Remegal Fixed Dose as Adjunctive Therapy in Patients With Partial Seizures

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

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

Study Overview

• Status: Completed
• Conditions: Epilepsy; Complex Partial Seizures; Simple Partial Seizures; Partial Seizures With Secondary Generalization
• Intervention / Treatment: Drug: Remegal

Detailed Description

Phase III

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Ekaterinburg, Russian Federation, 620036
    • Sverdlovsk region neuropsychiatric clinic
  • Kemerovo, Russian Federation, 650036
    • Region psychiatric clinic
  • Moscow, Russian Federation, 127083
    • Moscow regional psychiatric hospital
  • Novosibirsk, Russian Federation, 630091
    • State Medical University
  • Saint-Petersburg, Russian Federation, 193167
    • State psychiatric hospital №6
  • Samara, Russian Federation, 443099
    • State Medical University
  • Saransk, Russian Federation, 430030
    • Republican psychiatric dispensary
  • Smolensk, Russian Federation, 214019
    • State Medical Academy
  • Yaroslavl, Russian Federation, 150007
    • Medical unit of disel equipment

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Remegal; Remegal 1500 mg for 12 weeks; Other Names: Beprodon; AED
Experimental: Remegal; Remegal 1500 mg	Drug: Remegal; Remegal 1500 mg for 12 weeks; Other Names: Beprodon; AED

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Seizure's-Free Days	Number seizure's-free days during the Maintenance phase	12 weeks
CGI	Clinical Global Impression of change (CGI) at the end of Titration and Maintenance phases	12 weeks
PGI	Patients' Global Impression of change (PGI) at the end of the Titration and Maintenance phases	12 weeks
QOLIE	Assessment of Quality of Life Instrument in Epilepsy (QOLIE) at the Baseline Visit and at the end of Maintenance Phase	14 weeks

Collaborators and Investigators

• Sponsor: Valexfarm

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 11, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (Estimate): December 13, 2012

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Epileptic seizures, Partial seizures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Epilepsies, Partial
• Other Study ID Numbers: 11-MPP02EPI; 11-МРР02ЕРI (Other Identifier: Ministry of Health of Russian Federation)