DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy; Partial Onset Seizures

Intervention: Levetiracetam (LEV) (Drug); Levetiracetam (LEV) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: UCB Japan Co. Ltd.

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)

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.

Clinical Details

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

Primary outcome: 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

Secondary outcome:

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

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

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 to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group

Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group

Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group

Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

24, Osakasayama, Japan

15, Osaka, Japan

27, Osaka, Japan

13, Saitama, Japan

1, Sakai, Japan

29, Sapporo, Japan

2, Toyonaka, Japan

7, Ube, Japan

18, Yamagata, Japan

Additional Information

Product Information

FDA Safety Alerts and Recalls

Starting date: December 2011
Last updated: May 4, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017