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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398956
• Other study ID #: N01361
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2011
• Last updated: April 26, 2016
• Start date: June 2011
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Generalized Tonic-clonic Seizures
• Seizures

Intervention

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

Locations

Country	Name	City	State
Japan	152	Fujisawa
Japan	112	Fukuoka
Japan	113	Fukuoka
Japan	165	Fukuoka
Japan	166	Fukuoka
Japan	187	Fukushima
Japan	107	Gifu
Japan	162	Himeji
Japan	110	Hiroshima
Japan	117	Hokkaido
Japan	130	Hokkaido
Japan	176	Hokkaido
Japan	143	Kagoshima
Japan	156	Kagoshima
Japan	120	Kodaira
Japan	105	Kokubunji
Japan	306	Koshi
Japan	172	Miyazaki
Japan	179	Miyazaki
Japan	305	Nagoya
Japan	106	Niigata
Japan	153	Niigata
Japan	109	Okayama
Japan	174	Osaka
Japan	119	Saitama
Japan	147	Sakai
Japan	194	Sakai
Japan	304	Sapporo
Japan	138	Tochigi
Japan	184	Tokyo
Japan	190	Tokyo
Japan	111	Ube

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events during the entire study period.		Evaluation and Withdrawal Periods(up to 3 years)	No
Secondary	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).		Baseline of feeder study until end of study(up to 3 years)	No
Secondary	The incidence of adverse drug reactions during the entire study period	Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug.	Evaluation and Withdrawal Periods(up to 3 years)	No