Phase 3
N=44
An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures
Epilepsy · Generalized Tonic-clonic Seizures
Bottom Line
View on ClinicalTrials.gov: NCT01398956 ↗Enrolled (actual)
44
Serious AEs
29.5%
Results posted
Mar 2017
Primary outcome: Primary: Incidence of Treatment Emergent Adverse Events During the Entire Study Period — 626 Treatment Emergent Adverse Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Levetiracetam (Drug)
- Age
- Pediatric, Adult, Older Adult · 4+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment Emergent Adverse Events During the Entire Study Period |
626 | — |
| SECONDARY The Percentage Change 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). |
-92.07 | — |
| SECONDARY The Incidence of Adverse Drug Reactions During the Entire Study Period |
46 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01398956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.