A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures

• ClinicalTrials.gov Identifier: NCT00280696
• Recruitment Status: Completed
• First Posted: January 23, 2006
• Last Update Posted: February 11, 2015
• Sponsor: UCB Japan Co. Ltd.
• Information provided by (Responsible Party): UCB Pharma ( UCB Japan Co. Ltd. )

Study Description

Brief Summary:

A double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluated the efficacy and safety of levetiracetam used as adjunctive treatment in patients from 16 to 65 years with epilepsy suffering from partial onset seizures.

Condition or disease	Intervention/treatment	Phase
Epilepsies, Partial	Drug: Levetiracetam 250 mg; Drug: Levetiracetam 500 mg; Other: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 352 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Randomized, Placebo-controlled 5 Parallel Groups, Confirmatory Trial on the Efficacy and Safety of Levetiracetam Used as add-on Therapy at Doses of 0.5 to 3 g/Day in Patients From 16 to 65 Years With Epilepsy With Partial Onset Seizures Under Treatment With 1 to 3 Anti-epileptic Drug(s)
• Study Start Date: November 2005
• Actual Primary Completion Date: November 2007
• Actual Study Completion Date: November 2007

Arms and Interventions

Arm	Intervention/treatment
Experimental: Lev 0.5 g; Levetiracetam 0.5 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).	Drug: Levetiracetam 250 mg; Active Substance: Levetiracetam; Pharmaceutical Form: Film-coated tablet; Concentration: 250 mg; Route of Administration: Oral Use; Other Name: Keppra
Experimental: Lev 1 g; Levetiracetam 1 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).	Drug: Levetiracetam 250 mg; Active Substance: Levetiracetam; Pharmaceutical Form: Film-coated tablet; Concentration: 250 mg; Route of Administration: Oral Use; Other Name: Keppra; Drug: Levetiracetam 500 mg; Active Substance: Levetiracetam; Pharmaceutical Form: Film-coated tablet; Concentration: 500 mg; Route of Administration: Oral Use; Other Name: Keppra
Experimental: Lev 2 g; Levetiracetam 2 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).	Drug: Levetiracetam 250 mg; Active Substance: Levetiracetam; Pharmaceutical Form: Film-coated tablet; Concentration: 250 mg; Route of Administration: Oral Use; Other Name: Keppra; Drug: Levetiracetam 500 mg; Active Substance: Levetiracetam; Pharmaceutical Form: Film-coated tablet; Concentration: 500 mg; Route of Administration: Oral Use; Other Name: Keppra
Experimental: Lev 3 g; Levetiracetam 3 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).	Drug: Levetiracetam 250 mg; Active Substance: Levetiracetam; Pharmaceutical Form: Film-coated tablet; Concentration: 250 mg; Route of Administration: Oral Use; Other Name: Keppra; Drug: Levetiracetam 500 mg; Active Substance: Levetiracetam; Pharmaceutical Form: Film-coated tablet; Concentration: 500 mg; Route of Administration: Oral Use; Other Name: Keppra
Placebo Comparator: Placebo; Placebo tablets as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).	Other: Placebo; Active Substance: Placebo; Pharmaceutical Form: Film-coated tablet; Concentration: 250 mg and 500 mg; Route of Administration: Oral Use

Outcome Measures

Primary Outcome Measures :

1. Percent reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period [ Time Frame: From Baseline to the 12-week Evaluation Period ]

Secondary Outcome Measures :

1. Partial (Type I) seizure frequency per week over the Evaluation Period [ Time Frame: 12-week Evaluation Period ]
2. Partial (Type I) seizure responder rates (50 %, 75 %) over the Evaluation Period [ Time Frame: From Baseline to the 12-week Evaluation Period ]
3. Seizure freedom over the Evaluation Period [ Time Frame: 12-week Evaluation Period ]
4. Categorized percentage reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period [ Time Frame: From Baseline to the 12-week Evaluation Period ]
5. Percentage reduction from Baseline in seizure frequency per week by seizure subtype (IA, IB, IC, IA + IB, other) over the Evaluation Period [ Time Frame: From Baseline to the 12-week Evaluation Period ]

