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

• ClinicalTrials.gov Identifier: NCT00643500
• Recruitment Status: Completed
• First Posted: March 26, 2008
• Last Update Posted: November 15, 2013
• Sponsor: UCB Pharma
• Information provided by: UCB Pharma

Tracking Information

• First Submitted Date: February 21, 2008
• First Posted Date: March 26, 2008
• Last Update Posted Date: November 15, 2013
• Study Start Date: January 2002
• Actual Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 25, 2008): Adverse event rates, seizure counts and quality of life. [ Time Frame: 16 week treatment period ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epilepsy, Partial
• Intervention: Drug: Levetiracetam
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 25, 2008): 342
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2003
• Actual Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00643500
• Other Study ID Numbers: N01033
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Study Director, UCB
• Study Sponsor: UCB Pharma
• Collaborators: Not Provided

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

• PRS Account: UCB Pharma
• Verification Date: September 2009