Partial Onset SeizuresPhase 2/3NCT00975715
Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures
A Phase 2/3 study testing TRI476 and Benzodiazepines in people with Partial Onset Seizures, run by Novartis Pharmaceuticals at 25 sites in Japan.
Trial summary
This study is designed to provide short term efficacy and safety data of TRI476 in children with inadequately-controlled partial seizures. Patients will be randomized into either drug treatment or placebo group at 1:1 ratio, and receive their respective treatment for 8 weeks. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Partial Onset Seizures
- What is being tested?
- TRI476 and Benzodiazepines
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 25 sitesJapan
- Study dates
- Sep 2009to Oct 2012
- Phase
- Phase 2/3
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female outpatients, aged 4 to 14 years (inclusive), with a minimum body weight of 15 kg.
- A diagnosis of partial onset seizures, which include the seizure subtypes of simple, complex, and secondarily generalized seizures (based on the International League Against Epilepsy (ILAE) Classification, as modified in 1981).
Who cannot join
- A document history of generalized status epileptics in the past 6 months.
- Seizures having a metabolic, neoplastic, or active infectious origin.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Japan25 sites
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8431
Novartis Investigative Site
Chūō, Yamanashi, 409-3898
Novartis Investigative Site
Fukuoka, Fukuoka, 814-0180
Novartis Investigative Site
Gifu, Gifu, 502-8558
Novartis Investigative Site
Higashimatsuyama-shi, Saitama, 355-0008
Novartis Investigative Site
Himeji, Hyōgo, 670-8540
Novartis Investigative Site
Kameda-gun, Hokkaido, 041-1111
Novartis Investigative Site
Kashiwazaki, Niigata, 945-8585
Novartis Investigative Site
Kobe, Hyōgo, 658-0032
Novartis Investigative Site
Kōshi, Kumamoto, 861-1196
Novartis Investigative Site
Kurashiki, Okayama-ken, 710-8522
Novartis Investigative Site
Matsuyama, Ehime, 790-8524
Novartis Investigative Site
Moriyama-shi, Shiga, 524-0022
Novartis Investigative Site
Nagoya, Aichi-ken, 460-0004
Novartis Investigative Site
Neyagawa, Osaka, 572-0085
Novartis Investigative Site
Niigata, Niigata, 950-2085
Novartis Investigative Site
Ohbu, Aichi-ken, 474-0031
Novartis Investigative Site
Okayama, Okayama-ken, 700-8558
Novartis Investigative Site
Saitama, Saitama, 339-8551
Novartis Investigative Site
Sapporo, Hokkaido, 060-8648
Novartis Investigative Site
Shimotsuke, Tochigi, 329-0498
Novartis Investigative Site
Shizuoka, Shizuoka, 420-8688
Novartis Investigative Site
Yamagata, Yamagata, 990-0876
Novartis Investigative Site
Yokohama, Kanagawa, 244-0842
Novartis Investigative Site
Yufu, Oita Prefecture, 879-5593
About this study
Official title: A Multicentre, Randomized, Double-blind, Placebo Controlled, Parallel-group Study in Children With Inadequately Controlled Partial Onset Seizures to Investigate Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) as Adjunctive Therapy
This study is designed to provide short term efficacy and safety data of TRI476 in children with inadequately-controlled partial seizures. Patients will be randomized into either drug treatment or placebo group at 1:1 ratio, and receive their respective treatment for 8 weeks. The purpose of study is to confirm that TRI476 as adjunctive therapy is effective and safe.
- Conditions
- Partial Onset Seizures
- Being tested
- TRI476, Placebo to TRI476, Benzodiazepines
- Keywords
- Seizures, oxcarbazepine, child
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRI476Drug
TRI476 oral suspension doses, based on body weight twice daily
Placebo to TRI476Drug
Placebo oral suspension, taken twice daily
BenzodiazepinesDrug
Benzodiazepines could be used as needed as rescue medication during the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| TRI476 | Experimental | Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage. Receives: Drug: TRI476; Drug: Benzodiazepines |
| Placebo | Placebo comparator | Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage. Receives: Drug: Placebo to TRI476; Drug: Benzodiazepines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group
Percent change in partial onset seizure frequency per 28 days during the double-blind phase from the screening phase, was calculated according to the following formula: "Percent change in partial onset seizure frequency per 28 days from the screening phase" = (partial onset seizure frequency per 28 days during the double-blind phase - partial onset seizure frequency per 28 days during the screening phase) / partial onset seizure frequency per 28 days during the double-blind phase x 100 "Partial onset seizure frequency per 28 days" = Number of partial onset seizures during each phase (screening phase or double-blind phase) / number of days during the screening or double-blind phase × 28.
Measured: screening and 28 days
Secondary outcomes (4)
Partial Seizure Frequency Per 28 Days, by Study Period (Every 28 Days) and Treatment Group
Partial onset seizure frequency per 28 days during a period between baseline and Week 4 was measured. Partial onset seizure frequency per 28 days (count/28 days)" = Number of partial onset seizures during each phase (screening phase or double-blind phase) / Number of days during the phase x 28.
