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Trial record 1 of 1 for:    NCT00160615
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Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00160615
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy, Partial
Intervention Drug: Levetiracetam
Enrollment 154
Recruitment Details The study started to enroll patients in September 2001 and concluded in January 2007.
Pre-assignment Details Participant Flow refers to the Full Analysis Set (FAS). Of the 154 subjects who enrolled in the study, 151 subjects were included in the FAS population and 3 subjects were identified with major protocol deviations leading to exclusion from FAS.
Arm/Group Title N165 Randomized Treatment PBO N165 Randomized Treatment LEV
Hide Arm/Group Description Subjects received Placebo (PBO) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day. Subjects received Levetiracetam (LEV) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Period Title: Overall Study
Started 50 101
Completed 32 56
Not Completed 18 45
Reason Not Completed
Adverse Event             5             12
Withdrawal by Subject             0             2
Lack of Efficacy             11             23
Patient decision             1             2
Investigator decision             1             1
AE agents had to be discontinued (exam.)             0             1
Switch to surgical treatment             0             2
Non-compliance was suspected             0             1
Poor compliance             0             1
Arm/Group Title N165 Randomized Treatment PBO (FAS) N165 Randomized Treatment LEV (FAS) Total Title
Hide Arm/Group Description Subjects received Placebo (PBO) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day. Subjects received Levetiracetam (LEV) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day. [Not Specified]
Overall Number of Baseline Participants 50 101 151
Hide Baseline Analysis Population Description
Full analysis Set (FAS)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 101 participants 151 participants
33.19  (9.99) 31.95  (10.19) 32.36  (10.11)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 50 participants 101 participants 151 participants
<=18 years 2 6 8
Between 18 and 65 years 48 95 143
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 101 participants 151 participants
Female
27
  54.0%
47
  46.5%
74
  49.0%
Male
23
  46.0%
54
  53.5%
77
  51.0%
1.Primary Outcome
Title Partial (Type I) Seizure Frequency Per Week by Analysis Visit
Hide Description Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.
Time Frame From Baseline up to 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set included 151 subjects. Only subjects with valid data for partial (Type I) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.
Arm/Group Title N165 Randomized Treatment PBO N165 Randomized Treatment LEV
Hide Arm/Group Description:
Subjects received Placebo (PBO) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Subjects received Levetiracetam (LEV) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Overall Number of Participants Analyzed 50 101
Median (Inter-Quartile Range)
Unit of Measure: Number of Seizures (Type I) per week
>= 1 day(d) - <= 3 months(m) Number Analyzed 50 participants 100 participants
1.68
(1.18 to 4.06)
2.19
(0.99 to 5.41)
> 3 m - <= 6 m Number Analyzed 43 participants 92 participants
1.69
(1.00 to 2.75)
2.00
(0.87 to 4.48)
> 6 m - <= 9 m Number Analyzed 40 participants 82 participants
1.58
(0.88 to 2.69)
1.78
(0.68 to 4.94)
> 9 m - <= 12 m Number Analyzed 39 participants 78 participants
1.41
(0.95 to 3.25)
1.60
(0.60 to 5.05)
> 12 m - <= 15 m Number Analyzed 35 participants 68 participants
1.58
(1.06 to 2.50)
1.55
(0.80 to 4.67)
> 15 m - <= 18 m Number Analyzed 32 participants 64 participants
1.36
(1.03 to 2.32)
1.69
(0.75 to 4.80)
> 18 m - <= 21 m Number Analyzed 30 participants 61 participants
1.35
(0.72 to 1.96)
1.51
(0.62 to 4.49)
> 21 m - <= 24 m Number Analyzed 30 participants 59 participants
1.30
(0.75 to 1.98)
1.36
