Clinical trial NCT01749046: Remegal Fixed Dose as Adjunctive Therapy in Patients With Partial Seizures
Official title: Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose of Remegal as Adjunctive Therapy in Patients With Partial Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Simple Partial Seizures
Complex Partial Seizures
Partial Seizures With Secondary Generalization
Keywords: Epileptic seizures, Partial seizures
Lead sponsor: Valexfarm
Sponsor class: INDUSTRY
First posted: 2012-12-13
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: Phase III

Eligibility criteria: 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

Primary outcomes:
measure: Seizure Frequency Reduction
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Seizure's-Free Days
timeFrame: 12 weeks
measure: CGI
timeFrame: 12 weeks
measure: PGI
timeFrame: 12 weeks
measure: QOLIE
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk region neuropsychiatric clinic
city: Kemerovo
country: Russian Federation
facility: Region psychiatric clinic
city: Moscow
country: Russian Federation
facility: Moscow regional psychiatric hospital
city: Novosibirsk
country: Russian Federation
facility: State Medical University
city: Saint-Petersburg
country: Russian Federation
facility: State psychiatric hospital №6
city: Samara
country: Russian Federation
facility: State Medical University
city: Saransk
country: Russian Federation
facility: Republican psychiatric dispensary
city: Smolensk
country: Russian Federation
facility: State Medical Academy
city: Yaroslavl
country: Russian Federation
facility: Medical unit of disel equipment
Study officials:
References: