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An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01398956
First received: July 13, 2011
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are judged to benefit from continued treatment with Levetiracetam by the investigators and who are willing to continuously receive this drug.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Long-term, Follow-up Study in Japan to Evaluate the Safety, Tolerability, and Efficacy of Adjunctive Treatment With Oral L059 (Levetiracetam) in Epilepsy Subjects With Generalized Tonic-clonic (GTC) Seizures

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Incidence of treatment emergent adverse events during the entire study period. [ Time Frame: Evaluation and Withdrawal Periods(up to 3 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percentage reduction in Generalized Tonic-Clonic (GTC) seizure frequency per week over the Evaluation Period from either of the Combined Baseline Periods of the previous studies (N01159 or N01363). [ Time Frame: Baseline of feeder study until end of study(up to 3 years) ] [ Designated as safety issue: No ]
  • The incidence of adverse drug reactions during the entire study period [ Time Frame: Evaluation and Withdrawal Periods(up to 3 years) ] [ Designated as safety issue: No ]
    Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug.


Enrollment: 44
Study Start Date: June 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levetiracetam
Twice daily (morning and evening) orally
Drug: Levetiracetam

formulation: tablet or dry syrup

strength: 250 mg tablet, 500 mg tablet, dry syrup 50%

dosage: Sb ≥16 years and ≥4 and <16 years (≥50 kg): 1000 mg/day, 2000 mg/day or 3000 mg/day; Sb ≥4 and <16 years (<50kg): 20 mg/kg/day, 40 mg/kg/day, or 60 mg/kg/day

frequency: twice daily

Other Name: Keppra, E Keppra

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject in Japan has completed either of the studies N01159 or N01363 or has discontinued the N01159 study due to lack of efficacy.
  • The subject who is judged to benefit from continued treatment with Levetiracetam by the investigators

Exclusion Criteria:

  • Subjects with multiple protocol deviations during N01159 or N01363, such as missing laboratory data, and low or noncompliance with the study medication, and who the investigator considers not to have the potential to have deviations stopped are ineligible
  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: NCT01398956

Locations
Japan
184
Bunkyo, Japan
152
Fujisawa, Japan
112
Fukuoka, Japan
113
Fukuoka, Japan
166
Fukuoka, Japan
187
Fukushima, Japan
107
Gifu, Japan
162
Himeji, Japan
110
Hiroshima, Japan
165
Iizuka, Japan
156
Kagoshima, Japan
143
Kagoshima, Japan
176
Kameda-Gun, Japan
153
Kashiwazaki, Japan
120
Kodaira, Japan
105
Kokubunji, Japan
306
Koshi, Japan
172
Miyakonojo, Japan
179
Miyazaki, Japan
305
Nagoya, Japan
190
Nerima, Japan
106
Niigata, Japan
109
Okayama, Japan
174
Osaka, Japan
130
Otaru, Japan
119
Saitama, Japan
147
Sakai, Japan
194
Sakai, Japan
117
Sapporo, Japan
304
Sapporo, Japan
138
Shimotsuke, Japan
111
Ube, Japan
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01398956     History of Changes
Other Study ID Numbers: N01361
Study First Received: July 13, 2011
Last Updated: November 13, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by UCB Pharma:
Levetiracetam
Epilepsy
Generalized tonic-clonic seizures

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 November 20, 2014