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

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ClinicalTrials.gov Identifier: NCT01398956
Recruitment Status : Completed
First Posted : July 21, 2011
Results First Posted : March 9, 2017
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Epilepsy
Generalized Tonic-clonic Seizures
Intervention Drug: Levetiracetam
Enrollment 44
Recruitment Details This study started to enroll subjects in Japan in June 2011.
Pre-assignment 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.
Arm/Group Title Levetiracetam
Hide Arm/Group Description Levetiracetam dose was 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
Period Title: Overall Study
Started 44
Completed 34
Not Completed 10
Reason Not Completed
Withdrawal by Subject             4
AE, non-serious non-fatal             4
Withdrawal Criteria No.3             1
Subject moved a long distance             1
Arm/Group Title Levetiracetam
Hide Arm/Group Description Levetiracetam dose was 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
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
The Baseline Characteristics refer to the Safety Set (SS) which consisted of all subjects who took at least one dose of study medication in this study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
<=18 years
15
  34.1%
Between 18 and 65 Years
28
  63.6%
>=65 years
1
   2.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants
26.1  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
16
  36.4%
Male
28
  63.6%
1.Primary Outcome
Title Incidence of Treatment Emergent Adverse Events During the Entire Study Period
Hide Description [Not Specified]
Time Frame Through study completion, an average of 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all subjects who took at least one dose of study medication in this study.
Arm/Group Title Levetiracetam (SS)
Hide Arm/Group Description:
Levetiracetam dose was 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
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: Treatment Emergent Adverse Events
626
2.Secondary Outcome
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).
Hide Description

Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Baseline of previous studies B over the Treatment Period A is calculated using the equation:

Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing/unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the Treatment Period.

Time Frame During the Treatment Period (up to 4.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all subjects with evaluable baseline and post-baseline values of generalized tonic-clonic (GTC) seizure frequency as the efficacy analysis, excluding those patients who seriously violated Good Clinical Practice (GCP).
Arm/Group Title Levetiracetam (FAS)
Hide Arm/Group Description:
Levetiracetam dose was 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
Overall Number of Participants Analyzed 43
Median (95% Confidence Interval)
Unit of Measure: percent change
-92.07
(-97.16 to -64.64)
3.Secondary Outcome
Title The Incidence of Adverse Drug Reactions During the Entire Study Period
Hide Description Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug.
Time Frame Through study completion, an average of 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all subjects who took at least one dose of study medication in this study.
Arm/Group Title Levetiracetam (SS)
Hide Arm/Group Description:
Levetiracetam dose was 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
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: Adverse Drug Reactions
46
Time Frame Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
Adverse Event Reporting 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.
 
Arm/Group Title Levetiracetam (SS)
Hide Arm/Group Description Levetiracetam dose was 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
All-Cause Mortality
Levetiracetam (SS)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levetiracetam (SS)
Affected / at Risk (%) # Events
Total   13/44 (29.55%)    
Infections and infestations   
Influenza * 1  2/44 (4.55%)  2
Acute tonsillitis * 1  1/44 (2.27%)  1
Bronchitis * 1  1/44 (2.27%)  1
Bronchopneumonia * 1  1/44 (2.27%)  1
Pharyngotonsillitis * 1  1/44 (2.27%)  1
Pneumonia respiratory syncytial viral * 1  1/44 (2.27%)  1
Postoperative wound infection * 1  1/44 (2.27%)  1
Injury, poisoning and procedural complications   
Cervical vertebral fracture * 1  1/44 (2.27%)  1
Femoral neck fracture * 1  1/44 (2.27%)  1
Investigations   
Medical observation * 1  1/44 (2.27%)  1
Musculoskeletal and connective tissue disorders   
Fracture malunion * 1  1/44 (2.27%)  1
Torticollis * 1  1/44 (2.27%)  7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast adenoma * 1  1/44 (2.27%)  1
Nervous system disorders   
Convulsion * 1  1/44 (2.27%)  1
Epilepsy * 1  1/44 (2.27%)  1
Monoplegia * 1  1/44 (2.27%)  1
Reproductive system and breast disorders   
Prostatitis * 1  1/44 (2.27%)  1
Respiratory, thoracic and mediastinal disorders   
Sleep apnoea syndrome * 1  1/44 (2.27%)  1
Status asthmaticus * 1  1/44 (2.27%)  2
Surgical and medical procedures   
Abortion induced * 1  1/44 (2.27%)  1
Scoliosis surgery * 1  1/44 (2.27%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Levetiracetam (SS)
Affected / at Risk (%) # Events
Total   41/44 (93.18%)    
Gastrointestinal disorders   
Dental caries * 1  11/44 (25.00%)  13
Diarrhoea * 1  8/44 (18.18%)  14
Constipation * 1  7/44 (15.91%)  8
Vomiting * 1  5/44 (11.36%)  7
Nausea * 1  4/44 (9.09%)  5
General disorders   
Pyrexia * 1  8/44 (18.18%)  14
Infections and infestations   
Nasopharyngitis * 1  35/44 (79.55%)  138
Influenza * 1  9/44 (20.45%)  12
Otitis media * 1  6/44 (13.64%)  6
Gastroenteritis * 1  5/44 (11.36%)  11
Bronchitis * 1  3/44 (6.82%)  5
Conjunctivitis * 1  3/44 (6.82%)  3
Pulpitis dental * 1  3/44 (6.82%)  3
Injury, poisoning and procedural complications   
Contusion * 1  7/44 (15.91%)  16
Excoriation * 1  6/44 (13.64%)  32
Wound * 1  4/44 (9.09%)  4
Investigations   
Weight increased * 1  5/44 (11.36%)  6
Electrocardiogram QT prolonged * 1  3/44 (6.82%)  3
Protein urine present * 1  3/44 (6.82%)  3
Musculoskeletal and connective tissue disorders   
Pain in extremity * 1  4/44 (9.09%)  6
Arthralgia * 1  3/44 (6.82%)  3
Nervous system disorders   
Convulsion * 1  16/44 (36.36%)  40
Somnolence * 1  10/44 (22.73%)  10
Headache * 1  9/44 (20.45%)  21
Dizziness * 1  3/44 (6.82%)  4
Respiratory, thoracic and mediastinal disorders   
Cough * 1  3/44 (6.82%)  4
Rhinitis allergic * 1  3/44 (6.82%)  3
Skin and subcutaneous tissue disorders   
Eczema * 1  5/44 (11.36%)  6
Skin erosion * 1  4/44 (9.09%)  12
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB (Study Director)
Organization: UCB Cares
Phone: +1887822 ext 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01398956     History of Changes
Other Study ID Numbers: N01361
First Submitted: July 13, 2011
First Posted: July 21, 2011
Results First Submitted: September 29, 2016
Results First Posted: March 9, 2017
Last Update Posted: August 15, 2017