Clinical trial NCT00160615: Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method
Official title: Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy, Partial
Keywords: Epilepsy, partial
Keppra
Levetiracetam
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 154
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Partial (Type I) Seizure Frequency Per Week by Analysis Visit
timeFrame: From Baseline up to 54 months
measure: Partial (Type IA) Seizure Frequency Per Week by Analysis Visit
timeFrame: From Baseline up to 54 months
measure: Partial (Type IB) Seizure Frequency Per Week by Analysis Visit
timeFrame: From Baseline up to 54 months
measure: Partial (Type IC) Seizure Frequency Per Week by Analysis Visit
timeFrame: From Baseline up to 54 months
Secondary outcomes:
measure: Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit
timeFrame: From Baseline up to 54 months
measure: Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit
timeFrame: From Baseline up to 54 months
measure: Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit
timeFrame: From Baseline up to 54 months
measure: Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit
timeFrame: From Baseline up to 54 months
Other outcomes:
Locations:
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: