Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy

NCT ID: NCT00643500

Last Updated: 2013-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 342 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2003-05-31

Brief Summary

Patients with partial-onset seizures seen in community-based practices were to be included in this therapeutic use study

• to assess the safety and tolerability of Keppra (Levetiracetam) and to confirm the favorable safety of the drug found during clinical development
• to obtain further information about optimal dosing in daily clinical practice. Compared to previous registration trials, the study population corresponded more closely to that seen in daily clinical practice.

Conditions

Epilepsy, Partial

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Levetiracetam

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female older than 16 years;
• Epilepsy with partial onset seizures, with or without secondary generalization;
• At least one concomitant marketed anti-epileptic drug

Exclusion Criteria

• Safety reasons

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

UCB

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Other Identifiers

N01033

Identifier Type: -

Identifier Source: org_study_id