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NCT01051193
Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures
Phase 2, PHASE3 trial testing Oxcarbazepine in Partial Onset Seizures in 88 participants. Completed in 30 September 2019.
30 September 2019
Quick facts
| Lead sponsor | Nobelpharma |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 88 |
| Start date | 5 January 2010 |
| Primary completion | 30 September 2019 |
| Estimated completion | 30 September 2019 |
| Sites | 24 locations across Japan |
Drugs / interventions tested
- Oxcarbazepine — full drug profile →
Conditions studied
- Partial Onset Seizures — all drugs for Partial Onset Seizures →
Sponsor
Nobelpharma — full company profile →
Who can join
Adults 4 to 15, any sex, with Partial Onset Seizures. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01051193
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Oxcarbazepine
Trials testing the same drug.
- NCT06849219 — Comparison of Oxcarbazepine Versus Carbamazepine in the Management of Trigeminal Neuralgia · Phase 4 · active not recruiting
- NCT05697614 — The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children · Phase 4 · unknown
- NCT05450978 — Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding · recruiting
- NCT04996199 — Comparision Efficacy of Carbamazepine & Oxcarbazepine in the Treatment of Trigeminal Neuralgia- a Randomised Clinical Tr · Phase 4 · unknown
- NCT03695094 — A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Pad · Phase 1 · completed
Other Nobelpharma trials
Trials by the same sponsor.
- NCT05480553 — NPC-06 to Pain Associated With Acute Herpes Zoster · Phase 3 · completed
- NCT05495425 — Clinical Study of NPC-12Y Gel in Patients With Skin Lesions Associated With TSC · Phase 3 · completed
- NCT04671472 — Efficacy Confirmation Study of NPC-09 · Phase 3 · completed
- NCT04642950 — A Phase II/III Study of Sargramostim · Phase 2, PHASE3 · completed
- NCT04503863 — An Additional Study of NPC-22 in Healthy Adult Males · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01051193 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nobelpharma
- Last refreshed: 15 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01051193.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing