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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRI476 | Experimental | TRI476 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxcarbazepine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG)) | 52 weeks and until approval/launch |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in the partial seizure frequency per 28 days during the double-blind period from the screening period | 52 weeks and until approval/launch | |
| Seizure Frequency of specific duration | 52 weeks and until approval/launch |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NPC Investigative Site | Nagoya | Aichi-ken | 460-0004 | Japan | ||
| NPC Investigative Site |
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
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| Responder rate: defined as the proportion of patients with an at least 50% reduction in the partial epileptic seizure frequency | 52 weeks and until approval/launch |
| Percent changes in the seizure frequency by subtype | 52 weeks and until approval/launch |
| Clinical Global Impression of Change | 52 weeks and until approval/launch |
| Ōbu |
| Aichi-ken |
| 474-8710 |
| Japan |
| NPC Investigative Site | Matsuyama | Ehime | 790-8524 | Japan |
| NPC Investigative Site | Fukuoka | Fukuoka | 814-0180 | Japan |
| NPC Investigative Site | Kameda-gun | Hokkaido | 041-1111 | Japan |
| NPC Investigative Site | Sapporo | Hokkaido | 060-8648 | Japan |
| NPC Investigative Site | Himeji | Hyōgo | 670-8540 | Japan |
| NPC Investigative Site | Kobe | Hyōgo | 658-0032 | Japan |
| NPC Investigative Site | Yokohama | Kanagawa | 244-0842 | Japan |
| NPC Investigative Site | Kōshi | Kumamoto | 861-1196 | Japan |
| NPC Investigative Site | Kashiwazaki | Niigata | 945-8585 | Japan |
| NPC Investigative Site | Yufu | Oita Prefecture | 879-5593 | Japan |
| NPC Investigative Site | Kurashiki | Okayama-ken | 710-8522 | Japan |
| NPC Investigative Site | Okayama | Okayama-ken | 700-8558 | Japan |
| NPC Investigative Site | Neyagawa | Osaka | 572-0085 | Japan |
| NPC Investigative Site | Saitama | Saitama | 330-8777 | Japan |
| NPC Investigative Site | Moriyama-shi | Shiga | 524-0022 | Japan |
| NPC Investigative Site | Shizuoka | Shizuoka | 420-8688 | Japan |
| NPC Investigative Site | Shimotsuke | Tochigi | 329-0498 | Japan |
| NPC Investigative Site | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| NPC Investigative Site | Gifu | 502-8558 | Japan |
| NPC Investigative Site | Niigata | 950-2085 | Japan |
| NPC Investigative Site | Saitama | 355-0008 | Japan |
| NPC Investigative Site | Yamagata | 990-0876 | Japan |
| ID | Term |
|---|---|
| D012640 | Seizures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078330 | Oxcarbazepine |
| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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