(0.67 to 3.17)
> 24 m - <= 27 m Number Analyzed 30 participants 56 participants
1.25
(0.56 to 2.38)
1.33
(0.82 to 2.80)
> 27 m - <= 30 m Number Analyzed 30 participants 55 participants
1.30
(0.66 to 2.46)
1.28
(0.72 to 2.75)
> 30 m - <= 33 m Number Analyzed 29 participants 52 participants
1.21
(0.71 to 2.65)
1.33
(0.77 to 2.83)
> 33 m - <= 36 m Number Analyzed 29 participants 49 participants
1.14
(0.68 to 2.69)
1.30
(0.71 to 3.31)
> 36 m - <= 39 m Number Analyzed 28 participants 49 participants
1.20
(0.65 to 2.92)
1.28
(0.75 to 3.32)
> 39 m - <= 42 m Number Analyzed 27 participants 43 participants
1.25
(0.50 to 2.91)
1.32
(0.58 to 2.62)
> 42 m - <= 45 m Number Analyzed 20 participants 30 participants
1.17
(0.79 to 2.41)
1.28
(0.60 to 2.49)
> 45 m - <= 48 m Number Analyzed 16 participants 23 participants
0.95
(0.54 to 2.05)
1.09
(0.25 to 1.58)
> 48 m - <= 51 m Number Analyzed 12 participants 17 participants
0.90
(0.31 to 1.61)
0.70
(0.14 to 1.42)
> 51 m - <= 54 m Number Analyzed 10 participants 12 participants
1.06
(0.08 to 2.17)
0.78
(0.11 to 1.33)
> 54 m Number Analyzed 8 participants 5 participants
1.16
(0.27 to 1.65)
0.09
(0.08 to 1.16)
2.Primary Outcome
Title Partial (Type IA) Seizure Frequency Per Week by Analysis Visit
Hide Description Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.
Time Frame From Baseline up to 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with Type IA seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IA) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.
Arm/Group Title N165 Randomized Treatment PBO N165 Randomized Treatment LEV
Hide Arm/Group Description:
Subjects received Placebo (PBO) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Subjects received Levetiracetam (LEV) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Overall Number of Participants Analyzed 23 61
Median (Inter-Quartile Range)
Unit of Measure: Number of Seizures (Type IA) per week
>= 1 d - <= 3 m Number Analyzed 23 participants 60 participants
0.86
(0.07 to 1.73)
0.68
(0.06 to 4.41)
> 3 m - <= 6 m Number Analyzed 20 participants 58 participants
0.32
(0.06 to 1.44)
0.83
(0.06 to 3.31)
> 6 m - <= 9 m Number Analyzed 18 participants 53 participants
0.24
(0.00 to 1.33)
0.63
(0.05 to 4.67)
> 9 m - <= 12 m Number Analyzed 18 participants 51 participants
0.26
(0.00 to 1.23)
0.50
(0.00 to 3.47)
> 12 m - <= 15 m Number Analyzed 16 participants 44 participants
0.57
(0.09 to 1.35)
0.22
(0.00 to 2.74)
> 15 m - <= 18 m Number Analyzed 15 participants 43 participants
0.27
(0.00 to 1.32)
0.30
(0.00 to 2.81)
> 18 m - <= 21 m Number Analyzed 13 participants 41 participants
0.10
(0.00 to 1.38)
0.42
(0.00 to 1.82)
> 21 m - <= 24 m Number Analyzed 13 participants 39 participants
0.17
(0.06 to 1.00)
0.43
(0.05 to 1.60)
> 24 m - <= 27 m Number Analyzed 13 participants 36 participants
0.29
(0.00 to 1.10)
0.25
(0.00 to 1.41)
> 27 m - <= 30 m Number Analyzed 13 participants 34 participants
0.44
(0.00 to 1.06)
0.17
(0.00 to 1.41)
> 30 m - <= 33 m Number Analyzed 13 participants 33 participants
0.24
(0.00 to 0.98)
0.25
(0.08 to 1.32)
> 33 m - <= 36 m Number Analyzed 13 participants 31 participants
0.17
(0.00 to 0.83)
0.29
(0.05 to 1.63)
> 36 m - <= 39 m Number Analyzed 13 participants 31 participants
0.14
(0.00 to 0.40)
0.13
(0.04 to 1.50)
> 39 m - <= 42 m Number Analyzed 12 participants 28 participants
0.17
(0.00 to 0.83)
0.28
(0.04 to 1.29)
> 42 m - <= 45 m Number Analyzed 11 participants 20 participants
0.09
(0.00 to 1.13)
0.44
(0.08 to 1.03)
> 45 m - <= 48 m Number Analyzed 8 participants 16 participants
0.20
(0.08 to 0.97)
0.48
(0.09 to 1.38)
> 48 m - <= 51 m Number Analyzed 6 participants 11 participants
0.44
(0.00 to 1.42)
0.18
(0.00 to 1.17)
> 51 m - <= 54 m Number Analyzed 5 participants 9 participants
0.62
(0.00 to 1.59)
0.17
(0.10 to 0.63)
> 54 m Number Analyzed 4 participants 5 participants
0.87
(0.14 to 1.65)
0.08
(0.00 to 0.84)
3.Primary Outcome
Title Partial (Type IB) Seizure Frequency Per Week by Analysis Visit
Hide Description Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.
