Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-Therapy in Subjects With Partial Epilepsy - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00630357

Purpose

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 IV

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Infectious Mononucleosis Seizures

Drug Information available for: Levetiracetam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by UCB:

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)

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630357

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	N01037
Study First Received:	February 27, 2008
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00630357
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by UCB:

Levetiracetam
Keppra

Study placed in the following topic categories:

Epilepsies, Partial
Epilepsy
Infectious Mononucleosis
Piracetam

Central Nervous System Diseases
Etiracetam
Brain Diseases

Additional relevant MeSH terms:

Nootropic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Protective Agents

Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 15, 2009