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OpenTrials
Completed

NCT Number: NCT00600509

Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method

Double-blind, randomized, placebo-controlled, multi center trial to evaluate the efficacy and safety of levetiracetam as adjunctive treatment in adult Japanese epileptic subjects with partial onset seizures.

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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • simple and/or complex partial seizures with or without secondary generalization, and first partial seizure >= 2 years before selection visit;
  • seizures classifiable according to the ILAE classification;
  • minimum of 12 partial seizures per 12 weeks with a minimum of two partial seizures per 4 weeks from the selection visit to the end of the baseline period ;
  • exposed to two or more standard AEDs;
  • taking up to three of the standard AEDs, at the initiation of the trial.

Exclusion criteria

  • medication influencing the CNS, except for medication taken for antiepileptic treatment;
  • partial seizures uncountable due to clustering, including status epileptics, during the 3 months prior to the selection visit;
  • history of cerebrovascular disease including transient ischemic attack (TIA) and progressive cerebral disorder or progressive neurological disorder;
  • presence or history of any clinically significant allergic condition and complication or history of significant alcohol abuse or drug abuse in the past.

Treatment and study plan

Levetiracetam

Drug

Primary outcomes

  1. partial onset seizure frequency per week

    Time frame: collection of seizure count throughout the whole study (baseline and treatment periods)

Secondary outcomes

  1. safety and tolerability

    Time frame: safety and tolerability data were collected throughout the study period

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Collaborators

  • UCB Japan Co. Ltd.

Registry information

Official study title

Bridging Study of L059(Levetiracetam) in Patients With Epilepsy by Double Blind Method

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Jan 25, 2008
Registry last updated
Sep 17, 2013

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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