Time Frame From Baseline up to 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with Type IB seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IB) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.
Arm/Group Title N165 Randomized Treatment PBO N165 Randomized Treatment LEV
Hide Arm/Group Description:
Subjects received Placebo (PBO) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Subjects received Levetiracetam (LEV) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Overall Number of Participants Analyzed 44 91
Median (Inter-Quartile Range)
Unit of Measure: Number of Seizures (Type IB) per week
>= 1 d - <= 3 m Number Analyzed 43 participants 91 participants
1.56
(0.94 to 2.49)
1.27
(0.50 to 3.25)
> 3 m - <= 6 m Number Analyzed 37 participants 83 participants
1.51
(0.81 to 2.69)
1.13
(0.38 to 3.18)
> 6 m <= 9 m Number Analyzed 34 participants 74 participants
1.30
(0.60 to 2.25)
0.92
(0.25 to 2.31)
> 9 m - <= 12 m Number Analyzed 33 participants 71 participants
1.39
(0.80 to 1.88)
0.72
(0.24 to 2.11)
> 12 m - <= 15 m Number Analyzed 30 participants 62 participants
1.34
(0.71 to 1.94)
0.81
(0.38 to 2.12)
> 15 m - <= 18 m Number Analyzed 27 participants 58 participants
1.25
(0.81 to 2.21)
0.81
(0.35 to 1.88)
> 18 m - <= 21 m Number Analyzed 25 participants 56 participants
1.25
(0.72 to 1.95)
0.58
(0.31 to 2.34)
> 21 m - <= 24 m Number Analyzed 25 participants 54 participants
1.26
(0.70 to 1.90)
0.73
(0.26 to 2.65)
> 24 m - <= 27 m Number Analyzed 25 participants 52 participants
1.21
(0.56 to 2.50)
0.85
(0.13 to 2.05)
> 27 m - <= 30 m Number Analyzed 25 participants 52 participants
1.21
(0.66 to 3.33)
0.98
(0.15 to 1.74)
> 30 m - <= 33 m Number Analyzed 24 participants 50 participants
1.25
(0.69 to 2.84)
0.79
(0.20 to 2.04)
> 33 m - <= 36 m Number Analyzed 24 participants 47 participants
1.15
(0.76 to 2.91)
0.96
(0.14 to 2.13)
> 36 m - <= 39 m Number Analyzed 23 participants 47 participants
1.28
(0.80 to 3.43)
1.04
(0.17 to 2.48)
> 39 m - <= 42 m Number Analyzed 22 participants 42 participants
1.40
(0.66 to 3.48)
0.77
(0.13 to 1.71)
> 42 m - <= 45 m Number Analyzed 16 participants 29 participants
1.22
(0.76 to 2.79)
0.89
(0.08 to 1.52)
> 45 m - <= 48 m Number Analyzed 12 participants 22 participants
0.87
(0.46 to 2.89)
0.27
(0.00 to 1.36)
> 48 m - <= 51 m Number Analyzed 8 participants 16 participants
0.74
(0.33 to 2.46)
0.22
(0.02 to 1.15)
> 51 m - <= 54 m Number Analyzed 6 participants 12 participants
0.80
(0.46 to 3.64)
0.19
(0.00 to 1.25)
> 54 m Number Analyzed 5 participants 5 participants
0.72
(0.54 to 1.33)
0.09
(0.00 to 0.17)
4.Primary Outcome
Title Partial (Type IC) Seizure Frequency Per Week by Analysis Visit
Hide Description Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.
