Remegal Fixed Dose as Adjunctive Therapy in Patients With Partial Seizures

NCT ID: NCT01749046

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-12-31

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

Conditions

Epilepsy; Simple Partial Seizures; Complex Partial Seizures; Partial Seizures With Secondary Generalization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Remegal

Remegal 1500 mg

Group Type: EXPERIMENTAL

Remegal

Intervention Type: DRUG

Remegal 1500 mg for 12 weeks

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Remegal

Intervention Type: DRUG

Remegal 1500 mg for 12 weeks

Interventions

Remegal

Remegal 1500 mg for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Beprodon; AED

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valexfarm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Region psychiatric clinic

Kemerovo, , Russia

Moscow regional psychiatric hospital

Moscow, , Russia

State Medical University

Novosibirsk, , Russia

State psychiatric hospital №6

Saint Petersburg, , Russia

State Medical University

Samara, , Russia

Republican psychiatric dispensary

Saransk, , Russia

State Medical Academy

Smolensk, , Russia

Medical unit of disel equipment

Yaroslavl, , Russia

Sverdlovsk region neuropsychiatric clinic

Yekaterinburg, , Russia

Countries

Russia

Other Identifiers

11-МРР02ЕРI

Identifier Type: OTHER

Identifier Source: secondary_id

11-MPP02EPI

Identifier Type: -

Identifier Source: org_study_id