(1) Objectives: The comparison of effect of levetiracetam and sodium valproate on seizure attacks frequency of 8-30 year old patients with juvenile myoclonic epilepsy. (2) Design: Single central, Phase 2 trial (3) Setting and conduct: A number of 62 patients (at the age of 8-30 years) with Juvenile myoclonic epilepsy were assigned in to equal groups. The first group was treated with Levetiracetam with the main dosage of 1000 mg daily and the second group was treated with sodium valproate, 800 mg daily. The efficacy of these two drugs was compared with each other by the changes occurred in frequency of seizures during 28 weeks. (4) Participants including major eligibility criteria: 62 patients. Inclusion criteria: Patients with juvenile myoclonic epilepsy; Age between 8 and 30; Absence of brain lesion in MRI; Normal neurologic physical examination. Exclusion criteria: Pregnancy; Secondary epilepsy; Levetiracetam, Lamotrigine or Sodium valproate receiving during last month; Severe organic disease; History of poor compliance(5) Intervention group: Tab Levetiracetam 250 mg orally twice a day for 28 weeks, from Sobhan Pharmaceutical Company. Control group: Tab Sodium valproate 200mg orally twice a day for 28 weeks, from Sobhan Pharmaceutical Company. (6): frequency of seizures
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112715567N1
Registration date:2014-02-15, 1392/11/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-15, 1392/11/26
Registrant information
Name
Fatemeh Sadr
Name of organization / entity
Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3012
Email address
sadr.fa@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2013-04-04, 1392/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effect of levetiracetam and sodium valproate on seizure attacks frequency of 8-30 year old patients with juvenile myoclonic epilepsy
Public title
The comparison of effect of levetiracetam and sodium valproate on seizure attacks frequency of 8-30 year old patients with juvenile myoclonic epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with juvenile myoclonic epilepsy; Age between 8 and 30; Absence of brain lesion in MRI; Normal neurologic physical examination.
Exclusion criteria: Pregnancy; Secondary epilepsy; Levetiracetam, Lamotrigine or Sodium valproate receiving during last month; Severe organic disease; History of poor compliance.
Age
From 8 years old to 30 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
Approval date
2013-12-01, 1392/09/10
Ethics committee reference number
ajums.REC.1392.200
Health conditions studied
1
Description of health condition studied
Generalized idiopathic epilepsy
ICD-10 code
G40.3
ICD-10 code description
Generalized idiopathic epilepsy and epileptic syndromes
Primary outcomes
1
Description
frequency of seizures
Timepoint
monthly
Method of measurement
according to history
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Tab Levetiracetam500 mg orally twice a day for 28 weeks, from Sobhan Pharmaceutical Company
Category
Treatment - Drugs
2
Description
Control group: Tab Sodium valproate 400 mg orally twice a day for 28 weeks, from Sobhan Pharmaceutical Company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Fatemeh Sadr
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mostafa Feghhi, MD
Street address
Esfand St, Golestan Blv.
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 for research, Ahvaz Jundishapur 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
Jundishapur University of Medical Sciences
Full name of responsible person
Fatemeh Sadr
Position
Assistant of Neurology
Other areas of specialty/work
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 1374 3012
Fax
Email
f.sadr61@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jundishapur University of Medical Sciences
Full name of responsible person
Davud Kashipazha, MD
Position
Professor Assistant
Other areas of specialty/work
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 1374 3012
Fax
Email
dakaski47@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jundishapur University of Medical Sciences
Full name of responsible person
Fatemeh Sadr
Position
Assistant of Neurology
Other areas of specialty/work
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 1374 3012
Fax
Email
f.sadr61@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)