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

This study has been completed.
Information provided by:
UCB Pharma Identifier:
First received: February 27, 2008
Last updated: November 14, 2013
Last verified: September 2009
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.

Condition Intervention Phase
Epilepsy Drug: Levetiracetam (Keppra) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Investigate seizure freedom with Keppra flexible dose.

Secondary Outcome Measures:
  • Tolerability and safety.

Enrollment: 14
Study Start Date: March 2003
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00630357

Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Responsible Party: Study Director, UCB Identifier: NCT00630357     History of Changes
Other Study ID Numbers: N01037
Study First Received: February 27, 2008
Last Updated: November 14, 2013

Keywords provided by UCB Pharma:

Additional relevant MeSH terms:
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs processed this record on June 23, 2017