The purpose of this study is to determine weather different doses of Remegal are effective,safety and tolerant in Additional Therapy for Patients With Refractory Partial Seizures and pharmacokinetics definition
Phase II
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Drug/ placebo
KGUZ "U.K. Erdman Altai Regional psychiatric hospital"
Barnaul, Russia
Republican Dispensary
Saransk, Russia
GOU VPO Volgograd State medicine university of roszdrav
Volgograd, Russia
Sverdlovsk Regional Hospital
Yekaterinburg, Russia
safety and tolerability
The primary objective of the study is to evaluate the safety and tolerability of Remegal administered concomitantly with 1 - 3 antiepileptic drugs (AEDs) in subjects who currently have uncontrolled partial seizures with or without secondary generalization.
Time frame: Jan 2010 - Dec 2010
efficacy
To assess the efficacy and its association with the Remegal dosages, and to evaluate the steady-state plasma concentrations of Remegal and concomitantly orally administered AEDs
Time frame: Jan 2010 - Dec 2010
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