Remegal Fixed Dose as Adjunctive Therapy in Patients With Partial Seizures

NCT01749046 | Completed Phase 3 DMC

• 2 other identifiers: 11-MPP02EPI11-МРР02ЕРI
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to determine weather Remegal in fixed dosage 1500 mg/daily is effictive and safe in patients with epilepsy with partial seizures

Conditions

Epilepsy; Simple Partial Seizures; Complex Partial Seizures; Partial Seizures With Secondary Generalization

Keywords

Epileptic seizures, Partial seizures

Outcome Measures

Primary Outcomes (1)

• Seizure Frequency Reduction

  The assessment of efficacy will be based on the reduction of total partial seizure frequency reported in the patient's diary during the Treatment phase.

  12 weeks

Secondary Outcomes (4)

• Number of Seizure's-Free Days

  12 weeks

• CGI

  12 weeks

• PGI

  12 weeks

• QOLIE

  14 weeks

Study Arms (2)

Remegal

EXPERIMENTAL

Remegal 1500 mg

Drug: Remegal

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Remegal

Interventions

Remegal DRUG

Remegal 1500 mg for 12 weeks

Also known as: Beprodon, AED

Placebo; Remegal

Eligibility Criteria

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

You may qualify if:

• Man or woman, aged from 18 to 65
• Diagnosis of epilepsy with simple and/or complex partial seizures both with or without secondary generalization based on the ILAE classification
• Results of at least one prior electroencephalogram (EEG) and magnetic resonance imaging (MRI)/computerized tomography scan no more than 5 years should confirm the diagnostic of partial seizures
• If seizures are simple partial ones, only patients with motor signs must be enrolled
• The onset date of partial seizures according to patient's report must be at least 2 years
• The patient must report an average of at least 8 partial seizures per 56 days prior to the baseline visit
• The patient must not have seizure-free period longer than 21 days during the 8 weeks prior to the baseline visit (i.e between V1 and V2)
• Patients must have been treated with at least 2 different AEDs within the last 2 years prior to the screening visit
• The patient is capable and would like to respect all protocol requirements, include to be available for the doctor's calls and doctor's appointments at any time, follow through all protocol procedures
• The patient agrees to self - report each seizure he has experienced between 2 visits, accurately and thoroughly, in a diary he'll be provided with

You may not qualify if:

• Patients suffering from non-epileptic seizures
• Patients having seizures that can't be counted due to clustering.
• History of primary generalized seizures
• History of status epilepticus within 12 months prior to the screening visit
• The patient has received not permitted concomitant medications
• The patient has a progressive structural lesion in the CNS, or a progressive encephalopathy
• The patient is pregnant (or planning to become pregnant during the study) or is a lactating woman
• The patient has used Remegal previously or participated in a clinical study within 24 weeks prior to the screening visit
• The patient has experienced of any somatic disorders or psychiatric diseases and conditions which, in the opinion of the investigator, lead to health worsening or influence on the patient ability to participate in the actual clinical study
• Vulnerable patients and individuals of majority age who are subject to legal protection or unable to express their consent
• The patient has a history of chronic alcohol consumption or drug abuse within 2 years prior to the screening visit
• The patient has a known history of a severe anaphylactic reaction or severe changes in blood tests
• ALT, AST, alkaline phosphatise, total bilirubin or serum creatinine level ≥ 2 times the upper limit of normal ranges
• Clinically important abnormalities on physical examination, vital signs, ECG or laboratory test results per-formed/obtained at the screening visit that may interfere with patient's safety, compliance, or study evaluations, ac-cording to the Investigator's opinion
• The patient has a clinically significant disease, surgical condition or recent chronic consumption of non-AED medications (within 4 weeks prior to the screening visit) that might be reasonably expected to interfere with drug absorption, distribution, metabolism, excretion

Sponsors & Collaborators

• Valexfarm: lead

Study Sites (9)

Region psychiatric clinic

Kemerovo, 650036, Russia

Location

Moscow regional psychiatric hospital

Moscow, 127083, Russia

Location

State Medical University

Novosibirsk, 630091, Russia

Location

State psychiatric hospital №6

Saint Petersburg, 193167, Russia

Location

State Medical University

Samara, 443099, Russia

Location

Republican psychiatric dispensary

Saransk, 430030, Russia

Location

State Medical Academy

Smolensk, 214019, Russia

Location

Medical unit of disel equipment

Yaroslavl, 150007, Russia

Location

Sverdlovsk region neuropsychiatric clinic

Yekaterinburg, 620036, Russia

Location

MeSH Terms

Conditions

Epilepsy; Epilepsies, Partial; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: December 13, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

RU (9)