Remegal Different Doses in Patients With Refractory Partial Seizures

Phase 2 Double-blind,Placebo-controlled Study for Evaluation of Efficiency, Safety,Tolerance and Pharmacokinetics of Different Doses of Remegal in Additional Therapy for Patients With Refractory Partial Seizures

The purpose of this study is to determine weather different doses of Remegal are effective,safety and tolerant in Additional Therapy for Patients With Refractory Partial Seizures and pharmacokinetics definition

Study Overview

• Status: Completed
• Conditions: Self Efficacy; Drug Safety; Normal Drug Tolerance
• Intervention / Treatment: Drug: Remegal

Detailed Description

Phase II

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • Barnaul, Russian Federation, 656022
    • KGUZ "U.K. Erdman Altai Regional psychiatric hospital"
  • Ekaterinburg, Russian Federation, 620905
    • Sverdlovsk Regional Hospital
  • Saransk, Russian Federation, 430030
    • Republican Dispensary
  • Volgograd, Russian Federation, 400131
    • GOU VPO Volgograd State medicine university of roszdrav

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:

1. Subject will report to have partial onset seizures for at least the last 2 years despite prior therapy with at least 2 different consecutive AEDs.
2. Subject will report an average of at least 4 partial onset seizures per 28 days prior to entry in the Baseline phase.
3. Seizure-free period will be no longer than 21 days in the 4-week period prior to entry in the Baseline phase.
4. Subject will be on stable dosage regimen of a maximum of 3 AEDs,.
5. The dosage of concomitant AED therapy will be kept constant for at least 4 weeks prior to entry into the Baseline phase.
6. 'Subject will receive information will be given time to think about their participation and will give their written informed consent.
7. Subject will be male or female between 18 and 65 years old.

8. Subject will have a diagnosis of epilepsy with simple partial seizures and/or complex-partial seizures both with or without secondary generalization according to the ILAE (1981):

   • The results of at least one prior electroencephalogram (EEG) and magnetic resonance imaging/computerized tomography scan should be consistent with the diagnosis of partial seizures.
   • In the case of simple partial seizures, only those who motor signs will be included.

Exclusion Criteria:

1. Subject with non-epileptic events including psychogenic seizures that could be confused with seizures.
2. Subject with seizures that cannot be counted due to clustering.
3. Subject with a history of primary generalized seizures.
4. Subject with a history of status epilepticus within the 12 months period prior to trial entry.
5. Subject with concomitant treatment of felbamate or previous felbamate therapy within the last 6 months prior to trial entry.
6. Subject with concomitant treatment of vigabatrin. Subjects with previous vigabatrin therapy must have had a visual field test prior to trial entry.
7. Subject with a progressive structural lesion in the central nervous system or a progressive encephalopathy.
8. Subject who received REMEGAL in a previous trial.
9. Subject currently participating or who participated within the last two months in any trial of an investigational drug or experimental device.
10. Pregnant or nursing women and/or those of childbearing potential who are not surgically sterile, two years postmenopausal or do not practice two combined methods of contraception, unless sexually abstinent, during the duration of the trial.
11. Subject with any medical or psychiatric condition, which in the opinion of the investigator could jeopardize the subject's health or would compromise the subject's ability to participate in this trial.
12. Subject with a history of chronic alcohol or drug abuse within the previous 2 years.
13. Subject with alanine amino transferase (ALT), aspartate amino transferase (AST), alkaline phosphatase, total bilirubin, or serum creatinine level more than or equal to 2 times the upper limit of normal.
14. Subject with clinically significant abnormal vital signs.
15. Subject with a known history of severe anaphylactic reaction or serious blood dyscrasias.
16. Subject with any other clinically significant disease, surgical condition or recent chronic consumption of non-AED medications (within the preceding four weeks prior to trial entry) that might reasonably have been expected to interfere with drug absorption, distribution, metabolism or excretion.
17. Subject taking one of the following medications influencing the central nervous system within four weeks prior to trial entry: neuroleptics, monoamine oxidase (MAO) inhibitors, anxiolytics, amphetamines, sedative antihistamines, tranquilizers, hypnotics, narcotic analgesics, except for medication taken as epileptic treatment.
18. Subject with confirmed clinically significant abnormality in ECG, including prolonged QTc interval.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Remegal; Drug/ placebo; Other Names: Remegal (beprodone)
Experimental: 500 mg; Group of active treatment of Remegal 500 mg	Drug: Remegal; Drug/ placebo; Other Names: Remegal (beprodone)
Experimental: Remegal 750 mg; Group of active treatment of Remegal 750 mg	Drug: Remegal; Drug/ placebo; Other Names: Remegal (beprodone)
Experimental: Remegal 1000 mg; Group of active treatment of Remegal 1000 mg	Drug: Remegal; Drug/ placebo; Other Names: Remegal (beprodone)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety and tolerability	The primary objective of the study is to evaluate the safety and tolerability of Remegal administered concomitantly with 1 - 3 antiepileptic drugs (AEDs) in subjects who currently have uncontrolled partial seizures with or without secondary generalization.	Jan 2010 - Dec 2010

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy	To assess the efficacy and its association with the Remegal dosages, and to evaluate the steady-state plasma concentrations of Remegal and concomitantly orally administered AEDs	Jan 2010 - Dec 2010

Collaborators and Investigators

• Sponsor: Valexfarm
• Investigators: Principal Investigator: Dorogov Nikolay, MD, PhD, MUZ"City Clinic №4"

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: July 30, 2010
• First Submitted That Met QC Criteria: August 10, 2010
• First Posted (Estimate): August 11, 2010

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

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures
• Other Study ID Numbers: 2Р/КИ/Б (Other Identifier: Valexfarm)