EpilepsyPhase 3NCT00050947
Pediatric Epilepsy Study
A Phase 3 study testing oxcarbazepine in people with Epilepsy, run by Novartis Pharmaceuticals at 30 sites in 4 countries.
Trial summary
This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- oxcarbazepine
- How many people
- 94 participants
- Where
- 30 sitesin 4 countries
- Study dates
- Jul 2002to Feb 2004
- 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 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have a diagnosis of partial seizures
- Have 2-30 seizures per week while on a stable dose of one anti-epileptic drug or be a patient recently diagnosed with partial seizures and currently receiving no seizure medication
- Be willing to be hospitalized for up to 5 days
- Weigh a minimum of 6.6 lbs
- Have had a previous CAT scan/MRI confirming the absence of space occupying lesions or progressive neurological disease
- Have normal laboratory results
Show all 20Show fewer
- EXCLUSION CRITERIA: To enter this study, a patient must not have or be:
- Seizures caused by metabolic disturbance, toxic exposure, or active infection
- A primary diagnosis of generalized epilepsy (exception - secondarily generalized seizures)
- A history of status epilepticus within 30 days
- Seizures not related to epilepsy
- This study has some AED restrictions
- Serum sodium levels <135 mEq/L
- Significant heart, breathing, kidney, stomach, liver, blood, or cancer disorder requiring treatment/therapy
- A history of chronic infection (e.g., hepatitis or HIV)
- Significant electrocardiogram (ECG) abnormalities
- A nursing mother taking anti-convulsant drugs
- A history of substance abuse (including alcohol)
- Previously demonstrated sensitivity/allergic reaction to Trileptal or related compounds
- Used experimental medication within 30 days of entering this study
Who cannot join
None listed.
Trial locations and contacts
30 sites in 4 countries.
30 sites in 4 countries
United States25 sites
Study site
Akron, Ohio, 44308
Study site
Ann Arbor, Michigan, 48109
Study site
Atlanta, Georgia, 30342
Study site
Birmingham, Alabama, 35233
Study site
Buffalo, New York, 14222
Study site
Chesterfields, Missouri, 63017
Study site
Cincinnati, Ohio, 45229
Study site
Cleveland, Ohio, 44106
Study site
Denver, Colorado, 80218
Study site
Duluth, Minnesota, 55805
Study site
Fort Worth, Texas, 76104
Study site
Houston, Texas, 77030
Study site
Madera, California, 93638
Study site
Miami, Florida, 33155
Study site
Mobile, Alabama, 36693
Study site
New York, New York, 10016
Study site
Orange, California, 92868
Study site
Philadelphia, Pennsylvania, 19104
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Portland, Oregon, 97201
Study site
Raleigh, North Carolina, 27607
Study site
Saint Paul, Minnesota, 55102
Study site
Spartenberg, South Carolina, 29303
Study site
St Louis, Missouri, 63110
Study site
Tampa, Florida, 33607
Germany3 sites
Study site
Jena, 07740
Study site
Kehl-Kork, 77694
Study site
Kiel, 24105
About this study
Official title: A Multicenter, Rater-blind, Randomized, Age-stratified, Parallel-group Study Comparing Two Doses of Oxcarbazepine as Monotherapy in Pediatric Patients With Inadequately-controlled Partial Seizures.
This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.
- Conditions
- Epilepsy
- Being tested
- oxcarbazepine
- Keywords
- partial seizures
- Medical subject headings
- Epilepsy, Seizures
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.
Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3.
Secondary outcomes (1)
Percentage of patients meeting one of the exit criteria and the electrographic partial seizure frequency/24 hours during the treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2003 (estimated)
- Study startJul 2002
- Primary completionFeb 2004
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050947
- Sponsor's protocol ID
- CTRI476E2339
- Status last verified
- Nov 2011
- First submitted
- 30 Dec 2002
- Last updated
- 23 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Rater-blind, Randomized, Age-stratified, Parallel-group Study Comparing Two Doses of Oxcarbazepine as Monotherapy in Pediatric Patients With Inadequately-controlled Partial Seizures.
- ClinicalTrials.gov ID
- NCT00050947
- Acronym / sponsor ID
- CTRI476E2339
- Conditions
- Epilepsy
- Keywords
- partial seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 1 Jan 2003 (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 will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (20 listed)
- Have a diagnosis of partial seizures
- Have 2-30 seizures per week while on a stable dose of one anti-epileptic drug or be a patient recently diagnosed with partial seizures and currently receiving no seizure medication
- Be willing to be hospitalized for up to 5 days
- Weigh a minimum of 6.6 lbs
- Have had a previous CAT scan/MRI confirming the absence of space occupying lesions or progressive neurological disease
Key exclusion criteria (0 listed)
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
Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3.
1 secondary outcome
Percentage of patients meeting one of the exit criteria and the electrographic partial seizure frequency/24 hours during the treatment phase
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 23 Nov 2011.
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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 director
Novartis Pharmaceuticals
30 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oxcarbazepine in people with Epilepsy, run by Novartis Pharmaceuticals at 30 sites in 4 countries.
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 20 inclusion and 0 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 23 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Germany, Brazil, Mexico. 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 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?
Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3.. 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 23 Nov 2011.