Time Frame From Baseline up to 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with Type IC seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IC) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.
Arm/Group Title N165 Randomized Treatment PBO N165 Randomized Treatment LEV
Hide Arm/Group Description:
Subjects received Placebo (PBO) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Subjects received Levetiracetam (LEV) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Overall Number of Participants Analyzed 18 42
Median (Inter-Quartile Range)
Unit of Measure: Number of Seizures (Type IC) per week
>= 1 d - <= 3 m Number Analyzed 18 participants 40 participants
0.00
(0.00 to 0.31)
0.00
(0.00 to 0.19)
> 3 m - <= 6 m Number Analyzed 15 participants 39 participants
0.00
(0.00 to 0.13)
0.00
(0.00 to 0.07)
> 6 m - <= 9 m Number Analyzed 14 participants 37 participants
0.05
(0.00 to 0.19)
0.00
(0.00 to 0.13)
> 9 m - <= 12 m Number Analyzed 14 participants 37 participants
0.06
(0.00 to 0.17)
0.00
(0.00 to 0.06)
> 12 m - <= 15 m Number Analyzed 14 participants 32 participants
0.06
(0.00 to 0.07)
0.00
(0.00 to 0.03)
> 15 m - <= 18 m Number Analyzed 13 participants 30 participants
0.00
(0.00 to 0.13)
0.00
(0.00 to 0.06)
> 18 m - <= 21 m Number Analyzed 11 participants 29 participants
0.00
(0.00 to 0.17)
0.00
(0.00 to 0.00)
> 21 m - <= 24 m Number Analyzed 10 participants 26 participants
0.05
(0.00 to 0.14)
0.00
(0.00 to 0.00)
> 24 m - <= 27 m Number Analyzed 10 participants 25 participants
0.02
(0.00 to 0.17)
0.00
(0.00 to 0.00)
> 27 m - <= 30 m Number Analyzed 11 participants 26 participants
0.04
(0.00 to 0.13)
0.00
(0.00 to 0.00)
> 30 m - <= 33 m Number Analyzed 10 participants 25 participants
0.09
(0.00 to 0.16)
0.00
(0.00 to 0.00)
> 33 m - <= 36 m Number Analyzed 10 participants 25 participants
0.06
(0.00 to 0.13)
0.00
(0.00 to 0.00)
> 36 m - <= 39 m Number Analyzed 10 participants 25 participants
0.04
(0.00 to 0.08)
0.00
(0.00 to 0.00)
> 39 m - <= 42 m Number Analyzed 9 participants 22 participants
0.08
(0.00 to 0.08)
0.00
(0.00 to 0.00)
> 42 m - <= 45 m Number Analyzed 8 participants 12 participants
0.04
(0.00 to 0.19)
0.00
(0.00 to 0.02)
> 45 m - <= 48 m Number Analyzed 6 participants 9 participants
0.02
(0.00 to 0.04)
0.00
(0.00 to 0.00)
> 48 m - <= 51 m Number Analyzed 5 participants 7 participants
0.00
(0.00 to 0.04)
0.00
(0.00 to 0.00)
> 51 m - <= 54 m Number Analyzed 5 participants 4 participants
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
> 54 m Number Analyzed 3 participants 1 participants
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
5.Secondary Outcome
Title Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit
Hide Description

Percentage change from baseline of of Partial (Type I) seizure frequency over the treatment period standardized to 1 week period.

Negative values indicate improvement from Baseline.
Time Frame From Baseline up to 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set included 151 subjects. Only subjects with valid data for Partial (Type I seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.