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:

Epileptic patients who fulfill the following criteria are eligible for inclusion in the study:

• Subjects aged from 16 to 65 years at the acquisition of informed consent to the trial participation
• Seizure type: subjects with epileptic seizures which were diagnosed as partial seizures more than 2 years ago according to "Clinical and electroencephalographic classification of epileptic seizures (1981)" defined by the International League Against Epilepsy (ILAE) and confirmed with an EEG that has been performed within 1 year before Screening or at the Screening Visit
• Subjects whose previous therapy before screening involved at least two standard anti-epileptic drugs (AEDs) for partial seizures, and in whom it can be confirmed that the doses met the daily dose specified for the treatment of epilepsy in the package insert and that the therapy has been continued for at least 3 months
• Frequency of epileptic seizures: subjects experiencing partial seizures at least 12 times in 12 weeks during the Baseline Period (Week -12 to Week 0) and at least twice in every 4 weeks

Exclusion Criteria:

The following patients are not eligible for inclusion into the study:

• Subjects who were diagnosed with status epilepticus within 3 months before screening
• Subjects with no partial seizures of which frequency was measured during the Baseline Period
• Subjects who underwent surgery for epilepsy within 2 years before Screening or who were scheduled to undergo brain surgery during the study period and within 4 weeks after the completion of this study
• Subjects with a history of oral treatment with Levetiracetam (LEV)

Contacts and Locations

Locations

Japan

Aichi-gun, Aichi, Japan

Nagoya, Aichi, Japan

Nayoga, Aichi, Japan

Hirosaki, Aomori, Japan

Kitakyusyu, Fukuoka, Japan

Kurume, Fukuoka, Japan

Fukuyama, Hiroshima, Japan

Asahikawa, Hokkaido, Japan

Hakodate, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Kobe, Hyogo, Japan

Kahoku-gun, Ishikawa, Japan

Kikuchi-gun, Kumamoto, Japan

Sendai, Miyagi, Japan

Omura, Nagasaki, Japan

Izumi, Osaka, Japan

Neyagawa, Osaka, Japan

Suita, Osaka, Japan

Kawachi-gun, Tochigi, Japan

Kodaira, Tokyo, Japan

Ube, Yamaguchi, Japan

Chiba, Japan

Fukuoka, Japan

Gihu, Japan

Hiroshima, Japan

Kagoshima, Japan

Kobe, Japan

Kyoto, Japan

Miyazaki, Japan

Nagaoka, Japan

Niigata, Japan

Okayama, Japan

Osaka, Japan

Shizuoka, Japan

Tokyo, Japan

Toyama, Japan

Yamagata, Japan

Sponsors and Collaborators

UCB Japan Co. Ltd.

Investigators

• Study Director: UCB Clinical Trial Call Center; UCB Pharma

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Inoue Y, Yagi K, Ikeda A, Sasagawa M, Ishida S, Suzuki A, Yoshida K; Japan Levetiracetam N01221 Study Group. Efficacy and tolerability of levetiracetam as adjunctive therapy in Japanese patients with uncontrolled partial-onset seizures. Psychiatry Clin Neurosci. 2015 Oct;69(10):640-8. doi: 10.1111/pcn.12300. Epub 2015 May 13.

• Responsible Party: UCB Japan Co. Ltd.
• ClinicalTrials.gov Identifier: NCT00280696
• Other Study ID Numbers: N01221; 2014-004333-57 ( EudraCT Number )
• First Posted: January 23, 2006
• Last Update Posted: February 11, 2015
• Last Verified: February 2015

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

Epilepsies, Partial,; Keppra, levetiracetam

Additional relevant MeSH terms:

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