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NCT01051193 Clinical Trial

Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures

Partial Onset Seizures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01051193
Other study ID # CTRI476B1301E1
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date January 5, 2010
Est. completion date September 30, 2019

Study information
Verified date November 2019
Source Nobelpharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date September 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers No
Gender All
Age group 4 Years to 15 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oxcarbazepine

Locations
Country Name City State
Japan NPC Investigative Site Bunkyo-ku Tokyo
Japan NPC Investigative Site Fukuoka-city Fukuoka
Japan NPC Investigative Site Gifu
Japan NPC Investigative Site Himeji Hyogo
Japan NPC Investigative Site Kameda-gun Hokkaido
Japan NPC Investigative Site Kashiwazaki Niigata
Japan NPC Investigative Site Kobe Hyogo
Japan NPC Investigative Site Koshi-city Kumamoto
Japan NPC Investigative Site Kurashiki Okayama
Japan NPC Investigative Site Matsuyama-city Ehime
Japan NPC Investigative Site Moriyama-shi Shiga
Japan NPC Investigative Site Nagoya-shi Aichi
Japan NPC Investigative Site Neyagawa Osaka
Japan NPC Investigative Site Niigata
Japan NPC Investigative Site Obu-city Aichi
Japan NPC Investigative Site Okayama-city Okayama
Japan NPC Investigative Site Saitama
Japan NPC Investigative Site Saitama-city Saitama
Japan NPC Investigative Site Sapporo-city Hokkaido
Japan NPC Investigative Site Shimotsuke-city Tochigi
Japan NPC Investigative Site Shizuoka-city Shizuoka
Japan NPC Investigative Site Yamagata
Japan NPC Investigative Site Yokohama Kanagawa
Japan NPC Investigative Site Yufu Oita

Sponsors (1)
Lead Sponsor Collaborator
Nobelpharma

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG)) 52 weeks and until approval/launch
Secondary 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
Secondary Seizure Frequency of specific duration 52 weeks and until approval/launch
Secondary 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
Secondary Percent changes in the seizure frequency by subtype 52 weeks and until approval/launch
Secondary Clinical Global Impression of Change 52 weeks and until approval/launch
See also
  Status Clinical Trial Phase
Completed NCT01710657 - A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures Phase 3
Completed NCT00975715 - Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures Phase 2/Phase 3
Completed NCT02072824 - A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures. Phase 3
Completed NCT01830868 - A Post-marketing Observational Study Of The Use Of Zonisamide (ZNS) in the Adjunctive Treatment Of Adult Patients With Partial Onset Seizures (Study E2090-E044-410) (ZOOM)
Completed NCT03201900 - Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Participants With Partial Onset Seizures (Including Secondarily Generalized Seizures (FREEDOM Study) Phase 3
Completed NCT01338805 - Phase II BGG492 Capsule Extension for Partial Epilepsy Phase 2
Completed NCT01147003 - Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures Phase 2
Completed NCT01407523 - An Open Label Study of L059 Intravenous (IV) in Japanese Epilepsy Subjects With Partial Onset Seizures Phase 2
Completed NCT04252846 - A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy
Completed NCT03836924 - A Study to Assess Safety and Efficacy of Perampanel in Indian Participants as an Adjunctive Treatment in Partial Onset Seizures With or Without Secondary Generalized Seizures in Participants With Epilepsy Aged 12 Years or Older
Completed NCT01506882 - An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy Phase 3
Completed NCT03288129 - Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures Phase 4
Withdrawn NCT01167335 - Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures Phase 2
Completed NCT01830400 - A Post-marketing Study Evaluating Eslicarbazepine Acetate (ESL) as Adjunctive Treatment in Partial-Onset Seizures (Study E2093-E044-404) (EPOS) N/A
Completed NCT00655486 - Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures Phase 3
Completed NCT00655551 - Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures Phase 3
No longer available NCT01871233 - An Extended Access Program for Perampanel