Arm/Group Title N165 Randomized Treatment PBO N165 Randomized Treatment LEV
Hide Arm/Group Description:
Subjects received Placebo (PBO) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Subjects received Levetiracetam (LEV) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Overall Number of Participants Analyzed 50 101
Median (Inter-Quartile Range)
Unit of Measure: Percent change
>= 1 d - <= 3 m Number Analyzed 50 participants 100 participants
-27.39
(-48.11 to 5.37)
-31.24
(-61.33 to 2.86)
> 3 m - <= 6 m Number Analyzed 43 participants 92 participants
-35.15
(-58.61 to -6.20)
-34.74
(-62.48 to -3.22)
> 6 m - <= 9 m Number Analyzed 40 participants 82 participants
-38.42
(-59.44 to 5.08)
-43.03
(-77.38 to -9.61)
> 9 m - <= 12 m Number Analyzed 39 participants 78 participants
-41.44
(-61.30 to -6.63)
-43.11
(-73.76 to -11.60)
> 12 m - <= 15 m Number Analyzed 35 participants 68 participants
-29.58
(-58.69 to -10.04)
-46.38
(-73.80 to -11.12)
> 15 m - <= 18 m Number Analyzed 32 participants 64 participants
-44.44
(-70.68 to -19.37)
-43.17
(-69.33 to -16.84)
> 18 m - <= 21 m Number Analyzed 30 participants 61 participants
-37.58
(-69.96 to -21.23)
-49.61
(-71.95 to -20.04)
> 21 m - <= 24 m Number Analyzed 30 participants 59 participants
-45.75
(-59.76 to -15.74)
-52.96
(-77.16 to -13.78)
> 24 m - <= 27 m Number Analyzed 30 participants 56 participants
-50.89
(-69.36 to 0.01)
-53.78
(-73.22 to -23.05)
> 27 m - <= 30 m Number Analyzed 30 participants 55 participants
-40.54
(-74.09 to -1.74)
-47.71
(-76.29 to -18.07)
> 30 m - <= 33 m Number Analyzed 29 participants 52 participants
-29.96
(-69.05 to 0.00)
-43.09
(-76.80 to -16.09)
> 33 m - <= 36 m Number Analyzed 29 participants 49 participants
-40.03
(-72.14 to -5.33)
-39.01
(-75.01 to -11.31)
> 36 m - <= 39 m Number Analyzed 28 participants 49 participants
-43.67
(-68.70 to 3.89)
-44.42
(-74.06 to -9.63)
> 39 m - <= 42 m Number Analyzed 27 participants 43 participants
-42.88
(-65.68 to 0.20)
-47.69
(-85.88 to -10.34)
> 42 m - <= 45 m Number Analyzed 20 participants 30 participants
-45.06
(-57.76 to -21.01)
-71.96
(-85.97 to -21.29)
> 45 m - <= 48 m Number Analyzed 16 participants 23 participants
-42.41
(-71.81 to -28.73)
-80.02
(-86.42 to -36.37)
> 48 m - <= 51 m Number Analyzed 12 participants 17 participants
-49.11
(-74.26 to -23.92)
-78.28
(-88.06 to -55.91)
> 51 m - <= 54 m Number Analyzed 10 participants 12 participants
-43.74
(-96.55 to 0.60)
-81.81
(-92.97 to -66.12)
> 54 m Number Analyzed 8 participants 5 participants
-40.72
(-76.94 to -14.12)
-90.00
(-92.17 to -85.37)
6.Secondary Outcome
Title Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit
Hide Description

Percentage change from baseline of of Partial (Type IA) seizure frequency over the treatment period standardized to 1 week period.

Negative values indicate improvement from Baseline.
Time Frame From Baseline up to 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with Type IA seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IA) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.
