Partial EpilepsyPhase 3NCT00908349
Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
A Phase 3 study testing Oxcarbazepine XR in people with Partial Epilepsy, run by Supernus Pharmaceuticals, Inc. at 58 sites in 8 countries.
Trial summary
Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR) Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Partial Epilepsy
- What is being tested?
- Oxcarbazepine XR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 58 sitesin 8 countries
- Study dates
- Jun 2009to Nov 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent and agree to comply with study procedures.
- Male or female aged 18 to 66 years, inclusive.
- Successful completion of the 804P301 study.
- Sexually active women, unless surgically sterile (at least 6 months prior to Study Medication [SM] administration) or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to SM administration] sexual partner) for at least four weeks prior to SM administration, and must agree to continue using such precautions through the End of Study visit. Cessation of birth control after this point should be discussed with a responsible physician.
Who cannot join
- Clinically significant change in health status that, in the opinion of the Investigator, would prevent the subject from participating in this study or successfully completing this study.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Trial locations and contacts
58 sites in 8 countries.
58 sites in 8 countries
United States20 sites
Study site
Aurora, Colorado
Study site
Baytown, Texas
Study site
Bethesda, Maryland
Study site
Huntsville, Alabama
Study site
Jacksonville, Florida
Study site
Lexington, Kentucky
Study site
Little Rock, Arkansas
Study site
Miami, Florida
Study site
Missoula, Montana
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Northport, Alabama
Study site
Oklahoma City, Oklahoma
Study site
Phoenix, Arizona
Study site
Riverside, California
Study site
Sarasota, Florida
Study site
Springfield, Illinois
Study site
Temple, Texas
Study site
Tucson, Arizona
Study site
West Los Angeles, California
Russia10 sites
Study site
Kazan'
Study site
Kirov
Study site
Kursk
Study site
Moscow
Study site
Nizhny Novgorod
Study site
Novosibirsk
Study site
Pyatigorsk
Study site
Saint Petersburg
Study site
Samara
Study site
Smolensk
Mexico8 sites
Study site
Aguascalientes
Study site
Col. Guillermina, Durango
Study site
Col. Las Palmas, Chihuahua
Study site
Guadalajara, Jalisco
Study site
Mexico City, Mexico City
Study site
Puebla City
Study site
San Luis Potosí City, San Luis Potosí
Study site
Zapopan, Jalisco
Poland7 sites
Study site
Giżycko
Study site
Katowice
Study site
Krakow
Study site
Lodz
Study site
Lublin
Study site
Warsaw
Study site
Wilkowice
Bulgaria5 sites
Study site
Blagoevgrad
Study site
Pleven
Study site
Rousse
Study site
Sofia
Study site
Varna
Romania4 sites
Study site
Bucharest
Study site
Campulung Muscel
Study site
Cluj-Napoca
Study site
Craiova
About this study
Official title: Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)
Read the detailed description
NAP
- Conditions
- Partial Epilepsy
- Being tested
- Oxcarbazepine XR
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxcarbazepine XRDrug
Also called SPN-804O
Open Label Study
| Study group | Role | What they receive |
|---|---|---|
| Oxcarbazepine XR | Other | Open Label Study Receives: Drug: Oxcarbazepine XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Seizure Rate
Measured as change from baseline to end of study
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Partial EpilepsyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janet K Johnson, PhD, Study director, Supernus Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908349
- Sponsor's protocol ID
- 804P302
- Status last verified
- May 2017
- First submitted
- 22 May 2009
- Last updated
- 31 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
- ClinicalTrials.gov ID
- NCT00908349
- Acronym / sponsor ID
- 804P302
- Conditions
- Partial Epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 25 May 2009 (estimated)
- Results
- Posted 31 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)
Detailed description
NAP
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxcarbazepine XR | Other | Drug: Oxcarbazepine XROpen Label Study |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide written informed consent and agree to comply with study procedures.
- Male or female aged 18 to 66 years, inclusive.
- Successful completion of the 804P301 study.
- Sexually active women, unless surgically sterile (at least 6 months prior to Study Medication [SM] administration) or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to SM administration] sexual partner) for at least four weeks prior to SM administration, and must agree to continue using such precautions through the End of Study visit. Cessation of birth control after this point should be discussed with a responsible physician.
Key exclusion criteria (2 listed)
- Clinically significant change in health status that, in the opinion of the Investigator, would prevent the subject from participating in this study or successfully completing this study.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
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 XRAlso: SPN-804OOpen Label Study | Drug | Oxcarbazepine XR |
Primary outcome
Percent Change in Seizure Rate
Time frame: one year
Measured as change from baseline to end of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Janet K Johnson, PhD study director
Supernus Pharmaceuticals, Inc.
58 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxcarbazepine XR in people with Partial Epilepsy, run by Supernus Pharmaceuticals, Inc. at 58 sites in 8 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 4 inclusion and 2 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 31 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 58 sites in United States, Russia, Mexico, Poland, Bulgaria and 3 more countries. 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?
Yes. Results are posted in the registry (first posted 31 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Seizure Rate (time frame: one year). 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 31 May 2017.