Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in Subjects With Partial Epilepsy

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630357
• Other study ID #: N01037
• 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: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• 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:

• 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.

Study Design

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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy

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	Investigate seizure freedom with Keppra flexible dose.
Secondary	Tolerability and safety.

External Links

•   Clinical Study Summary on UCB.com