COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Remegal Fixed Dose as Adjunctive Therapy in Patients With Partial Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01749046
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : May 11, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Epilepsy Simple Partial Seizures Complex Partial Seizures Partial Seizures With Secondary Generalization Drug: Remegal Phase 3

Detailed Description:
Phase III

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: Remegal
Remegal 1500 mg
Drug: Remegal
Remegal 1500 mg for 12 weeks
Other Names:
  • Beprodon
  • AED

Placebo Comparator: Placebo
Drug: Remegal
Remegal 1500 mg for 12 weeks
Other Names:
  • Beprodon
  • AED

Primary Outcome Measures :
  1. Seizure Frequency Reduction [ Time Frame: 12 weeks ]
    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 :
  1. Number of Seizure's-Free Days [ Time Frame: 12 weeks ]
    Number seizure's-free days during the Maintenance phase

  2. CGI [ Time Frame: 12 weeks ]
    Clinical Global Impression of change (CGI) at the end of Titration and Maintenance phases

  3. PGI [ Time Frame: 12 weeks ]
    Patients' Global Impression of change (PGI) at the end of the Titration and Maintenance phases

  4. QOLIE [ Time Frame: 14 weeks ]
    Assessment of Quality of Life Instrument in Epilepsy (QOLIE) at the Baseline Visit and at the end of Maintenance Phase

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01749046

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

Layout table for additonal information
Responsible Party: Valexfarm Identifier: NCT01749046    
Other Study ID Numbers: 11-MPP02EPI
11-МРР02ЕРI ( Other Identifier: Ministry of Health of Russian Federation )
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Keywords provided by Valexfarm:
Epileptic seizures, Partial seizures
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms