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Completed

NCT Number: NCT01051193

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

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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Key information

Conditions

Partial Onset Seizures Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

NPC Investigative Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxcarbazepine

Drug

Primary outcomes

  1. Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG))

    Time frame: 52 weeks and until approval/launch

Secondary outcomes

  1. 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

  2. Seizure Frequency of specific duration

    Time frame: 52 weeks and until approval/launch

  3. 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

  4. Percent changes in the seizure frequency by subtype

    Time frame: 52 weeks and until approval/launch

  5. Clinical Global Impression of Change

    Time frame: 52 weeks and until approval/launch

Sponsors and collaborators

Lead sponsor

Nobelpharma

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2010
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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