Partial Onset SeizuresPhase 2/3NCT01051193
Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures
A Phase 2/3 study testing Oxcarbazepine in people with Partial Onset Seizures, run by Nobelpharma at 24 sites in Japan.
Trial summary
This study is designed to provide long term safety data of TRI476 in children with inadequately-controlled partial seizures. This study is conducted in patients who complete the core study CTRI476B1301. Blinding is maintained during the transition and dose adjustment phase of the extension study. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Partial Onset Seizures
- What is being tested?
- Oxcarbazepine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 24 sitesJapan
- Study dates
- 5 Jan 2010to 30 Sep 2019
- Phase
- Phase 2/3
- 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 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients who completed the double-blind treatment phase of the core study (B1301).
- A parent/legal guardian must be present and give written consent for all patients enrolled in this trial. Patients consent must be obtained using assent document according to patients age.
- Females of childbearing potential must have a negative pregnancy test at Week 8 in the core study B1301.
Who cannot join
- Patients with medical ineligibility to enter the extension, as assessed by the investigator at each site.
- Patients who participated in the core study, but did not complete it (prematurely discontinued)
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Japan24 sites
NPC Investigative Site
Bunkyo-ku, Tokyo, 113-8431
NPC Investigative Site
Fukuoka, Fukuoka, 814-0180
NPC Investigative Site
Gifu, 502-8558
NPC Investigative Site
Himeji, Hyōgo, 670-8540
NPC Investigative Site
Kameda-gun, Hokkaido, 041-1111
NPC Investigative Site
Kashiwazaki, Niigata, 945-8585
NPC Investigative Site
Kobe, Hyōgo, 658-0032
NPC Investigative Site
Kōshi, Kumamoto, 861-1196
NPC Investigative Site
Kurashiki, Okayama-ken, 710-8522
NPC Investigative Site
Matsuyama, Ehime, 790-8524
NPC Investigative Site
Moriyama-shi, Shiga, 524-0022
NPC Investigative Site
Nagoya, Aichi-ken, 460-0004
NPC Investigative Site
Neyagawa, Osaka, 572-0085
NPC Investigative Site
Niigata, 950-2085
NPC Investigative Site
Ōbu, Aichi-ken, 474-8710
NPC Investigative Site
Okayama, Okayama-ken, 700-8558
NPC Investigative Site
Saitama, Saitama, 330-8777
NPC Investigative Site
Saitama, 355-0008
NPC Investigative Site
Sapporo, Hokkaido, 060-8648
NPC Investigative Site
Shimotsuke, Tochigi, 329-0498
NPC Investigative Site
Shizuoka, Shizuoka, 420-8688
NPC Investigative Site
Yamagata, 990-0876
NPC Investigative Site
Yokohama, Kanagawa, 244-0842
NPC Investigative Site
Yufu, Oita Prefecture, 879-5593
About this study
Official title: A Multicentre, Open-label, Extension Study in Children With Inadequately Controlled Partial Onset Seizures to Investigate Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) as Adjunctive Therapy
This study is designed to provide long term safety data of TRI476 in children with inadequately-controlled partial seizures. This study is conducted in patients who complete the core study CTRI476B1301. Blinding is maintained during the transition and dose adjustment phase of the extension study. All patients are treated with TRI476 from the dose adjustment phase onwards. The purpose of study is to confirm that TRI476 as adjunctive therapy is safe.
- Conditions
- Partial Onset Seizures
- Being tested
- Oxcarbazepine
- 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.
OxcarbazepineDrug
| Study group | Role | What they receive |
|---|---|---|
| TRI476 | Experimental | TRI476 Receives: Drug: Oxcarbazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG))
Measured: 52 weeks and until approval/launch
Secondary outcomes (5)
Percent change in the partial seizure frequency per 28 days during the double-blind period from the screening period
Measured: 52 weeks and until approval/launch
Seizure Frequency of specific duration
Measured: 52 weeks and until approval/launch
Responder rate: defined as the proportion of patients with an at least 50% reduction in the partial epileptic seizure frequency
Measured: 52 weeks and until approval/launch
Percent changes in the seizure frequency by subtype
Measured: 52 weeks and until approval/launch
Clinical Global Impression of Change
Measured: 52 weeks and until approval/launch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study start5 Jan 2010
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Onset 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobelpharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051193
- Sponsor's protocol ID
- CTRI476B1301E1
- Status last verified
- Nov 2019
- First submitted
- 15 Jan 2010
- Last updated
- 15 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NPC is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-label, Extension Study in Children With Inadequately Controlled Partial Onset Seizures to Investigate Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) as Adjunctive Therapy
- ClinicalTrials.gov ID
- NCT01051193
- Acronym / sponsor ID
- CTRI476B1301E1
- Conditions
- Partial Onset Seizures
- Keywords
- Seizures, oxcarbazepine, child
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2010 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 18 Jan 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.
This study is designed to provide long term safety data of TRI476 in children with inadequately-controlled partial seizures. This study is conducted in patients who complete the core study CTRI476B1301. Blinding is maintained during the transition and dose adjustment phase of the extension study. All patients are treated with TRI476 from the dose adjustment phase onwards. The purpose of study is to confirm that TRI476 as adjunctive therapy is safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRI476 | Experimental | Drug: OxcarbazepineTRI476 |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients who completed the double-blind treatment phase of the core study (B1301).
- A parent/legal guardian must be present and give written consent for all patients enrolled in this trial. Patients consent must be obtained using assent document according to patients age.
- Females of childbearing potential must have a negative pregnancy test at Week 8 in the core study B1301.
Key exclusion criteria (3 listed)
- Patients with medical ineligibility to enter the extension, as assessed by the investigator at each site.
- Patients who participated in the core study, but did not complete it (prematurely discontinued)
- 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 | TRI476 |
Primary outcome
Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG))
Time frame: 52 weeks and until approval/launch
5 secondary outcomes
Percent change in the partial seizure frequency per 28 days during the double-blind period from the screening period
Time frame: 52 weeks and until approval/launch
Seizure Frequency of specific duration
Time frame: 52 weeks and until approval/launch
Responder rate: defined as the proportion of patients with an at least 50% reduction in the partial epileptic seizure frequency
Time frame: 52 weeks and until approval/launch
Percent changes in the seizure frequency by subtype
Time frame: 52 weeks and until approval/launch
Clinical Global Impression of Change
Time frame: 52 weeks and until approval/launch
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 15 Nov 2019.
- Individual participant dataSharing planned: Undecided. NPC is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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.
The record lists no contact. Use the official record to reach the sponsor.
24 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 Oxcarbazepine in people with Partial Onset Seizures, run by Nobelpharma at 24 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 3 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 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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. 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?
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 (adverse events, laboratory tests, vital signs, electrocardiogram (ECG)) (time frame: 52 weeks and until approval/launch). 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 15 Nov 2019.