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

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ClinicalTrials.gov Identifier: NCT00630357
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : November 15, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Epilepsy Drug: Levetiracetam (Keppra) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2003
Primary Completion Date : July 2004
Study Completion Date : July 2004


Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. Tolerability and safety.

Eligibility Criteria

Information from the National Library of Medicine

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

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630357


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

Additional Information:
Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00630357     History of Changes
Other Study ID Numbers: N01037
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: September 2009

Keywords provided by UCB Pharma:
Levetiracetam
Keppra

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs