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IRCT2012121711778N1 IRCT 2013-03-02 Shiraz University of Medical Science Verapamil effect on refractory epilepsy treatment Efficacy of adjunctive use of Verapamil with two doses 120 and 240 mg on control of seizure in patients with refractory temporal lobe epilepsy 2012-11-21 anticipated 20 Complete https://irct.ir/trial/11989 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A epilepsy. Intervention 1: 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. Intervention 2: 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.
public Seyed mohammad ali razavizadegan jahromi
The forth section, Second floor, Apartment in the end, 9/5, Alley 9, South Safir Street, Shiraz
Shiraz Iran (Islamic Republic of) 7178858618 +98 71 1835 7279 alirazavi1357@gmail.com razavima@sums.ac.ir Shiraz University of Medical Science scientific Seyed mohammad ali razavizadegan jahromi
The forth section, Second floor, Apartment in the end, 9/5, Alley 9, South Safir Street, Shiraz
Shiraz Iran (Islamic Republic of) +98 71 1835 7279 alirazavi1357@gmail.com razavima@sums.ac.ir Shiraz University of Medical Science Iran (Islamic Republic of) 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. 18 years 53 years Both G40.2 Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures Treatment - Drugs Treatment - Drugs 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. 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. Seizure frequency. Timepoint: monthly. Method of measurement: questionnaire and check list. Seizure quality. Timepoint: monthly. Method of measurement: questionnaire and check list. Blood pressure. Timepoint: one week after starting Verapamil, one week after titrating Verapamil, and then monthly. Method of measurement: Digital blood pressure monitor. Pulse rate. Timepoint: one week after starting Verapamil, one week after titrating Verapamil, and then monthly. Method of measurement: counting manually. Shiraz University of Medical Science Approved 2012-07-12 Shiraz University of Medical Science Central building of Shiraz University of Medical Science, Zand street, Shiraz Shiraz Iran (Islamic Republic of)