Epilepsy, Partial SeizuresPhase 4NCT00275925
Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures
A Phase 4 study testing Oxcarbazepine in people with Epilepsy, Partial Seizures, run by Novartis at 7 sites in Russia.
Trial summary
This study is aimed to evaluate the efficacy, safety and tolerability of oxcarbazepine monotherapy in adults with partial seizures. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Epilepsy, Partial Seizures
- What is being tested?
- Oxcarbazepine
- How many people
- 80 participants
- Where
- 7 sitesRussia
- Study dates
- Dec 2005to Mar 2007
- Phase
- Phase 4
- 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 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- males and females, 18 - 70 years of age;
- diagnosis of epilepsy, partial seizures;
- ineffective or intolerable present therapy with 1 antiepileptic drug, or none of previous therapy with antiepileptic drugs
Who cannot join
- progressive lesion of brain revealed by CT/MRI that performed no earlier than 2 years prior to screening;
- non-epileptic seizures;
- drug or alcohol dependence during a year prior to screening;
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Russia7 sites
Epilepsy Department of the Moscow Research Institute of Psychiatry
Moscow
Neurology and Neurosurgery Department of the Moscow State Medico-stomatology University
Moscow
Neurology and Neurosurgery Department of the Russian State Medical University
Moscow
Neurology Department of I.M. Sechenov Moscow Medical Academy
Moscow
Neurology Department of Pediatric faculty of the Russian State Medical University
Moscow
Neurology Department of the Moscow region Research Institute named after M.F. Vladimirskiy
Moscow
Epilepsy Department of the V.M. Bekhterev Sant-Petersburg Psychoneurology Institute
Saint Petersburg
About this study
Official title: A 24-Week Prospective, Open-Label, Multicenter Study to Evaluate the Effect on Seizure Frequency, Safety and Tolerability of Oxcarbazepine Monotherapy in Adult Patients With Partial Seizures
This study is aimed to evaluate the efficacy, safety and tolerability of oxcarbazepine monotherapy in adults with partial seizures.
- Conditions
- Epilepsy, Partial Seizures
- Being tested
- Oxcarbazepine
- Keywords
- partial epilepsy, oxcarbazepine, adults
- Medical subject headings
- Epilepsy, Seizures, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxcarbazepineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Epileptic activity at electroencephalography in rest
Flash light and hyperventilation test with electroencephalography
Frequency of epileptic episodes according to patient's diary
Electrocardiogram analysis for rhythm and conduction
Blood test for sodium, hepatic enzymes and blood cells
Secondary outcomes (4)
Quality of Life assessment at baseline, last visit
Tolerability and safety of 24 week's treatment with oxcarbazepine monotherapy in adult patients with partial seizures
Rate of patients with total and partial control of epilepsy
Rate of patients requiring additional antiepileptic drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startDec 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Partial SeizuresStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275925
- Sponsor's protocol ID
- CTRI476BRU01
- Status last verified
- Nov 2007
- First submitted
- 11 Jan 2006
- Last updated
- 30 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-Week Prospective, Open-Label, Multicenter Study to Evaluate the Effect on Seizure Frequency, Safety and Tolerability of Oxcarbazepine Monotherapy in Adult Patients With Partial Seizures
- ClinicalTrials.gov ID
- NCT00275925
- Acronym / sponsor ID
- CTRI476BRU01
- Conditions
- Epilepsy, Partial Seizures
- Keywords
- partial epilepsy, oxcarbazepine, adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 12 Jan 2006 (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.
This study is aimed to evaluate the efficacy, safety and tolerability of oxcarbazepine monotherapy in adults with partial seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- males and females, 18 - 70 years of age;
- diagnosis of epilepsy, partial seizures;
- ineffective or intolerable present therapy with 1 antiepileptic drug, or none of previous therapy with antiepileptic drugs
Key exclusion criteria (4 listed)
- progressive lesion of brain revealed by CT/MRI that performed no earlier than 2 years prior to screening;
- non-epileptic seizures;
- drug or alcohol dependence during a year prior to screening;
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| Oxcarbazepine | Drug | – |
Primary outcome
Epileptic activity at electroencephalography in rest
Flash light and hyperventilation test with electroencephalography
Frequency of epileptic episodes according to patient's diary
Electrocardiogram analysis for rhythm and conduction
Blood test for sodium, hepatic enzymes and blood cells
4 secondary outcomes
Quality of Life assessment at baseline, last visit
Tolerability and safety of 24 week's treatment with oxcarbazepine monotherapy in adult patients with partial seizures
Rate of patients with total and partial control of epilepsy
Rate of patients requiring additional antiepileptic drugs
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 30 Nov 2007.
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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.
Novartis Pharmaceuticals study chair
Novartis Pharmaceuticals
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxcarbazepine in people with Epilepsy, Partial Seizures, run by Novartis at 7 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 3 inclusion and 4 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 30 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Epileptic activity at electroencephalography in rest. The study lists 5 primary outcomes in all. 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 30 Nov 2007.