Trial Outcomes & Findings for An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures (NCT NCT01398956)
NCT ID: NCT01398956
Last Updated: 2017-08-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
44 participants
Primary outcome timeframe
Through study completion, an average of 3 years
Results posted on
2017-08-15
Participant Flow
This study started to enroll subjects in Japan in June 2011.
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.
Participant milestones
| Measure |
Levetiracetam
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 Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Levetiracetam
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 Study
Withdrawal by Subject
|
4
|
|
Overall Study
AE, non-serious non-fatal
|
4
|
|
Overall Study
Withdrawal Criteria No.3
|
1
|
|
Overall Study
Subject moved a long distance
|
1
|
Baseline Characteristics
An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures
Baseline characteristics by cohort
| Measure |
Levetiracetam
n=44 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 Years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
26.1 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 3 yearsPopulation: The Safety Set (SS) consisted of all subjects who took at least one dose of study medication in this study.
Outcome measures
| Measure |
Levetiracetam (SS)
n=44 Participants
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
|
|---|---|
|
Incidence of Treatment Emergent Adverse Events During the Entire Study Period
|
626 Treatment Emergent Adverse Events
|
SECONDARY outcome
Timeframe: During the Treatment Period (up to 4.8 years)Population: 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).
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.
Outcome measures
| Measure |
Levetiracetam (SS)
n=43 Participants
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
|
|---|---|
|
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 percent change
Interval -97.16 to -64.64
|
SECONDARY outcome
Timeframe: Through study completion, an average of 3 yearsPopulation: The Safety Set (SS) consisted of all subjects who took at least one dose of study medication in this study.
Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug.
Outcome measures
| Measure |
Levetiracetam (SS)
n=44 Participants
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
|
|---|---|
|
The Incidence of Adverse Drug Reactions During the Entire Study Period
|
46 Adverse Drug Reactions
|
Adverse Events
Levetiracetam (SS)
Serious events: 13 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Levetiracetam (SS)
n=44 participants at risk
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
|
|---|---|
|
Infections and infestations
Influenza
|
4.5%
2/44 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Infections and infestations
Acute tonsillitis
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Infections and infestations
Bronchitis
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Infections and infestations
Bronchopneumonia
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Infections and infestations
Pharyngotonsillitis
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Infections and infestations
Postoperative wound infection
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Investigations
Medical observation
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Musculoskeletal and connective tissue disorders
Fracture malunion
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
2.3%
1/44 • Number of events 7 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast adenoma
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Nervous system disorders
Convulsion
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Nervous system disorders
Epilepsy
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Nervous system disorders
Monoplegia
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Reproductive system and breast disorders
Prostatitis
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
2.3%
1/44 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Surgical and medical procedures
Abortion induced
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Surgical and medical procedures
Scoliosis surgery
|
2.3%
1/44 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
Other adverse events
| Measure |
Levetiracetam (SS)
n=44 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Dental caries
|
25.0%
11/44 • Number of events 13 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.2%
8/44 • Number of events 14 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Gastrointestinal disorders
Constipation
|
15.9%
7/44 • Number of events 8 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Gastrointestinal disorders
Vomiting
|
11.4%
5/44 • Number of events 7 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
4/44 • Number of events 5 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
General disorders
Pyrexia
|
18.2%
8/44 • Number of events 14 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Infections and infestations
Nasopharyngitis
|
79.5%
35/44 • Number of events 138 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Infections and infestations
Influenza
|
20.5%
9/44 • Number of events 12 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Infections and infestations
Otitis media
|
13.6%
6/44 • Number of events 6 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Infections and infestations
Gastroenteritis
|
11.4%
5/44 • Number of events 11 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Infections and infestations
Bronchitis
|
6.8%
3/44 • Number of events 5 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Infections and infestations
Conjunctivitis
|
6.8%
3/44 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Infections and infestations
Pulpitis dental
|
6.8%
3/44 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
15.9%
7/44 • Number of events 16 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Injury, poisoning and procedural complications
Excoriation
|
13.6%
6/44 • Number of events 32 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Injury, poisoning and procedural complications
Wound
|
9.1%
4/44 • Number of events 4 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Investigations
Weight increased
|
11.4%
5/44 • Number of events 6 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Investigations
Electrocardiogram QT prolonged
|
6.8%
3/44 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Investigations
Protein urine present
|
6.8%
3/44 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
4/44 • Number of events 6 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
3/44 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Nervous system disorders
Convulsion
|
36.4%
16/44 • Number of events 40 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Nervous system disorders
Somnolence
|
22.7%
10/44 • Number of events 10 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Nervous system disorders
Headache
|
20.5%
9/44 • Number of events 21 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Nervous system disorders
Dizziness
|
6.8%
3/44 • Number of events 4 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.8%
3/44 • Number of events 4 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.8%
3/44 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
11.4%
5/44 • Number of events 6 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
9.1%
4/44 • Number of events 12 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).
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.
|
Additional Information
UCB (Study Director)
UCB Cares
Phone: +1887822
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60