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Remegal Different Doses in Patients With Refractory Partial Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valexfarm
ClinicalTrials.gov Identifier:
NCT01179854
First received: July 30, 2010
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Drug Safety
Normal Drug Tolerance
Self Efficacy
Drug: Remegal
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Valexfarm:

Primary Outcome Measures:
  • safety and tolerability [ Time Frame: Jan 2010 - Dec 2010 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • efficacy [ Time Frame: Jan 2010 - Dec 2010 ] [ Designated as safety issue: No ]
    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


Enrollment: 60
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 500 mg
Group of active treatment of Remegal 500 mg
Drug: Remegal
Drug/ placebo
Other Name: Remegal (beprodone)
Experimental: Remegal 750 mg
Group of active treatment of Remegal 750 mg
Drug: Remegal
Drug/ placebo
Other Name: Remegal (beprodone)
Experimental: Remegal 1000 mg
Group of active treatment of Remegal 1000 mg
Drug: Remegal
Drug/ placebo
Other Name: Remegal (beprodone)
Placebo Comparator: Placebo
Placebo

Detailed Description:

Phase II

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01179854

Locations
Russian Federation
KGUZ "U.K. Erdman Altai Regional psychiatric hospital"
Barnaul, Russian Federation, 656022
Sverdlovsk Regional Hospital
Ekaterinburg, Russian Federation, 620905
Republican Dispensary
Saransk, Russian Federation, 430030
GOU VPO Volgograd State medicine university of roszdrav
Volgograd, Russian Federation, 400131
Sponsors and Collaborators
Valexfarm
Investigators
Principal Investigator: Dorogov Nikolay, MD, PhD MUZ"City Clinic №4"
  More Information

No publications provided

Responsible Party: Valexfarm
ClinicalTrials.gov Identifier: NCT01179854     History of Changes
Other Study ID Numbers: 2Р/КИ/Б, 2Р/КИ/Б, 2Р/КИ/Б
Study First Received: July 30, 2010
Last Updated: December 5, 2012
Health Authority: Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Russia: FSI Scientific Center of Expertise of Medical Application

ClinicalTrials.gov processed this record on November 25, 2014