Clinical trial NCT01179854: Remegal Different Doses in Patients With Refractory Partial Seizures
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Drug Safety
Normal Drug Tolerance
Self Efficacy
Lead sponsor: Valexfarm
Sponsor class: INDUSTRY
First posted: 2010-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: Phase II

Eligibility 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.

Primary outcomes:
measure: safety and tolerability
timeFrame: Jan 2010 - Dec 2010
Secondary outcomes:
measure: efficacy
timeFrame: Jan 2010 - Dec 2010
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: KGUZ "U.K. Erdman Altai Regional psychiatric hospital"
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Hospital
city: Saransk
country: Russian Federation
facility: Republican Dispensary
city: Volgograd
country: Russian Federation
facility: GOU VPO Volgograd State medicine university of roszdrav
Study officials:
affiliation: MUZ"City Clinic №4"
name: Dorogov Nikolay, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: