Clinical trial NCT01506882: An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Partial Onset Seizures
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2012-01-10
Enrollment: 71
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period
Secondary outcomes:
measure: 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
timeFrame: From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period
measure: 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
timeFrame: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period
measure: 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
timeFrame: From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period
measure: Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group
timeFrame: During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year
measure: Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group
timeFrame: During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year
measure: Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group
timeFrame: During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year
measure: Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group
timeFrame: During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year
Other outcomes:
Locations:
city: Aomori
country: Japan
facility: 19
city: Asaka
country: Japan
facility: 33
city: Daito
country: Japan
facility: 21
city: Fujisawa
country: Japan
facility: 12
city: Hamamatsu
country: Japan
facility: 14
city: Himeji
country: Japan
facility: 11
city: Hirosaki
country: Japan
facility: 30
city: Kagoshima
country: Japan
facility: 8
city: Kamakura
country: Japan
facility: 20
city: Kawasaki
country: Japan
facility: 17
city: Kitakyusyu
country: Japan
facility: 3
city: Kodaira
country: Japan
facility: 26
city: Kokubunji
country: Japan
facility: 9
city: Kyoto
country: Japan
facility: 32
city: Miyakonojo
country: Japan
facility: 25
city: Nagoya Aichi
country: Japan
facility: 5
city: Nara
country: Japan
facility: 4
city: Okayama
country: Japan
facility: 22
city: Osakasayama
country: Japan
facility: 24
city: Osaka
country: Japan
facility: 15
city: Osaka
country: Japan
facility: 27
city: Saitama
country: Japan
facility: 13
city: Sakai
country: Japan
facility: 1
city: Sapporo
country: Japan
facility: 29
city: Toyonaka
country: Japan
facility: 2
city: Ube
country: Japan
facility: 7
city: Yamagata
country: Japan
facility: 18
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: