Goal: To decrease the seizure frequency and severity
Inclusion criteria: Refractory temporal lobe epileptic patients that had not respond to 2 correctly selected anti epileptic drugs
Exclusion criteria: Verapamil usage contraindication
Study population: Refractory temporal lobe epileptic patients
Sample size: 20 patients
Intervention: Verapamil prescription in one group as 120 mg per day and 240 mg per day in the second group
Time-point and primary outcome: In the first 2 months evaluating seizure frequency and type then fallowing 2 months evaluating same things while adding Verapamil tab to medication regime
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012121711778N1
Registration date:2013-03-02, 1391/12/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-02, 1391/12/12
Registrant information
Name
Seyed mohammad ali Razavizadegan Jahromi
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71123054109
Email address
razavima@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2012-11-30, 1391/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of adjunctive use of Verapamil with two doses 120 and 240 mg on control of seizure in patients with refractory temporal lobe epilepsy
Public title
Verapamil effect on refractory epilepsy treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- Male/female patients, aged 18 and above.
- Diagnosis of epilepsy made on the basis of clinical and EEG findings.
- Refractory epilepsy is defined as failure of two or more AEDs at maximal tolerated doses and 2 or more seizures per month.
- There have been no more than 4 weeks between seizures over the 2 months prior to entry to the study.
- Having stable medication regimen for 8 weeks prior to entry.
- Patient is male or a non-pregnant female adequately protected from conception.
- Informed consent by patients or their families/care givers.
Exclusion criteria:
- Patient has a progressive neurological condition.
- Patient has a history of non-compliance for seizure diary completion or frequent clinic visits.
- Patient is pregnant at the time of enrolment.
- Patient has any serious medical illness or major psychiatric disorder, history of psudoseizure, or history of suicidal attempt in the past 5 years.
- Patient has any contraindication for verapamil administration including:
severe GI narrowing, heart failure, hypertrophic cardiomyopathy, cardiac conduction disturbances, hypotension, hepatic impairment, renal impairment, and known history of hypersensitivity to verapamil.
Age
From 18 years old to 53 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Shiraz University of Medical Science
Street address
Central building of Shiraz University of Medical Science, Zand street, Shiraz
City
Shiraz
Postal code
7134814336
Approval date
2012-07-12, 1391/04/22
Ethics committee reference number
CT-P-91-3629
Health conditions studied
1
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
seizure frequency
Timepoint
monthly
Method of measurement
questionnaire and check list
2
Description
seizure quality
Timepoint
monthly
Method of measurement
questionnaire and check list
Secondary outcomes
1
Description
blood pressure
Timepoint
one week after starting Verapamil, one week after titrating Verapamil, and then monthly
Method of measurement
Digital blood pressure monitor
2
Description
pulse rate
Timepoint
one week after starting Verapamil, one week after titrating Verapamil, and then monthly
Method of measurement
counting manually
Intervention groups
1
Description
Adding Verapamil tab as 120 mg daily to previous anti epileptic drugs in patients with refractory temporal lobe epilepsy for 2 months and then comparing the changes in seizure frequency and quality to previous same time.
Category
Treatment - Drugs
2
Description
Adding Verapamil tab as 240 mg daily to previous anti epileptic drugs in patients with refractory temporal lobe epilepsy for 2 months and then comparing the changes in seizure frequency and quality to previous same time.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Clinic, Shiraz University of Medical Science
Full name of responsible person
Dr seyed mohammad ali razavizadegan jahromi
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Deputy director of inquiry of Shiraz University of Medical Science
Street address
Central building of Shiraz University of Medical Science, Zand street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Science
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
Shiraz University of Medical Science
Full name of responsible person
Seyed mohammad ali razavizadegan jahromi
Position
Neurology resident
Other areas of specialty/work
Street address
The forth section, Second floor, Apartment in the end, 9/5, Alley 9, South Safir Street, Shiraz
City
Shiraz
Postal code
7178858618
Phone
+98 71 1835 7279
Fax
Email
alirazavi1357@gmail.com razavima@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Seyed mohammad ali razavizadegan jahromi
Position
Neurology resident
Other areas of specialty/work
Street address
The forth section, Second floor, Apartment in the end, 9/5, Alley 9, South Safir Street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1835 7279
Fax
Email
alirazavi1357@gmail.com razavima@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Seyed mohammad ali razavizadegan jahromi
Position
Neurology resident
Other areas of specialty/work
Street address
The forth section, Second floor, Apartment in the end, 9/5, Alley 9, South Safir Street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1835 7279
Fax
Email
alirazavi1357@gmail.comrazavima@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)