The main objective of this study is to evaluate the tolerability and safety of Zonisamide as an adjunctive therapy in all kinds of Seizures that are resistant to routine treatment. The inclusion and exclusion criteria of this study are as following: Inclusion criteria: 1) Seizure frequency ≥4 per month in spite of treatment with 2 AED ( Intractable Seizure) 2) Age above 17 3) Any type of Seizure Disorders Exclusion Criteria: 1) Having progressive encephalopathy or any structural disorders of central nervous system now or before taking part in this study 2) Having any diseases in other organ systems such as eyes, heart, blood, kidney, liver now or before taking part in this study 3) sulfunamide sensitivity 4) Married women in reproductive age 5) Using Acetazolamide as an AED 6) Not having any cooperation in using drug 7) Any severe side effects of drug 8) Not having consensus about continuation of the study Total number of patients are about 56. Zonisamide will be started in 50 mg twice a day then after 1 week clinical condition and side effect will be evaluated then 100 mg twice a day will be started up to 400 mg in 1st month based on clinical situation,then if necessary increasing dosage may be included.In these process number of seizures and side effects will be evaluated.All patients will be assessed by phone follow up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811153278N1
Registration date:2009-11-01, 1388/08/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-11-01, 1388/08/10
Registrant information
Name
Sepehr Haghighi
Name of organization / entity
Isfahan Medical University
Country
Iran (Islamic Republic of)
Phone
+98 31 1261 5182
Email address
s_haghighi@edc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan Medical College- Bakhtar Bioshimi Company in Kermanshah
Expected recruitment start date
2009-11-01, 1388/08/10
Expected recruitment end date
2010-06-01, 1389/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Study of efficacy and tolerability of adjunctive therapy with Zonisamide in adulthood intractable epilepsy
Public title
The Study of efficacy and tolerability of adjunctive therapy with Zonisamide in adulthood intractable epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Sizure Frequency ≥4per month inspite of treatment with 2 AED( Intractable Seizure)
2) Age above 17
3) Any types of Seizure Disorders
Exclusion Critera:
1) Having progressive encephalopathy or any structral disorders of central nervous system now or before takeing part into this study
2) Having any diseases such as eyes, heart, blood, kidney, liver now or before taking part into this study
3) sulfunamide sensitivity
4) Married women in pregnancy ages
5) Using Acetazolamide as an AED
6) Not having any cooperation in using drug
7) Any severe side effects of drug
8) Not having consensus abot continuation of the study
Age
From 17 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences and Health Services
Street address
Hezar Jarib St-Isfahan
City
Isfahan
Postal code
Approval date
empty
Ethics committee reference number
289047
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40
ICD-10 code description
Episodic and paroxysmal disorders
Primary outcomes
1
Description
Seizure frequency
Timepoint
1 week, 2 week, 3 week, 1 month, 2 month, 3 month
Method of measurement
assesment of seizure frequency with asking from patients and filling questionnaire
Assesment of side effect by asking patients and filling a questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Treatment with Zonisamide, Capsule 50, 100mg, oral, for 3 months.follow up every week for increasing doses based on clinics and side effects-Max dose is 600 mg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Azahra Hospital in Isfahan
Full name of responsible person
Street address
Alzahra Hospital, Sefeh st.,
City
Isfahan
2
Recruitment center
Name of recruitment center
Kashani Hospital in Isfahan
Full name of responsible person
Street address
Kashani st.,
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University Of Medical Sciences and Health Services
Full name of responsible person
Dr Mohammad Reza Najafi
Street address
Azahra Hospital, Soffeh st.,
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University Of Medical Sciences and Health Services
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
Isfahan Medical University
Full name of responsible person
Dr Mohammad Reza Najafi
Position
Associate Professor
Other areas of specialty/work
Street address
Number3, Behnaz close, Bagh beh Alley, Tohid st.,
City
Isfahan
Postal code
Phone
+98 31 1261 5182
Fax
Email
najafi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Medical University
Full name of responsible person
Dr Mohammad Reza Najafi
Position
Associate Professor
Other areas of specialty/work
Street address
Number3, Behnaz close, Bagh beh Alley, Tohid st.,
City
Isfahan
Postal code
Phone
+98 31 1261 5182
Fax
Email
najafi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)