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EpilepsyPhase 3NCT01749046

Remegal Fixed Dose as Adjunctive Therapy in Patients With Partial Seizures

A Phase 3 study testing Remegal in people with Epilepsy and Simple Partial Seizures, run by Valexfarm at 9 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Remegal
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
224 participants
Where
9 sitesRussia
Study dates
Mar 2012to Dec 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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
  • QTc interval on the ECG performed at the screening visit above 500 ms
  • Diseases or concomitant medications that may prolong QTc interval

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Russia9 sites

  • Region psychiatric clinic

    Kemerovo, 650036

  • Moscow regional psychiatric hospital

    Moscow, 127083

  • State Medical University

    Novosibirsk, 630091

  • State psychiatric hospital №6

    Saint Petersburg, 193167

  • State Medical University

    Samara, 443099

  • Republican psychiatric dispensary

    Saransk, 430030

  • State Medical Academy

    Smolensk, 214019

  • Medical unit of disel equipment

    Yaroslavl, 150007

  • Sverdlovsk region neuropsychiatric clinic

    Yekaterinburg, 620036

Other trials in Russia

About this study

Official title: Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose of Remegal as Adjunctive Therapy in Patients With Partial Seizures

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

Read the detailed description

Phase III

Being tested
Remegal
Keywords
Epileptic seizures, Partial seizures
Medical subject headings
Epilepsy, Epilepsies, Partial, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemegalDrug

    Also called Beprodon, AED

    Remegal 1500 mg for 12 weeks

Study groups in NCT01749046
Study groupRoleWhat they receive
RemegalExperimentalRemegal 1500 mg
Receives: Drug: Remegal
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Remegal

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (4)

  1. Number of Seizure's-Free Days

    Number seizure's-free days during the Maintenance phase

    Measured: 12 weeks

  2. CGI

    Clinical Global Impression of change (CGI) at the end of Titration and Maintenance phases

    Measured: 12 weeks

  3. PGI

    Patients' Global Impression of change (PGI) at the end of the Titration and Maintenance phases

    Measured: 12 weeks

  4. QOLIE

    Assessment of Quality of Life Instrument in Epilepsy (QOLIE) at the Baseline Visit and at the end of Maintenance Phase

    Measured: 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionOct 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01749046
Sponsor's protocol ID
11-MPP02EPI
Other IDs
11-МРР02ЕРI
Status last verified
May 2017
First submitted
11 Dec 2012
Last updated
11 May 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remegal in people with Epilepsy and Simple Partial Seizures, run by Valexfarm at 9 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seizure Frequency Reduction (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01749046.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.

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