Clinical Trial Results:
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
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Summary
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EudraCT number |
2016-002879-96 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
19 Apr 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Oct 2016
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First version publication date |
15 Oct 2016
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
N01361
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01398956 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
UCB Japan Co. Ltd.
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Sponsor organisation address |
8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, Japan, 160-0023
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Public contact |
Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
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Scientific contact |
Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 May 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Apr 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Provide the Levetiracetam (LEV) treatment to epilepsy subjects in Japan who are judged to benefit from continued treatment with LEV by the investigators and who are willing to continuously receive this drug.
Evaluate the safety and tolerability of long-term administration of LEV at doses up to 60 mg/kg/day or 3000 mg/day in epilepsy subjects with generalized tonic-clonic seizures in Japan who have completed the N01159 or N01363 or have discontinued the N01159 due to lack of efficacy.
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Protection of trial subjects |
Not applicable
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Background therapy |
Antiepileptic drug(s) | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
30 Jun 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Japan: 44
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Worldwide total number of subjects |
44
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
6
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Adolescents (12-17 years) |
8
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Adults (18-64 years) |
29
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
This study started to enroll subjects in Japan in June 2011. | ||||||||||||||||
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Pre-assignment
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Screening details |
Participant Flow refers to the Safety Set (SS) which consisted of all subjects who took at least one dose of study medication in this study. | ||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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Levetiracetam | ||||||||||||||||
Arm description |
Levetiracetam dose will be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Keppra
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Investigational medicinal product code |
LEV tablet
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Other name |
Levetiracetam
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Tables in 250 mg and 500 mg concentration
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Investigational medicinal product name |
E Keppra
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Investigational medicinal product code |
LEV syrup
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Other name |
Levetiracetam
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Pharmaceutical forms |
Granules for syrup
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Routes of administration |
Oral use
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Dosage and administration details |
Dry syrup 50%: 0.5 g Levetiracetam content in 1 g dry syrup
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Baseline characteristics reporting groups
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Reporting group title |
Levetiracetam
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Reporting group description |
Levetiracetam dose will be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study | |||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Levetiracetam
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Reporting group description |
Levetiracetam dose will be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study | ||
Subject analysis set title |
Levetiracetam (SS)
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Levetiracetam dose will be adjusted at the investigator’s discretion in the range from
20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
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Subject analysis set title |
Levetiracetam (FAS)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Levetiracetam dose will be adjusted at the investigator’s discretion in the range from
20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
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End point title |
Incidence of treatment emergent adverse events during the entire study period [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Evaluation and Withdrawal Periods
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this endpoint. Results were summarized in tables as descriptive statistics only. |
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| No statistical analyses for this end point | |||||||||
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End point title |
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). | ||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline of feeder study until end of study
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End point title |
The incidence of adverse drug reactions during the entire study period | ||||||||
End point description |
Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug.
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End point type |
Secondary
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End point timeframe |
Evaluation and Withdrawal Periods
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit.
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Adverse event reporting additional description |
Advers events refers to the Safety Set (SS) which consisted of all subjects who took at least one dose of study medication in this study.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.0
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Reporting groups
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Reporting group title |
Levetiracetam (SS)
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Reporting group description |
Levetiracetam dose will be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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28 Feb 2012 |
- Update to the list of restricted concomitant medications; piracetam and pregabalin were added to the list
- Update to the section of rescue medication; fosphenytoin sodium hydrate (injection) was
added to the section
- Administrative changes |
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29 Jan 2013 |
- Update to the section of approval status in Japan and overseas; an approval in Dec 2011 by the Food and Drug Administration (FDA) for LEV as adjunctive treatment in children aged >=1 months was added
- Update to the list of concomitant AEDs; stiripentol was added to the list
- Update to the list of restricted concomitant medications; paliperidone was added to the list
- Administrative changes
- Corrections of typographical errors |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
