A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures
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Purpose
This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in long-term administration in patients who completed N01020 [NCT00160165] or N01221 [NCT00280696].
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsies Partial |
Drug: Levetiracetam |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Open, Long-term Follow-up Study to Evaluate the Safety and Efficacy of L059 (Levetiracetam) at Individual Optimal Dose Ranging From 500 to 3000 mg/Day in Twice Daily Administration in Subjects From 16 to 65 Years With Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized Who Completed in a Previous Study |
- Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted) [ Time Frame: During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) until the time of approval granted ] [ Designated as safety issue: No ]
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product.
Occurrence of treatment-emergent AEs is reported by the number of subjects with at least one treatment-emergent AE.
- Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study [ Time Frame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study ] [ Designated as safety issue: No ]
The change in partial (type 1) seizure frequency from Baseline is given as a percent reduction computed as:
[ Weekly partial seizure frequency (Baseline)- Weekly partial seizure frequency (Evaluation Period)]/ [Weekly partial seizure frequency (Baseline)] x 100.
Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
- Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study [ Time Frame: First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 ( Week 16) ] [ Designated as safety issue: No ]Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
- Response Status (Patients With a Percent Reduction in Partial Seizure Frequency of at Least 50% During the First 16-week Period in This Study From Baseline in N01221) [ Time Frame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study ] [ Designated as safety issue: No ]
The percent reduction from Baseline was computed as:
[ Weekly seizure frequency (Baseline)- Weekly seizure frequency (Evaluation Period)]/ [Weekly seizure frequency (Baseline)] x 100.
Responders are those patients with a percent reduction in partial seizure frequency of at least 50% from Baseline to first Evaluation Period in partial seizure frequency per week.
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
- Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study [ Time Frame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study ] [ Designated as safety issue: No ]
Change in simple partial seizure frequency is given as a percent reduction computed as:
[ Weekly simple partial seizure frequency (Baseline)- Weekly simple partial seizure frequency (Evaluation Period)]/ [Weekly simple partial seizure frequency (Baseline)] x 100.
Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
- Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study [ Time Frame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study ] [ Designated as safety issue: No ]
Change in complex partial seizure frequency is given as a percent reduction computed as:
[ Weekly complex partial seizure frequency (Baseline)- Weekly complex partial seizure frequency (Evaluation Period)]/ [Weekly complex partial seizure frequency (Baseline)] x 100.
Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
- Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study [ Time Frame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study ] [ Designated as safety issue: No ]
Change in secondary generalized seizure frequency is given as a percent reduction computed as:
[ Weekly sec. generalized seizure frequency (Baseline)- Weekly sec. generalized seizure frequency (Evaluation Period)]/ [Weekly sec. generalized seizure frequency (Baseline)] x 100.
Positive values in reduction means the value decreased from Baseline during the first 16-week Period.
Secondary generalized seizures belong to one of the 3 groups:
- Simple partial sz evolving to gen sz
- Complex partial sz evolving to gen sz
- Simple partial sz evolving to Complex partial sz evolving to gen sz
- Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study [ Time Frame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study ] [ Designated as safety issue: No ]
Change in simple and complex partial seizure frequency is given as a percent reduction computed as (simple and complex partial seizure frequency := A):
[ Weekly A (Baseline)- Weekly A (Evaluation Period)]/ [Weekly A (Baseline)] x 100.
Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
- Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study [ Time Frame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study ] [ Designated as safety issue: No ]
Change in other types of seizure frequency is given as a percent reduction computed as (other types of seizure frequency:= B):
[ Weekly B (Baseline)- Weekly B (Evaluation Period)]/ [Weekly B (Baseline)] x 100.
Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.
Other types of Seizures are all seizures except Partial Seizures (Type 1).
| Enrollment: | 398 |
| Study Start Date: | July 2006 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Levetiracetam
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
|
Drug: Levetiracetam
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
Other Name: Keppra
|
Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who participated in study N01221 [NCT00280696] and completed the evaluation period and transition period or patients who participated in study N01020 [NCT00160615]
Exclusion Criteria:
- Female patients during pregnancy, delivery and lactation, or suspected of pregnancy
Contacts and Locations
Show 53 Study Locations| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 |
More Information
Additional Information:
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT00367432 History of Changes |
| Other Study ID Numbers: | N01222 |
| Study First Received: | August 21, 2006 |
| Results First Received: | December 2, 2011 |
| Last Updated: | January 26, 2012 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by UCB, Inc.:
|
Epilepsies Partial Keppra levetiracetam |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Etiracetam Piracetam Anticonvulsants |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013