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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier:
NCT01228747
First received: October 22, 2010
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Epilepsy
Generalized Tonic-Clonic Seizures
Drug: Levetiracetam
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Seizures

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Percentage reduction from the Combined Baseline (a 4-week Retrospective Baseline + 4-week Prospective Baseline) in the generalized tonic-clonic seizure frequency per week over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods) [ Time Frame: From Basline to Week 28 ] [ Designated as safety issue: No ]
    Percentage reduction from the Combined Baseline (a 4-week Retrospective Baseline + 4-week Prospective Baseline) in the generalized tonic-clonic seizure frequency per week over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods)


Secondary Outcome Measures:
  • The percentage reduction in generalized tonic-clonic seizure frequency per week from the combined baseline over the evaluation period [ Time Frame: From Baseline to Evaluation Period (Week 16 to Week 28) ] [ Designated as safety issue: No ]
    The percentage reduction in generalized tonic-clonic seizure frequency per week from the combined baseline over the evaluation period

  • 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 [ Time Frame: From Baseline to Week 28 ] [ Designated as safety issue: No ]
    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

  • 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 [ Time Frame: From Baseline to Evaluation Period (Week 16 to Week 28) ] [ Designated as safety issue: No ]
    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

  • Generalized tonic-clonic seizure freedom over the evaluation period [ Time Frame: Evaluation Period (Week 16 to Week 28) ] [ Designated as safety issue: No ]
    Generalized tonic-clonic seizure freedom over the evaluation period


Enrollment: 361
Study Start Date: October 2010
Study Completion Date: May 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo for 28 weeks
Drug: Placebo
Matching oral placebo tablets twice daily for 28 weeks
Experimental: Levetiracetam
Levetiracetam treatment with flexible dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks
Drug: Levetiracetam
Oral dose at flexible increase doses: 1000 mg/day or 2000 mg/day or 3000 mg/day, twice daily, 28 weeks
Other Name: Keppra®

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228747

  Hide Study Locations
Locations
China
9
Beijing, China
1
Beijing, China
12
Changchun, China
6
Chengdu, China
19
Chengdu, China
10
Chongqing, China
16
Guangzhou, China
5
Guangzhou, China
18
Harbin, China
13
Kunming, China
22
Nanjing, China
14
Qingdao, China
3
Shanghai, China
2
Shanghai, China
17
Shenyang, China
15
Taiyuan, China
8
Wuhan, China
7
Xi'an, China
20
Xian, China
Japan
152
Fujisawa, Japan
113
Fukuoka, Japan
166
Fukuoka, Japan
112
Fukuoka, Japan
187
Fukushima, Japan
124
Hamamatsu, Japan
175
Higashiosaka, Japan
162
Himeji, Japan
110
Hiroshima, Japan
177
Hiroshima, Japan
165
Iizuka, Japan
156
Kagoshima, Japan
143
Kagoshima, Japan
176
Kameda, Japan
150
Kashihara, Japan
153
Kashiwakazi, Japan
105
Kokubunji, Japan
172
Miyakonojo, Japan
186
Miyazaki, Japan
179
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
194
Sakai, Japan
147
Sakai, Japan
131
Sapporo, Japan
117
Sapporo, Japan
304
Sapporo, Japan
103
Sendai, Japan
168
Shimajiri, Japan
138
Shimotsuke, Japan
121
Shizuoka, Japan
120
Tokyo, Japan
111
Ube, Japan
Sponsors and Collaborators
UCB Japan Co. Ltd.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier: NCT01228747     History of Changes
Other Study ID Numbers: N01159
Study First Received: October 22, 2010
Last Updated: June 30, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
China: Food and Drug Administration

Keywords provided by UCB Pharma:
Levetiracetam
epilepsy
generalized tonic-clonic

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014