Objective: In this study has been compared the efficacy and tolerability of Phenytoin versus Oxcarbazepine in the newly diagnosed elderly patients with secondary generalized epilepsy.
Methods: We enrolled in this study 142 elderly patients with epilepsy that refered to Neurology clinic of Ahvaz Golestan Hospital after considering the measures of exclusion and inclusion criteria. (Inclusion criteria:Age greater than 65 years old; Not having acute treatable cause; Having secondary generalized epilepsy according to history And Exclusion criteria: Previous history of reaction to phenytoin or Oxcarbazepine; Having other causes except cerebrovascular disease as primary cause of epilepsy). Then the patients were devided in two groups randomly. For one group were administered phenytoin capsule(greater than 70 years old, 100mg, twice daily & lesser than70 years old, 100mg, three times daily) And the other group, oxcarbazepine tablet 300mg, twice daily in a double blind manner for 6 months.In this period patients were followed up for sideeffects and their response to treatment (not having seizure).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202068943N1
Registration date:2012-03-17, 1390/12/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-17, 1390/12/27
Registrant information
Name
Mehran Keshavarzi
Name of organization / entity
Golestan Hospital
Country
Iran (Islamic Republic of)
Phone
+98 61 1320 9577
Email address
keshavarzi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor in research of Ahvaz Jundishapur University
Expected recruitment start date
2010-11-26, 1389/09/05
Expected recruitment end date
2011-06-10, 1390/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and side-effects of Phenytoin versus Oxcarbazepine in secondary generalized epilepsy in the elderly
Public title
efficacy of Oxcarbazepine and Phenytoin in control of epilepsy in the elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age greater than 65 y/o; Not having acute treatable cause; Having secondary generalized epilepsy according to history and
Exclusion criteria: Previous history of reaction to phenytin or Oxcarbazepine; Having other causes except cerebrovascular disease as primary cause of epilepsy.
Age
From 65 years old to 87 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
142
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University
Street address
Medical Science Faculty
City
Ahvaz
Postal code
61335
Approval date
2010-06-12, 1389/03/22
Ethics committee reference number
245/د
Health conditions studied
1
Description of health condition studied
epilepsy
ICD-10 code
G40.1
ICD-10 code description
Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures
2
Description of health condition studied
epilepsy
ICD-10 code
G40.2
ICD-10 code description
Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures
Primary outcomes
1
Description
Dizziness
Timepoint
at onset,after 2 weeks,1 month, 2 months,4 months and 6 months
Method of measurement
History and physical examination
2
Description
Nausea and vomiting
Timepoint
at onset,after 2 weeks,1 month, 2 months,4 months and 6 months
Method of measurement
History and physical examination
3
Description
Ataxia
Timepoint
at onset,after 2 weeks,1 month, 2 months,4 months and 6 months
Method of measurement
History and physical examination
4
Description
Somnolence
Timepoint
at onset,after 2 weeks,1 month, 2 months,4 months and 6 months
Method of measurement
History and physical examination
5
Description
Lethargy
Timepoint
at onset,after 2 weeks,1 month, 2 months,4 months and 6 months.
Method of measurement
History and physical examination
6
Description
Skin reaction
Timepoint
at onset,after 2 weeks,1 month, 2 months,4 months and 6 months.
Method of measurement
History and physical examination
7
Description
gingival hyperplasia
Timepoint
at onset,after 2 weeks,1 month, 2 months,4 months and 6 months.
Method of measurement
History and physical examination
8
Description
Seizure symptoms
Timepoint
at onset,after 2 weeks,1 month, 2 months,4 months and 6 months.
Method of measurement
History and physical examination
Secondary outcomes
empty
Intervention groups
1
Description
For the group A were administered phenytoin capsule 100mg ( >70 y/o 100mg BID & <70 y/o 100mg TDS) and placebo tablet 150mg started 150mg,BID and increased to 300mg BID during 2 weeks.the course of treatment was 6months.
Category
Treatment - Drugs
2
Description
the group B oxcarbazepine 150mg (300mg, BID) was administered.that started with 150 mg BID and increased to 300mg BID during 2weeks. also placebo capsule 100mg(>70 y/o,BID &<70y/o, TDS) was administered.the course of treatment was 6months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Special Clinic of Neurology of Golestan Hospital
Full name of responsible person
Mehran Keshavarzi MD, Resident of Neurology
Street address
Department of Neurology(Golestan Hospital)
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor in Reaserch of Jondishapur University
Full name of responsible person
Khosravi Azardokht MD
Street address
Medical Science Facaulty
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor in Reaserch of Jondishapur University
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
Medical Science Facaulty
Full name of responsible person
Mehran Keshavarzi
Position
Neurology Resident
Other areas of specialty/work
Street address
Ahvaz Jundishapur University
City
Ahvaz
Postal code
Phone
+98 61 1373 8302
Fax
Email
Keshavarzi.m@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical Science Facaulty
Full name of responsible person
Mehran Keshavarzi
Position
Neurology Resident
Other areas of specialty/work
Street address
Jondishapur University
City
Ahvaz
Postal code
61335
Phone
+98 61 1373 8302
Fax
+98 61 1333 2036
Email
Keshavarzi.m@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical Science Facaulty
Full name of responsible person
Mehran Keshavarzi
Position
Neurology Resident
Other areas of specialty/work
Street address
Jundishapur University
City
Ahvaz
Postal code
61335
Phone
+98 61 1373 8302
Fax
+98 33 32036
Email
keshavarzi.m@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)