Remegal Different Doses in Patients With Refractory Partial Seizures

NCT01179854 | Completed Phase 2 DMC

• 1 other identifier: 2Р/КИ/Б
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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

Conditions

Drug Safety; Normal Drug Tolerance; Self Efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• efficacy

  Jan 2010 - Dec 2010

Study Arms (4)

500 mg

EXPERIMENTAL

Group of active treatment of Remegal 500 mg

Drug: Remegal

Remegal 750 mg

EXPERIMENTAL

Group of active treatment of Remegal 750 mg

Drug: Remegal

Remegal 1000 mg

EXPERIMENTAL

Group of active treatment of Remegal 1000 mg

Drug: Remegal

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Remegal

Interventions

Remegal DRUG

Drug/ placebo

Also known as: Remegal (beprodone)

500 mg; Placebo; Remegal 1000 mg; Remegal 750 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subject with non-epileptic events including psychogenic seizures that could be confused with seizures.
• Subject with seizures that cannot be counted due to clustering.
• Subject with a history of primary generalized seizures.
• Subject with a history of status epilepticus within the 12 months period prior to trial entry.
• Subject with concomitant treatment of felbamate or previous felbamate therapy within the last 6 months prior to trial entry.
• Subject with concomitant treatment of vigabatrin. Subjects with previous vigabatrin therapy must have had a visual field test prior to trial entry.
• Subject with a progressive structural lesion in the central nervous system or a progressive encephalopathy.
• Subject who received REMEGAL in a previous trial.
• Subject currently participating or who participated within the last two months in any trial of an investigational drug or experimental device.
• 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.
• 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.
• Subject with a history of chronic alcohol or drug abuse within the previous 2 years.
• 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.
• Subject with clinically significant abnormal vital signs.
• Subject with a known history of severe anaphylactic reaction or serious blood dyscrasias.

Sponsors & Collaborators

• Valexfarm: lead

Study Sites (4)

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

Barnaul, 656022, Russia

Location

Republican Dispensary

Saransk, 430030, Russia

Location

GOU VPO Volgograd State medicine university of roszdrav

Volgograd, 400131, Russia

Location

Sverdlovsk Regional Hospital

Yekaterinburg, 620905, Russia

Location

Study Officials

• Dorogov Nikolay, MD, PhD

  MUZ"City Clinic №4"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2010
• First Posted: August 11, 2010
• Study Start: September 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: September 1, 2011
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

RU (4)