- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01506882
An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy
An Open-label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Levetiracetam Used as Monotherapy in Newly or Recently Diagnosed Epilepsy Patients Aged Older Than or Equal to 16 Years With Partial Seizures
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Aomori, Japan
- 19
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Asaka, Japan
- 33
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Daito, Japan
- 21
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Fujisawa, Japan
- 12
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Hamamatsu, Japan
- 14
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Himeji, Japan
- 11
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Hirosaki, Japan
- 30
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Kagoshima, Japan
- 8
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Kamakura, Japan
- 20
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Kawasaki, Japan
- 17
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Kitakyusyu, Japan
- 3
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Kodaira, Japan
- 26
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Kokubunji, Japan
- 9
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Kyoto, Japan
- 32
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Miyakonojo, Japan
- 25
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Nagoya Aichi, Japan
- 5
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Nara, Japan
- 4
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Okayama, Japan
- 22
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Osaka, Japan
- 15
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Osaka, Japan
- 27
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Osakasayama, Japan
- 24
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Saitama, Japan
- 13
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Sakai, Japan
- 1
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Sapporo, Japan
- 29
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Toyonaka, Japan
- 2
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Ube, Japan
- 7
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Yamagata, Japan
- 18
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject is male or female and aged ≥ 16 years at Visit 1
- Subjects with newly or recently diagnosed Epilepsy having experienced unprovoked Partial Seizures (IA, IB, IC), that are classifiable according to the International League Against Epilepsy (ILAE) classification of Epileptic Seizures
- Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year prior to Visit 1, of which, at least 1 unprovoked seizure occurred in the 3 months prior to Visit 1
- Minimum body weight of 40 kg at Visit 1
Exclusion Criteria:
- Subject has a history or presence of seizure types other than partial (IA, IB, IC)
- Subject has an experience of any type of brain surgery in the consecutive 2 years prior to Visit 1
- Subject has a history or presence of known Pseudo-Seizures
- Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) within the 6 months prior to Visit 1. However, acute and sub-acute seizure treatments are accepted for a maximum use of 2 weeks, if the treatments are stopped for the week prior to Visit 1
- Subject has a known clinically significant acute or chronic illness, such as but not restricted to: cardiac, renal, hepatic dysfunction, endocrinological, or psychiatric illness, and that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Levetiracetam 1000 mg/day to 2000 mg/day group
Subjects in the LEV 1000 mg/day to 2000 mg/day group receive the initial dose of LEV 1000 mg/day for the 1- week Stabilization Period and enter the Evaluation Period. Unless a seizure occurs during the Evaluation Period, the subjects will continue LEV 1000 mg/day for 26 weeks. If a seizure occurs during the Evaluation Period, the dose will be increased to 2000 mg/day and a restart of stabilization on LEV 2000 mg/day for 1 week is required prior to restarting the 26-weeks Evaluation Period on LEV 2000 mg/day. The LEV dose could be decreased as a fallback option at the investigator's discretion, if the subject did not tolerate the LEV dosage, as evidenced by the development of an AE. The fallback option was permitted to be performed once for subjects on LEV 2000 mg/day at any time during the restarted Stabilization Period (SP), restarted Evaluation Period (EP), or Maintenance Period (MP), as well as for subjects on LEV 3000 mg/day at any time during the SP, EP, or MP. |
Other Names:
|
Experimental: Levetiracetam 3000 mg/day group
Unless a seizure occurs, the subjects in this arm will continue LEV 3000 mg/day for 26 weeks. Subjects in the LEV 3000 mg/day group undergo a 4-week Up-Titration Period prior to the 1-week Stabilization Period. They receive 1000 mg/day for 2 weeks and 2000 mg/day for 2 weeks during the Up-Titration Period and LEV 3000 mg/day for 1 week during the Stabilization Period. The LEV dose could be decreased as a fallback option at the investigator's discretion, if the subject did not tolerate the LEV dosage, as evidenced by the development of an AE. The fallback option was permitted to be performed once for subjects on LEV 2000 mg/day at any time during the restarted Stabilization Period (SP), restarted Evaluation Period (EP), or Maintenance Period (MP), as well as for subjects on LEV 3000 mg/day at any time during the SP, EP, or MP. |
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period
Time Frame: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period
|
A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
|
From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period
Time Frame: From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period
|
Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving the same dose of LEV as in the Evaluation Period during the 26-weeks Maintenance Period unless a seizure occurs.
|
From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period
|
Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period
Time Frame: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period
|
A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
|
From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period
|
Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period
Time Frame: From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period
|
Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving LEV 3000 mg/day during the 26-weeks Maintenance Period unless a seizure occurs.
|
From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period
|
Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group
Time Frame: During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year
|
Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered. The Median time to first seizure will be estimated from the Kaplan-Meier curve. |
During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year
|
Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group
Time Frame: During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year
|
Median time to withdrawal will be estimated from the Kaplan-Meier curve.
|
During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year
|
Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group
Time Frame: During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year
|
Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered. The Median time to first seizure will be estimated from the Kaplan-Meier curve. |
During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year
|
Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group
Time Frame: During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year
|
Median time to withdrawal will be estimated from the Kaplan-Meier curve.
|
During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N01375
- 2014-004377-16 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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