Drug SafetyPhase 2NCT01179854
Remegal Different Doses in Patients With Refractory Partial Seizures
A Phase 2 study testing Remegal in people with Drug Safety and Normal Drug Tolerance, run by Valexfarm at 4 sites in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Drug Safety, Normal Drug Tolerance, Self Efficacy
- What is being tested?
- Remegal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesRussia
- Study dates
- Sep 2009to Sep 2011
- Phase
- Phase 2
- 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
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
- 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.
- Subject with confirmed clinically significant abnormality in ECG, including prolonged QTc interval.
Trial locations and contacts
4 sites in 1 country.
Russia4 sites
KGUZ "U.K. Erdman Altai Regional psychiatric hospital"
Barnaul, 656022
Republican Dispensary
Saransk, 430030
GOU VPO Volgograd State medicine university of roszdrav
Volgograd, 400131
Sverdlovsk Regional Hospital
Yekaterinburg, 620905
About this study
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
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
Read the detailed description
Phase II
- Conditions
- Drug Safety, Normal Drug Tolerance, Self Efficacy
- Being tested
- Remegal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemegalDrug
Also called Remegal (beprodone)
Drug/ placebo
| Study group | Role | What they receive |
|---|---|---|
| 500 mg | Experimental | Group of active treatment of Remegal 500 mg Receives: Drug: Remegal |
| Remegal 750 mg | Experimental | Group of active treatment of Remegal 750 mg Receives: Drug: Remegal |
| Remegal 1000 mg | Experimental | Group of active treatment of Remegal 1000 mg Receives: Drug: Remegal |
| Placebo | Placebo comparator | Placebo Receives: Drug: Remegal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Jan 2010 - Dec 2010
Secondary outcomes (1)
efficacy
To assess the efficacy and its association with the Remegal dosages, and to evaluate the steady-state plasma concentrations of Remegal and concomitantly orally administered AEDs
Measured: Jan 2010 - Dec 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startSep 2009
- Primary completionNov 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valexfarm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dorogov Nikolay, MD, PhD, Principal investigator, MUZ"City Clinic №4"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179854
- Sponsor's protocol ID
- 2Р/КИ/Б
- Other IDs
- 2Р/КИ/Б, 2Р/КИ/Б
- Status last verified
- May 2017
- First submitted
- 30 Jul 2010
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01179854
- Acronym / sponsor ID
- 2Р/КИ/Б
- Conditions
- Drug Safety, Normal Drug Tolerance, Self Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ValexfarmIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 500 mg | Experimental | Drug: RemegalGroup of active treatment of Remegal 500 mg |
| Remegal 750 mg | Experimental | Drug: RemegalGroup of active treatment of Remegal 750 mg |
| Remegal 1000 mg | Experimental | Drug: RemegalGroup of active treatment of Remegal 1000 mg |
| Placebo | Placebo comparator | Drug: RemegalPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemegalAlso: Remegal (beprodone)Drug/ placebo | Drug | 500 mg, Placebo, Remegal 1000 mg, Remegal 750 mg |
Primary outcome
safety and tolerability
Time frame: Jan 2010 - Dec 2010
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.
1 secondary outcome
efficacy
Time frame: Jan 2010 - Dec 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorogov Nikolay, MD, PhD principal investigator
MUZ"City Clinic №4"
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Remegal in people with Drug Safety and Normal Drug Tolerance, run by Valexfarm at 4 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 18 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 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
safety and tolerability (time frame: Jan 2010 - Dec 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.