The purpose of this study is to determine weather Remegal in fixed dosage 1500 mg/daily is effictive and safe in patients with epilepsy with partial seizures
Phase III
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
224
Remegal 1500 mg for 12 weeks
Region psychiatric clinic
Kemerovo, Russia
Moscow regional psychiatric hospital
Moscow, Russia
State Medical University
Novosibirsk, Russia
State psychiatric hospital №6
Saint Petersburg, Russia
Seizure Frequency Reduction
The assessment of efficacy will be based on the reduction of total partial seizure frequency reported in the patient's diary during the Treatment phase.
Time frame: 12 weeks
Number of Seizure's-Free Days
Number seizure's-free days during the Maintenance phase
Time frame: 12 weeks
CGI
Clinical Global Impression of change (CGI) at the end of Titration and Maintenance phases
Time frame: 12 weeks
PGI
Patients' Global Impression of change (PGI) at the end of the Titration and Maintenance phases
Time frame: 12 weeks
QOLIE
Assessment of Quality of Life Instrument in Epilepsy (QOLIE) at the Baseline Visit and at the end of Maintenance Phase
Time frame: 14 weeks
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