Arm/Group Title N165 Randomized Treatment PBO (FAS) N165 Randomized Treatment LEV (FAS)
Hide Arm/Group Description:
Subjects received Placebo (PBO) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Subjects received Levetiracetam (LEV) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Overall Number of Participants Analyzed 23 61
Median (Inter-Quartile Range)
Unit of Measure: Percent change
>= 1 d - <= 3 m Number Analyzed 22 participants 51 participants
-79.58
(-89.22 to -24.55)
-45.93
(-88.28 to 14.97)
> 3 m - <= 6 m Number Analyzed 19 participants 49 participants
-77.15
(-95.81 to -43.42)
-58.81
(-83.66 to 9.91)
> 6 m - <= 9 m Number Analyzed 17 participants 44 participants
-71.71
(-100.00 to -39.06)
-61.62
(-86.96 to 45.98)
> 9 m - <= 12 m Number Analyzed 17 participants 42 participants
-66.05
(-100.00 to -42.98)
-69.01
(-99.09 to -24.55)
> 12 m - <= 15 m Number Analyzed 15 participants 37 participants
-37.32
(-96.72 to -19.64)
-78.44
(-100.00 to -43.42)
> 15 m - <= 18 m Number Analyzed 14 participants 35 participants
-79.55
(-100.00 to -46.11)
-71.42
(-93.19 to -9.46)
> 18 m - <= 21 m Number Analyzed 12 participants 34 participants
-83.68
(-100.00 to -39.59)
-66.07
(-97.31 to -19.52)
> 21 m - <= 24 m Number Analyzed 12 participants 34 participants
-82.30
(-99.71 to -50.87)
-73.18
(-87.28 to -7.74)
> 24 m - <= 27 m Number Analyzed 12 participants 31 participants
-72.52
(-99.68 to -49.91)
-74.85
(-91.27 to -33.43)
> 27 m - <= 30 m Number Analyzed 12 participants 29 participants
-74.89
(-98.71 to -46.15)
-76.45
(-95.81 to -12.09)
> 30 m - <= 33 m Number Analyzed 12 participants 29 participants
-80.89
(-98.97 to -48.35)
-78.24
(-89.74 to -4.31)
> 33 m - <= 36 m Number Analyzed 12 participants 27 participants
-84.13
(-100.00 to -48.15)
-80.40
(-96.99 to 9.85)
> 36 m - <= 39 m Number Analyzed 12 participants 27 participants
-90.62
(-100.00 to -53.87)
-76.79
(-97.71 to -27.78)
> 39 m - <= 42 m Number Analyzed 11 participants 24 participants
-92.50
(-100.00 to -42.88)
-75.66
(-96.10 to -18.07)
> 42 m - <= 45 m Number Analyzed 10 participants 19 participants
-77.00
(-99.57 to -47.52)
-74.09
(-93.06 to -39.64)
> 45 m - <= 48 m Number Analyzed 7 participants 16 participants
-71.43
(-91.25 to -47.31)
-79.25
(-95.95 to -41.45)
> 48 m - <= 51 m Number Analyzed 5 participants 11 participants
-54.01
(-95.64 to -48.88)
-91.41
(-100.00 to -56.26)
> 51 m - <= 54 m Number Analyzed 5 participants 9 participants
-64.18
(-100.00 to -42.73)
-83.37
(-98.18 to -71.43)
> 54 m Number Analyzed 4 participants 5 participants
-59.19
(-92.21 to -32.87)
-97.55
(-100.00 to -85.71)
7.Secondary Outcome
Title Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit
Hide Description

Percentage change from baseline of of Partial (Type IB) seizure frequency over the treatment period standardized to 1 week period.

Negative values indicate improvement from Baseline.
Time Frame From Baseline up to 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with Type IB seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IB) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.
