An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506882
• Other study ID #: N01375
• Secondary ID: 2014-004377-16
• Status: Completed
• Phase: Phase 3
• First received: January 5, 2012
• Last updated: November 24, 2015
• Start date: December 2011
• Est. completion date: April 2015

Study information

• Verified date: November 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: April 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Partial Onset Seizures
• Seizures

Intervention

Drug:
• Levetiracetam (LEV)
Active Substance: Levetiracetam Pharmaceutical Form: Film-coated tablet Concentration: LEV 250 mg, LEV 500 mg Frequency: Twice daily Route of Administration: Oral use

Locations

Country	Name	City	State
Japan	19	Aomori
Japan	33	Asaka
Japan	21	Daito
Japan	12	Fujisawa
Japan	14	Hamamatsu
Japan	11	Himeji
Japan	30	Hirosaki
Japan	8	Kagoshima
Japan	20	Kamakura
Japan	17	Kawasaki
Japan	3	Kitakyusyu
Japan	26	Kodaira
Japan	9	Kokubunji
Japan	32	Kyoto
Japan	25	Miyakonojo
Japan	5	Nagoya Aichi
Japan	4	Nara
Japan	22	Okayama
Japan	15	Osaka
Japan	27	Osaka
Japan	24	Osakasayama
Japan	13	Saitama
Japan	1	Sakai
Japan	29	Sapporo
Japan	2	Toyonaka
Japan	7	Ube
Japan	18	Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
UCB Japan Co. Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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: A documented seizure during 6 consecutive months of the Evaluation Analysis Period; Subject discontinued the study prematurely during the Evaluation Analysis Period; Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.	From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period	No
Secondary	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	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	No
Secondary	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	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: A documented seizure during 6 consecutive months of the Evaluation Analysis Period; Subject discontinued the study prematurely during the Evaluation Analysis Period; Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.	From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period	No
Secondary	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	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	No
Secondary	Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group	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	No
Secondary	Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group	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	No
Secondary	Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group	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	No
Secondary	Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group	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	No

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