A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)

Epilepsy Clinical Trial

Official title:

A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Oral Levetiracetam, in Epilepsy Patients Aged ≥16 Years, With Generalized Tonic-clonic (GTC) Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228747
• Other study ID #: N01159
• Secondary ID: 2014-004401-32
• Status: Completed
• Phase: Phase 3
• Start date: October 2010
• Est. completion date: May 2014

Study information

• Verified date: December 2018
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients aged ≥16 years and with uncontrolled Generalized Tonic-Clonic seizures despite treatment with 1 or 2 anti-epileptic drugs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 361
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• An epilepsy patient with generalized tonic-clonic seizures that are classifiable according to the ILAE classification of epileptic seizures (Epilepsia, 1981)

• A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to and during the combined baseline period

Exclusion Criteria:

• Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures

• Diagnosis of Lennox-Gastaut Syndrome

• Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imagining features

• A history of convulsive or non-convulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1

Related Conditions & MeSH terms

• Epilepsy
• Generalized Tonic-Clonic Seizures
• Seizures

Intervention

Drug:
• Levetiracetam
Oral dose at flexible increase doses: 1000 mg/day or 2000 mg/day or 3000 mg/day, twice daily, 28 weeks
• Placebo
Matching oral placebo tablets twice daily for 28 weeks

Locations

Country	Name	City	State
China	1	Beijing
China	9	Beijing
China	12	Changchun
China	19	Chengdu
China	6	Chengdu
China	10	Chongqing
China	16	Guangzhou
China	5	Guangzhou
China	18	Harbin
China	13	Kunming
China	22	Nanjing
China	14	Qingdao
China	2	Shanghai
China	3	Shanghai
China	17	Shenyang
China	15	Taiyuan
China	8	Wuhan
China	7	Xi'an
China	20	Xian
Japan	152	Fujisawa
Japan	112	Fukuoka
Japan	113	Fukuoka
Japan	166	Fukuoka
Japan	187	Fukushima
Japan	124	Hamamatsu
Japan	175	Higashiosaka
Japan	162	Himeji
Japan	110	Hiroshima
Japan	177	Hiroshima
Japan	165	Iizuka
Japan	143	Kagoshima
Japan	156	Kagoshima
Japan	176	Kameda
Japan	150	Kashihara
Japan	153	Kashiwakazi
Japan	105	Kokubunji
Japan	172	Miyakonojo
Japan	179	Miyazaki
Japan	186	Miyazaki
Japan	189	Nagoya
Japan	106	Niigata
Japan	158	Okayama
Japan	157	Osaka
Japan	174	Osaka
Japan	129	Osaka-sayama
Japan	130	Otaru
Japan	170	Saito
Japan	147	Sakai
Japan	194	Sakai
Japan	117	Sapporo
Japan	131	Sapporo
Japan	304	Sapporo
Japan	103	Sendai
Japan	168	Shimajiri
Japan	138	Shimotsuke
Japan	121	Shizuoka
Japan	120	Tokyo
Japan	111	Ube

Sponsors (1)

Lead Sponsor	Collaborator
UCB Japan Co. Ltd.

Countries where clinical trial is conducted

China,  Japan, 

References & Publications (1)

Wu L, Yagi K, Hong Z, Liao W, Wang X, Zhou D, Inoue Y, Ohtsuka Y, Sasagawa M, Terada K, Du X, Muramoto Y, Sano T. Adjunctive levetiracetam in the treatment of Chinese and Japanese adults with generalized tonic-clonic seizures: A double-blind, randomized, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change From the Combined Baseline in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods)	Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Combined Baseline B over the Treatment Period A is calculated using the equation: Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the 28-week treatment Period.; Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline	From Baseline to Week 28
Secondary	The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period	Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from combined baseline B over the Evaluation Period A is calculated using the equation: Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline Information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency.; Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline.	From Baseline to Evaluation Period (Week 12 to Week 28)
Secondary	Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period	A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Treatment Period is considered a GTC 50 % responder.; Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline	From Baseline to Week 28
Secondary	Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Evaluation Period	A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Evaluation Period is considered a GTC 50 % responder.; Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline	From Baseline to Evaluation Period (Week 12 to Week 28)
Secondary	Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period	A subject with a non-missing weekly generalized tonic-clonic (GTC) baseline seizure frequency and a weekly GTC seizure frequency of zero throughout the Evaluation Period, is considered as a GTC seizure-free subject on the Evaluation Period.	Evaluation Period (Week 12 to Week 28)

External Links

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