Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

Epilepsy, Partial Clinical Trial

Official title:

Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160615
• Other study ID #: N01020
• Status: Completed
• Phase: Phase 3
• Start date: September 12, 2001
• Est. completion date: January 17, 2007

Study information

• Verified date: March 2019
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The safety and efficacy of L059 was evaluated in patients who completed "N165 Clinical Trial of L059". They received L059 at a daily dose from 1,000 mg to 3,000 mg in addition to their standard concomitant AEDs

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: January 17, 2007
• Est. primary completion date: January 17, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059

• Patients/the parent or guardian wish to continue treatment with L059 and to enter N165 Follow-up Study, and also the investigator admit the necessity of the repeated intake of the investigational drug for the patients.

Exclusion Criteria:

• Patients who had not participate in N165 Clinical Trial of L059.

• Patients who had participated in N165 Clinical Trial of L059 with no intention of entering the follow-up study taking the same medication.

• Patients had not been in compliance with requirements of Protocol for N165 Clinical Trial of L059 in the course of the study.

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Epilepsy, Partial
• Seizures

Intervention

Drug:
• Levetiracetam
Pharmaceutical form: Film-coating tablets Concentration: 250 mg/ 500 mg Route of administration: oral use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Japan Co. Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partial (Type I) Seizure Frequency Per Week by Analysis Visit	Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.	From Baseline up to 54 months
Primary	Partial (Type IA) Seizure Frequency Per Week by Analysis Visit	Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.	From Baseline up to 54 months
Primary	Partial (Type IB) Seizure Frequency Per Week by Analysis Visit	Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.	From Baseline up to 54 months
Primary	Partial (Type IC) Seizure Frequency Per Week by Analysis Visit	Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.	From Baseline up to 54 months
Secondary	Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit	Percentage change from baseline of of Partial (Type I) seizure frequency over the treatment period standardized to 1 week period.; Negative values indicate improvement from Baseline.	From Baseline up to 54 months
Secondary	Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit	Percentage change from baseline of of Partial (Type IA) seizure frequency over the treatment period standardized to 1 week period.; Negative values indicate improvement from Baseline.	From Baseline up to 54 months
Secondary	Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit	Percentage change from baseline of of Partial (Type IB) seizure frequency over the treatment period standardized to 1 week period.; Negative values indicate improvement from Baseline.	From Baseline up to 54 months
Secondary	Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit	Percentage change from baseline of of Partial (Type IC) seizure frequency over the treatment period standardized to 1 week period.; Negative values indicate improvement from Baseline.	From Baseline up to 54 months

External Links

•   Clinical Study Summary on UCB.com
•   FDA Safety Alerts and Recalls