Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00975715
First received: September 10, 2009
Last updated: July 31, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Partial Onset Seizures |
Drug: Oxcarbazepine Drug: Placebo Comparator |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics:
Seizures
Drug Information available for:
Oxcarbazepine
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Percent change in the partial seizure frequency per 28 days during the double-blind period from the screening period. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Seizure Frequency of specific duration [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Responder rate: defined as the proportion of patients with an at least 50% reduction in the partial epileptic seizure frequency. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Percent changes in the seizure frequency by subtype [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Clinical Global Impression of Change (CGIC) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Safety and tolerability(Adverse events, Laboratory tests, Vital signs, Electrocardiogram (ECG) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TRI476
TRI476
|
Drug: Oxcarbazepine |
|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo Comparator |
Eligibility| Ages Eligible for Study: | 4 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975715
Locations
| Japan | |
| Novartis Investigative Site | |
| Bunkyo, Japan | |
| Novartis Investigative Site | |
| Fukuoka, Japan | |
| Novartis Investigative Site | |
| Kobe, Japan | |
| Novartis Investigational Site | |
| Neyagawa, Japan | |
| Novartis Investigative Site | |
| Okayama, Japan | |
| Novartis Investigative Site | |
| Yokohama, Japan | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00975715 History of Changes |
| Other Study ID Numbers: | CTRI476B1301 |
| Study First Received: | September 10, 2009 |
| Last Updated: | July 31, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Novartis:
|
Seizures oxcarbazepine child |
Additional relevant MeSH terms:
|
Seizures Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Oxcarbazepine Carbamazepine Anticonvulsants Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 19, 2013