A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures

• ClinicalTrials.gov Identifier: NCT00367432
• Recruitment Status: Completed
• First Posted: August 22, 2006
• Results First Posted: January 16, 2012
• Last Update Posted: November 13, 2020
• Sponsor: UCB Japan Co. Ltd.
• Information provided by (Responsible Party): UCB Pharma ( UCB Japan Co. Ltd. )

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Epilepsies; Partial	Drug: Levetiracetam	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 398 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: July 2006
• Actual Primary Completion Date: December 2010
• Actual Study Completion Date: December 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

   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.

Secondary Outcome Measures :

1. 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 ]

   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.

2. 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) ]
   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.
3. 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 ]

   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.

4. 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 ]

   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.

5. 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 ]

   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.

6. 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 ]

   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
7. 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 ]

   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.

8. 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 ]

   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).

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Locations

Japan

Aichi-gun, Aichi, Japan

Nagoya, Aichi, Japan

Hirosaki, Aomori, Japan

Matsudo, Chiba, Japan

Kitakyusyu, Fukuoka, Japan

Koga, Fukuoka, Japan

Kurume, Fukuoka, Japan

Fukuyama, Hiroshima, Japan

Asahikawa, Hokkaido, Japan

Hakodate, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Kobe, Hyogo, Japan

Kahoku-gun, Ishikawa, Japan

Kanazawa, Ishikawa, Japan

Zentsuji, Kagawa, Japan

Koshi, Kumamoto, Japan

Tsu, Mie, Japan

Iwanuma, Miyagi, Japan

Sendai, Miyagi, Japan

Omura, Nagasaki, Japan

Kashihara, Nara, Japan

Nagaoka, Niigata, Japan

Beppu, Oita, Japan

Izumi, Osaka, Japan

Neyagawa, Osaka, Japan

Suita, Osaka, Japan

Takatsuki, Osaka, Japan

Iruma-gun, Saitama, Japan

Shimotsuga-gun, Tochigi, Japan

Shimotsuke, Tochigi, Japan

Komatsushima, Tokushima, Japan

Chiyoda-Ku, Tokyo, Japan

Kodaira, Tokyo, Japan

Kokubunji, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Taito-ku, Tokyo, Japan

Ube, Yamaguchi, Japan

Aomori, Japan

Chiba, Japan

Fukuoka, Japan

Fukushima, Japan

Gifu, Japan

Hiroshima, Japan

Kagoshima, Japan

Kumamoto, Japan

Kyoto, Japan

Miyazaki, Japan

Niigata, Japan

Okayama, Japan

Osaka, Japan

Shizuoka, Japan

Toyama, Japan

Yamagata, Japan

Sponsors and Collaborators

UCB Japan Co. Ltd.

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493

More Information

Additional Information:

FDA Safety Alerts and Recalls 

• Responsible Party: UCB Japan Co. Ltd.
• ClinicalTrials.gov Identifier: NCT00367432
• Other Study ID Numbers: N01222; 2014-004334-26 ( EudraCT Number )
• First Posted: August 22, 2006
• Results First Posted: January 16, 2012
• Last Update Posted: November 13, 2020
• Last Verified: April 2015

Keywords provided by UCB Pharma ( UCB Japan Co. Ltd. ):

Epilepsies; Partial; Keppra; levetiracetam

Additional relevant MeSH terms:

Epilepsy; Seizures; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Levetiracetam; Anticonvulsants; Nootropic Agents