Remegal Fixed Dose as Adjunctive Therapy in Patients With Partial Seizures

Valexfarm

Status and phase

Completed

Phase 3

Conditions

Epilepsy

Complex Partial Seizures

Partial Seizures With Secondary Generalization

Simple Partial Seizures

Treatments

Drug: Remegal

Study type

Interventional

Funder types

Industry

Identifiers

NCT01749046

11-МРР02ЕРI (Other Identifier)

11-MPP02EPI

Details and patient eligibility

About

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

Full description

Phase III

Enrollment

224 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Man or woman, aged from 18 to 65
Diagnosis of epilepsy with simple and/or complex partial seizures both with or without secondary generalization based on the ILAE classification
Results of at least one prior electroencephalogram (EEG) and magnetic resonance imaging (MRI)/computerized tomography scan no more than 5 years should confirm the diagnostic of partial seizures
If seizures are simple partial ones, only patients with motor signs must be enrolled
The onset date of partial seizures according to patient's report must be at least 2 years
The patient must report an average of at least 8 partial seizures per 56 days prior to the baseline visit
The patient must not have seizure-free period longer than 21 days during the 8 weeks prior to the baseline visit (i.e between V1 and V2)
Patients must have been treated with at least 2 different AEDs within the last 2 years prior to the screening visit
The patient is capable and would like to respect all protocol requirements, include to be available for the doctor's calls and doctor's appointments at any time, follow through all protocol procedures
The patient agrees to self - report each seizure he has experienced between 2 visits, accurately and thoroughly, in a diary he'll be provided with

Exclusion criteria

Patients suffering from non-epileptic seizures
Patients having seizures that can't be counted due to clustering.
History of primary generalized seizures
History of status epilepticus within 12 months prior to the screening visit
The patient has received not permitted concomitant medications
The patient has a progressive structural lesion in the CNS, or a progressive encephalopathy
The patient is pregnant (or planning to become pregnant during the study) or is a lactating woman
The patient has used Remegal previously or participated in a clinical study within 24 weeks prior to the screening visit
The patient has experienced of any somatic disorders or psychiatric diseases and conditions which, in the opinion of the investigator, lead to health worsening or influence on the patient ability to participate in the actual clinical study
Vulnerable patients and individuals of majority age who are subject to legal protection or unable to express their consent
The patient has a history of chronic alcohol consumption or drug abuse within 2 years prior to the screening visit
The patient has a known history of a severe anaphylactic reaction or severe changes in blood tests
ALT, AST, alkaline phosphatise, total bilirubin or serum creatinine level ≥ 2 times the upper limit of normal ranges
Clinically important abnormalities on physical examination, vital signs, ECG or laboratory test results per-formed/obtained at the screening visit that may interfere with patient's safety, compliance, or study evaluations, ac-cording to the Investigator's opinion
The patient has a clinically significant disease, surgical condition or recent chronic consumption of non-AED medications (within 4 weeks prior to the screening visit) that might be reasonably expected to interfere with drug absorption, distribution, metabolism, excretion
QTc interval on the ECG performed at the screening visit above 500 ms
Diseases or concomitant medications that may prolong QTc interval