Arm/Group Title N165 Randomized Treatment PBO (FAS) N165 Randomized Treatment LEV (FAS)
Hide Arm/Group Description:
Subjects received Placebo (PBO) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Subjects received Levetiracetam (LEV) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Overall Number of Participants Analyzed 44 91
Median (Inter-Quartile Range)
Unit of Measure: Percent change
>= 1 d - <= 3 m Number Analyzed 43 participants 87 participants
-21.41
(-48.68 to 19.61)
-26.77
(-57.30 to 6.25)
> 3 m - <= 6 m Number Analyzed 37 participants 79 participants
-21.95
(-52.22 to 2.27)
-31.35
(-64.47 to 0.53)
> 6 m - <= 9 m Number Analyzed 34 participants 71 participants
-28.30
(-52.22 to 7.30)
-47.61
(-75.99 to -7.14)
> 9 m - <= 12 m Number Analyzed 33 participants 67 participants
-34.97
(-50.02 to 17.70)
-43.56
(-73.35 to -14.31)
> 12 m - <= 15 m Number Analyzed 30 participants 59 participants
-21.12
(-54.73 to 7.78)
-51.20
(-74.85 to 6.18)
> 15 m - <= 18 m Number Analyzed 27 participants 55 participants
-33.18
(-56.67 to 6.88)
-45.80
(-66.80 to -12.59)
> 18 m - <= 21 m Number Analyzed 25 participants 53 participants
-32.78
(-54.73 to 2.63)
-52.04
(-72.79 to -15.92)
> 21 m - <= 24 m Number Analyzed 25 participants 51 participants
-20.12
(-58.09 to 1.17)
-52.96
(-78.82 to -10.93)
> 24 m - <= 27 m Number Analyzed 25 participants 49 participants
-28.75
(-61.84 to 13.15)
-49.71
(-72.31 to -17.12)
> 27 m - <= 30 m Number Analyzed 25 participants 49 participants
-8.84
(-51.80 to 3.05)
-48.18
(-79.29 to -21.93)
> 30 m - <= 33 m Number Analyzed 24 participants 47 participants
-15.85
(-52.14 to 16.16)
-46.86
(-79.88 to -11.48)
> 33 m - <= 36 m Number Analyzed 24 participants 44 participants
-11.73
(-53.45 to 17.68)
-42.03
(-74.93 to -6.07)
> 36 m - <= 39 m Number Analyzed 23 participants 44 participants
-15.06
(-49.40 to 28.76)
-46.25
(-76.15 to 7.85)
> 39 m - <= 42 m Number Analyzed 22 participants 39 participants
-20.13
(-53.31 to 31.25)
-49.85
(-86.73 to 0.00)
> 42 m - <= 45 m Number Analyzed 16 participants 27 participants
-23.76
(-46.47 to 13.76)
-46.51
(-91.95 to -11.07)
> 45 m - <= 48 m Number Analyzed 12 participants 20 participants
-37.52
(-56.10 to -13.36)
-54.05
(-98.11 to -16.56)
> 48 m - <= 51 m Number Analyzed 8 participants 15 participants
-42.17
(-53.57 to 1.70)
-77.08
(-94.99 to -38.37)
> 51 m - <= 54 m Number Analyzed 6 participants 11 participants
5.38
(-44.75 to 10.33)
-74.58
(-100.00 to 42.13)
> 54 m Number Analyzed 5 participants 4 participants
3.55
(-47.49 to 74.45)
-86.61
(-93.85 to -8.06)
8.Secondary Outcome
Title Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit
Hide Description

Percentage change from baseline of of Partial (Type IC) seizure frequency over the treatment period standardized to 1 week period.

Negative values indicate improvement from Baseline.
Time Frame From Baseline up to 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with Type IC seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IC) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.
