Remegal Fixed Dose as Adjunctive Therapy in Patients With Partial Seizures

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Valexfarm
Sponsor:
Information provided by (Responsible Party):
Valexfarm
ClinicalTrials.gov Identifier:
NCT01749046
First received: December 11, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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


Condition Intervention Phase
Epilepsy
Simple Partial Seizures
Complex Partial Seizures
Partial Seizures With Secondary Generalization
Drug: Remegal
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Valexfarm:

Primary Outcome Measures:
  • Seizure Frequency Reduction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number seizure's-free days during the Maintenance phase

  • CGI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Clinical Global Impression of change (CGI) at the end of Titration and Maintenance phases

  • PGI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Patients' Global Impression of change (PGI) at the end of the Titration and Maintenance phases

  • QOLIE [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    Assessment of Quality of Life Instrument in Epilepsy (QOLIE) at the Baseline Visit and at the end of Maintenance Phase


Estimated Enrollment: 224
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remegal
Remegal 1500 mg
Drug: Remegal
Remegal 1500 mg for 12 weeks
Other Names:
  • Beprodon
  • AED
Placebo Comparator: Placebo
Placebo

Detailed Description:

Phase III

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749046

Contacts
Contact: Svetlana Antonova, MD, PhD +74959210577 svetlana.antonova@crobiomed.com

Locations
Russian Federation
Sverdlovsk region neuropsychiatric clinic Recruiting
Ekaterinburg, Russian Federation, 620036
Contact: Marina Nesterova, MD, PhD         
Principal Investigator: Marina Nesterova, MD, PhD         
Region psychiatric clinic Recruiting
Kemerovo, Russian Federation, 650036
Contact: Vladimir Gordeev, MD         
Principal Investigator: Vladimir Gordeev, MD         
Moscow regional psychiatric hospital Recruiting
Moscow, Russian Federation, 127083
Contact: Valeryi Evtushcenko, MD, PhD         
Principal Investigator: Valeryi Evtushcenko, MD, PhD         
State Medical University Recruiting
Novosibirsk, Russian Federation, 630091
Contact: Olga Doronina, MD, PhD         
Principal Investigator: Olga Doronina, MD, PhD         
State psychiatric hospital №6 Recruiting
Saint-Petersburg, Russian Federation, 193167
Contact: Irina Larina, MD, PhD         
Principal Investigator: Mikhail Kissin, MD, PhD         
State Medical University Recruiting
Samara, Russian Federation, 443099
Contact: Irina Poverennova, MD, PhD         
Principal Investigator: Irina Poverennova, MD, PhD         
Republican psychiatric dispensary Recruiting
Saransk, Russian Federation, 430030
Contact: Elena Kuldirkaeva, MD         
Principal Investigator: Elena Kuldirkaeva, MD         
State Medical Academy Recruiting
Smolensk, Russian Federation, 214019
Contact: Natalya Maslova, MD         
Principal Investigator: Natalya Maslova, MD         
Medical unit of disel equipment Active, not recruiting
Yaroslavl, Russian Federation, 150007
Sponsors and Collaborators
Valexfarm
  More Information

No publications provided

Responsible Party: Valexfarm
ClinicalTrials.gov Identifier: NCT01749046     History of Changes
Other Study ID Numbers: 11-MPP02EPI, 11-МРР02ЕРI
Study First Received: December 11, 2012
Last Updated: December 11, 2012
Health Authority: Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation

Keywords provided by Valexfarm:
Epileptic seizures, Partial seizures

Additional relevant MeSH terms:
Seizures
Epilepsies, Partial
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014