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NCT00631150 Clinical Trial

A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

Epilepsy Clinical Trial

Official title:
A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00631150
Other study ID # N01035
Secondary ID
Status Completed
Phase Phase 4
First received February 27, 2008
Last updated November 14, 2013
Start date March 2003
Est. completion date July 2004

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

Clinical Trial Summary

Patients in community-based practices correspond to the 25% of patients who need a first add-on drug when not controlled by their standard monotherapy drug. This was a therapeutic use trial in which the population corresponds more closely to that seen in daily clinical practice.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date July 2004
Est. primary completion date July 2004
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- partial onset seizures with or without secondary generalisation with epilepsy.

Exclusion Criteria:

- hypersensitivity to levetiracetam or other pyrrolidone derivatives or to any of the excipients.

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 (Keppra)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
UCB Pharma

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and the tolerability of Keppra in a broad population of patients.
Secondary Obtain further information about optimal daily dose.
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