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OpenTrials
Completed

NCT Number: NCT00630357

Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in Subjects With Partial Epilepsy

A cohort of patients who became seizure-free during add-on treatment to one standard AED with Keppra in a previous trial (N01031) were followed to assess whether seizure freedom was maintained. Tolerability was documented.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of epilepsy with partial seizures;
  • having completed the trial N01031 of Keppra as adjunctive therapy (SKATE);
  • seizure-free over the last 3 months prior to protocol Visit 1;
  • 1 concomitant marketed AED at the time of trial entry and throughout the previous trial N01031;
  • on the clinical judgment of the Investigator, progressive withdrawal of the concomitant AED and conversion to monotherapy with Keppra can be attempted.

Exclusion criteria

  • History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous 5 years;
  • presence of known pseudoseizures within the last year;
  • presence or history of allergy to the components of Keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives;
  • felbamate with less than 18 months exposure;
  • vigabatrin, without visual field assessment as per recommendation of the manufacturer, i.e., every 6 months;
  • uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.

Treatment and study plan

Levetiracetam (Keppra)

Drug

Primary outcomes

  1. Investigate seizure freedom with Keppra flexible dose.

Secondary outcomes

  1. Tolerability and safety.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Phase IV, Open-label, Multi-center Trial to Evaluate the Safety and Efficacy of Keppra® After Conversion to Mono-therapy in Adult Subjects With Partial Epilepsy

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Mar 7, 2008
Registry last updated
Nov 15, 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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