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Remegal Fixed Dose as Adjunctive Therapy in Patients With Partial Seizures

Primary Purpose

Epilepsy, Simple Partial Seizures, Complex Partial Seizures

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Remegal
Sponsored by
Valexfarm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epileptic seizures, Partial seizures

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sverdlovsk region neuropsychiatric clinic
  • Region psychiatric clinic
  • Moscow regional psychiatric hospital
  • State Medical University
  • State psychiatric hospital №6
  • State Medical University
  • Republican psychiatric dispensary
  • State Medical Academy
  • Medical unit of disel equipment

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Remegal

Placebo

Arm Description

Remegal 1500 mg

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 11, 2012
Last Updated
May 10, 2017
Sponsor
Valexfarm
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1. Study Identification

Unique Protocol Identification Number
NCT01749046
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valexfarm

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Simple Partial Seizures, Complex Partial Seizures, Partial Seizures With Secondary Generalization
Keywords
Epileptic seizures, Partial seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remegal
Arm Type
Experimental
Arm Description
Remegal 1500 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Remegal
Other Intervention Name(s)
Beprodon, AED
Intervention Description
Remegal 1500 mg for 12 weeks
Primary Outcome Measure Information:
Title
Seizure Frequency Reduction
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Seizure's-Free Days
Description
Number seizure's-free days during the Maintenance phase
Time Frame
12 weeks
Title
CGI
Description
Clinical Global Impression of change (CGI) at the end of Titration and Maintenance phases
Time Frame
12 weeks
Title
PGI
Description
Patients' Global Impression of change (PGI) at the end of the Titration and Maintenance phases
Time Frame
12 weeks
Title
QOLIE
Description
Assessment of Quality of Life Instrument in Epilepsy (QOLIE) at the Baseline Visit and at the end of Maintenance Phase
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Sverdlovsk region neuropsychiatric clinic
City
Ekaterinburg
ZIP/Postal Code
620036
Country
Russian Federation
Facility Name
Region psychiatric clinic
City
Kemerovo
ZIP/Postal Code
650036
Country
Russian Federation
Facility Name
Moscow regional psychiatric hospital
City
Moscow
ZIP/Postal Code
127083
Country
Russian Federation
Facility Name
State Medical University
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
State psychiatric hospital №6
City
Saint-Petersburg
ZIP/Postal Code
193167
Country
Russian Federation
Facility Name
State Medical University
City
Samara
ZIP/Postal Code
443099
Country
Russian Federation
Facility Name
Republican psychiatric dispensary
City
Saransk
ZIP/Postal Code
430030
Country
Russian Federation
Facility Name
State Medical Academy
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Medical unit of disel equipment
City
Yaroslavl
ZIP/Postal Code
150007
Country
Russian Federation

12. IPD Sharing Statement

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Remegal Fixed Dose as Adjunctive Therapy in Patients With Partial Seizures

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