An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures
This study is currently recruiting participants.
Verified May 2013 by UCB, Inc.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01398956
First received: July 13, 2011
Last updated: May 2, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Levetiracetam
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
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.
| Estimated Enrollment: | 52 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | August 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398956
Contacts
| Contact: UCB Clinical Trial Call Center | +1 877 822 9493 |
Locations
| Japan | |
| 184 | Recruiting |
| Bunkyo, Japan | |
| 152 | Recruiting |
| Fujisawa, Japan | |
| 112 | Recruiting |
| Fukuoka, Japan | |
| 166 | Recruiting |
| Fukuoka, Japan | |
| 113 | Recruiting |
| Fukuoka, Japan | |
| 107 | Recruiting |
| Gifu, Japan | |
| 118 | Recruiting |
| Higashimatsuyama, Japan | |
| 162 | Recruiting |
| Himeji, Japan | |
| 110 | Recruiting |
| Hiroshima, Japan | |
| 143 | Recruiting |
| Kagoshima, Japan | |
| 156 | Recruiting |
| Kagoshima, Japan | |
| 153 | Recruiting |
| Kashiwazaki, Japan | |
| 120 | Recruiting |
| Kodaira, Japan | |
| 105 | Recruiting |
| Kokubunji, Japan | |
| 306 | Recruiting |
| Koshi, Japan | |
| 172 | Recruiting |
| Miyakonojo, Japan | |
| 305 | Recruiting |
| Nagoya, Japan | |
| 190 | Recruiting |
| Nerima, Japan | |
| 106 | Recruiting |
| Niigata, Japan | |
| 109 | Recruiting |
| Okayama, Japan | |
| 130 | Recruiting |
| Otaru, Japan | |
| 119 | Recruiting |
| Saitama, Japan | |
| 147 | Recruiting |
| Sakai, Japan | |
| 304 | Recruiting |
| Sapporo, Japan | |
| 117 | Recruiting |
| Sapporo, Japan | |
| 102 | Recruiting |
| Sendai, Japan | |
| 103 | Recruiting |
| Sendai, Japan | |
| 111 | Recruiting |
| Ube, Japan | |
Sponsors and Collaborators
UCB, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT01398956 History of Changes |
| Other Study ID Numbers: | N01361 |
| Study First Received: | July 13, 2011 |
| Last Updated: | May 2, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by UCB, Inc.:
|
Levetiracetam Epilepsy Generalized tonic-clonic seizures |
Additional relevant MeSH terms:
|
Seizures Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Etiracetam Piracetam |
Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013