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Remegal Different Doses in Patients With Refractory Partial Seizures | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT01179854•Valexfarm

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.
+8 more criteria

Locations (4)

KGUZ "U.K. Erdman Altai Regional psychiatric hospital"

Barnaul, Russia

Republican Dispensary

Saransk, Russia

GOU VPO Volgograd State medicine university of roszdrav

Volgograd, Russia

Sverdlovsk Regional Hospital

Yekaterinburg, Russia

Key Dates

Start Date

September 1, 2009

Primary Completion Date

November 1, 2010

Completion Date

September 1, 2011

Last Updated

May 11, 2017

Enrollment

ACTUAL participants

Conditions

Drug SafetyNormal Drug ToleranceSelf Efficacy

Interventions

Remegal

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 11, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Remegal Different Doses in Patients With Refractory Partial Seizures

Inclusion Criteria

Exclusion Criteria

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