran University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing efficacy and tolerability of lamotrigine and levetiracetam in elderly patient with diagnosed epilespy
Public title
Epilepsy management in elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : age>60 years old; one year diagnosis; two or more attack in the last year; one and more attack in 6 months ago; life expectancy more one year; unprovoked or generalized epilepsy; no history of lamotrigine and levetiracetam sensitivity and no history of mental disorder.
Exclusion criteria: no tolerability to drug reaction; severe complication; lost to follow up; drug and alcohol abuse; low level of consciousness after drug use due to underlying disease and death.
Age
From 65 years old to 100 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
95
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Hemat gateway, Central devision of Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
827
Health conditions studied
1
Description of health condition studied
Elderly epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy
Primary outcomes
1
Description
Epilepsy management
Timepoint
Four weeks after drug use
Method of measurement
Interview
Secondary outcomes
empty
Intervention groups
1
Description
Lamotrigine was start in 25mg/day and continue to 200mg/day
Category
Treatment - Drugs
2
Description
Levetiracetam was start in 250mg/day and continue to 1000mg/day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Pardis Etemadi
Street address
Sina Hospital, Imam Khomeini St, Hasan Abad Sq
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research,Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research,Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Sina Hospital, Tehran University of Medical Sciences
Full name of responsible person
Pardis Etemadi
Position
MD, Neurology assistant
Other areas of specialty/work
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
Email
pardisedemadi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sina Hospital, Tehran University of Medical Sciences
Full name of responsible person
Pardis Etemadi
Position
MD, Neurology assistant
Other areas of specialty/work
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Postal code
Phone
+98 21 6312 0000
Fax
Email
pardisedemadi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sina Hospital, Tehran University of Medical Sciences
Full name of responsible person
Pardis Etemadi
Position
MD, Neurology assistant
Other areas of specialty/work
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Postal code
Phone
+98 21 6312 0000
Fax
Email
pardisedemadi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)