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NCT00643500 Clinical Trial

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

Epilepsy, Partial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00643500
Other study ID # N01033
Secondary ID
Status Completed
Phase Phase 4
First received February 21, 2008
Last updated November 14, 2013
Start date January 2002
Est. completion date May 2003

Study information
Verified date September 2009
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 342
Est. completion date May 2003
Est. primary completion date May 2003
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Levetiracetam

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
UCB Pharma

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse event rates, seizure counts and quality of life. 16 week treatment period
See also
  Status Clinical Trial Phase
Completed NCT00105040 - A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures Phase 2
Completed NCT00160615 - Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method Phase 3
Completed NCT00113165 - Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures Phase 3
Completed NCT00175890 - A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures. Phase 3
Completed NCT00152516 - Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures Phase 3
Withdrawn NCT01691872 - Pharmacokinetic Study of Retigabine Extended Release (XR) Formulation in Healthy Adult Japanese and Caucasian Subjects Phase 1
Completed NCT00160654 - Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy Phase 4
Terminated NCT01545518 - IVIG Treatment for Refractory Immune-Related Adult Epilepsy Phase 2
Completed NCT00141414 - To Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy. Phase 2
Completed NCT01332539 - An Observational Study to Assess the Burden of Drug-resistant Partial Epilepsy in Italy N/A
Completed NCT00355082 - Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy Phase 3
Completed NCT00152451 - Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures Phase 2
Withdrawn NCT02220972 - To Evaluate the Effect of Perampanel on Objective and Subjective Sleep in Subjects With Insomnia and Partial Onset Seizures Phase 4
Completed NCT00160628 - Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy Phase 3
Completed NCT00245713 - Determine Effects of Adjunctive Levetiracetam on Sleep Architecture in Adults With Partial Onset Epilepsy. Phase 4
Terminated NCT01375374 - Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide Phase 3
Completed NCT00152373 - Double-blind, Placebo-controlled Study of Levetiracetam in Adults With POS Phase 3
Completed NCT00150709 - A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy Phase 3
Completed NCT00152503 - Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam Phase 2
Terminated NCT01891890 - Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE) Phase 3

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