Measured: baseline, 28 days and 56 days
Percent of Participants With Response During Double-blind Phase, by Treatment Group
Responder rate was defined as the percent of participants with an at least 50% reduction in partial onset seizure frequency per 28 days from the screening phase.
Measured: screening to 28 days
Percent Change in Partial Onset Seizure Frequency During the Double-blind Phase by Seizure Type
Percent change in seizure frequency from baseline = 100 (T-B)/B, B=Seizure frequency per 28 days during baseline phase, T=Seizure frequency per 28 days during the double-blind phase. Seizure frequency per 28 days is calculated as: (seizure frequency during the double-blind phase / the number of days the seizure information were provided) x 28. Only patients with both baseline and corresponding post-baseline values are included.
Measured: 28 days
Number of Participants With Clinical Global Impression of Change (CGIC) at Final Assessment, by Treatment Group
Clinical Global Impression of Change (CGI) is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-C scores range from 1 (very much improved) through to 7 (very much worse).
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionOct 2012
- Study completionOct 2012
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 Onset SeizuresStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 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
- NCT00975715
- Sponsor's protocol ID
- CTRI476B1301
- Status last verified
- Jul 2014
- First submitted
- 10 Sep 2009
- Last updated
- 16 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Double-blind, Placebo Controlled, Parallel-group Study in Children With Inadequately Controlled Partial Onset Seizures to Investigate Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) as Adjunctive Therapy
- ClinicalTrials.gov ID
- NCT00975715
- Acronym / sponsor ID
- CTRI476B1301
- Conditions
- Partial Onset Seizures
- Keywords
- Seizures, oxcarbazepine, child
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Posted 24 Jan 2014
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 designed to provide short term efficacy and safety data of TRI476 in children with inadequately-controlled partial seizures. Patients will be randomized into either drug treatment or placebo group at 1:1 ratio, and receive their respective treatment for 8 weeks. The purpose of study is to confirm that TRI476 as adjunctive therapy is effective and safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRI476 | Experimental | Drug: TRI476, Drug: BenzodiazepinesParticipants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage. |
| Placebo | Placebo comparator | Drug: Placebo to TRI476, Drug: BenzodiazepinesParticipants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male and female outpatients, aged 4 to 14 years (inclusive), with a minimum body weight of 15 kg.
- A diagnosis of partial onset seizures, which include the seizure subtypes of simple, complex, and secondarily generalized seizures (based on the International League Against Epilepsy (ILAE) Classification, as modified in 1981).
Key exclusion criteria (3 listed)
- A document history of generalized status epileptics in the past 6 months.
- Seizures having a metabolic, neoplastic, or active infectious origin.
- 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 |
|---|---|---|
| TRI476TRI476 oral suspension doses, based on body weight twice daily | Drug | TRI476 |
| Placebo to TRI476Placebo oral suspension, taken twice daily | Drug | Placebo |
| BenzodiazepinesBenzodiazepines could be used as needed as rescue medication during the duration of the study. | Drug | Placebo, TRI476 |
Primary outcome
Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group
Time frame: screening and 28 days
Percent change in partial onset seizure frequency per 28 days during the double-blind phase from the screening phase, was calculated according to the following formula: "Percent change in partial onset seizure frequency per 28 days from the screening phase" = (partial onset seizure frequency per 28 days during the double-blind phase - partial onset seizure frequency per 28 days during the screening phase) / partial onset seizure frequency per 28 days during the double-blind phase x 100 "Partial onset seizure frequency per 28 days" = Number of partial onset seizures during each phase (screening phase or double-blind phase) / number of days during the screening or double-blind phase × 28.
4 secondary outcomes
Partial Seizure Frequency Per 28 Days, by Study Period (Every 28 Days) and Treatment Group
Time frame: baseline, 28 days and 56 days
Percent of Participants With Response During Double-blind Phase, by Treatment Group
Time frame: screening to 28 days
Percent Change in Partial Onset Seizure Frequency During the Double-blind Phase by Seizure Type
Time frame: 28 days
Number of Participants With Clinical Global Impression of Change (CGIC) at Final Assessment, by Treatment Group
Time frame: 56 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about this study:Link provided by the sponsor.
Related trials for Partial Onset Seizures
Enrolling by invitationPhase 2
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Focal Onset Seizures
Active, not recruitingPhase 4
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Focal Onset Seizure
RecruitingPhase 3
A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
Partial Epilepsy
Active, not recruiting
A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
Partial Seizures With Secondary Generalization, Focal Epilepsy With Secondary Generalization
RecruitingPhase 2
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures
Focal Onset Seizures
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
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TRI476 and Benzodiazepines in people with Partial Onset Seizures, run by Novartis Pharmaceuticals at 25 sites in Japan.
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 2 inclusion and 3 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 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Japan. 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 combined 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.
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 24 Jan 2014). 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 Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group (time frame: screening and 28 days). 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 16 Jul 2014.