Arm/Group Title N165 Randomized Treatment PBO N165 Randomized Treatment LEV
Hide Arm/Group Description:
Subjects received Placebo (PBO) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Subjects received Levetiracetam (LEV) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Overall Number of Participants Analyzed 18 42
Median (Inter-Quartile Range)
Unit of Measure: Percent change
>= 1 d - <= 3 m Number Analyzed 15 participants 25 participants
-100.00
(-100.00 to -24.55)
-100.00
(-100.00 to -32.50)
> 3 m - <= 6 m Number Analyzed 12 participants 24 participants
-93.96
(-100.00 to -59.36)
-100.00
(-100.00 to -32.10)
> 6 m - <= 9 m Number Analyzed 11 participants 22 participants
-88.73
(-100.00 to 38.32)
-100.00
(-100.00 to -43.42)
> 9 m - <= 12 m Number Analyzed 11 participants 22 participants
-100.00
(-100.00 to -54.73)
-100.00
(-100.00 to -40.03)
> 12 m - <= 15 m Number Analyzed 11 participants 18 participants
-88.33
(-100.00 to -49.70)
-100.00
(-100.00 to -64.50)
> 15 m - <= 18 m Number Analyzed 11 participants 18 participants
-100.00
(-100.00 to -62.28)
-100.00
(-100.00 to -69.82)
> 18 m - <= 21 m Number Analyzed 9 participants 17 participants
-90.42
(-100.00 to -54.73)
-100.00
(-100.00 to -25.61)
> 21 m - <= 24 m Number Analyzed 9 participants 16 participants
-80.56
(-100.00 to -24.55)
-100.00
(-100.00 to -68.35)
> 24 m - <= 27 m Number Analyzed 9 participants 15 participants
-91.92
(-100.00 to -24.55)
-100.00
(-100.00 to -45.54)
> 27 m - <= 30 m Number Analyzed 9 participants 15 participants
-92.11
(-100.00 to -74.85)
-100.00
(-100.00 to -45.54)
> 30 m - <= 33 m Number Analyzed 8 participants 15 participants
-77.02
(-95.91 to 16.78)
-100.00
(-100.00 to -86.64)
> 33 m - <= 36 m Number Analyzed 8 participants 13 participants
-74.30
(-91.72 to -46.59)
-100.00
(-100.00 to -92.19)
> 36 m - <= 39 m Number Analyzed 8 participants 13 participants
-85.67
(-96.25 to -7.06)
-100.00
(-100.00 to -83.77)
> 39 m - <= 42 m Number Analyzed 7 participants 10 participants
-83.23
(-100.00 to -21.27)
-100.00
(-100.00 to -47.52)
> 42 m - <= 45 m Number Analyzed 6 participants 7 participants
-79.75
(-100.00 to -56.26)
-100.00
(-100.00 to -49.70)
> 45 m - <= 48 m Number Analyzed 4 participants 7 participants
-95.81
(-100.00 to -83.23)
-100.00
(-100.00 to -85.94)
> 48 m - <= 51 m Number Analyzed 4 participants 6 participants
-95.98
(-100.00 to -87.62)
-100.00
(-100.00 to -100.00)
> 51 m - <= 54 m Number Analyzed 4 participants 4 participants
-100.00
(-100.00 to -91.67)
-100.00
(-100.00 to -100.00)
> 54 m Number Analyzed 2 participants 1 participants
-100.00
(-100.00 to -100.00)
-100.00
(-100.00 to -100.00)
Time Frame Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months).
Adverse Event Reporting Description Adverse events refer to the Full Analysis Set (FAS).
 
Arm/Group Title N165 Randomized Treatment PBO (FAS) N165 Randomized Treatment LEV (FAS)
Hide Arm/Group Description Subjects received Placebo (PBO) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day. In the Placebo group the Serious Adverse Events (SAEs) Status epilepticus and Agitation occurred twice in 2 subjects. Subjects received Levetiracetam (LEV) in study N165 [NCT00600509] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
All-Cause Mortality
N165 Randomized Treatment PBO (FAS) N165 Randomized Treatment LEV (FAS)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   1/101 (0.99%) 
Hide Serious Adverse Events
N165 Randomized Treatment PBO (FAS) N165 Randomized Treatment LEV (FAS)
Affected / at Risk (%) Affected / at Risk (%)
Total   12/50 (24.00%)   22/101 (21.78%) 
Blood and lymphatic system disorders     
Lymphadenitis * 1  0/50 (0.00%)  1/101 (0.99%) 
Gastrointestinal disorders     
Abdominal pain lower * 2  1/50 (2.00%)  0/101 (0.00%) 
Enterocolitis * 2  0/50 (0.00%)  1/101 (0.99%) 
Gastric polyps * 2  0/50 (0.00%)  1/101 (0.99%) 
General disorders     
Difficulty in walking * 2  1/50 (2.00%)  0/101 (0.00%) 
Drowning * 2  0/50 (0.00%)  1/101 (0.99%) 
Hyperthermia * 2  0/50 (0.00%)  1/101 (0.99%) 
Hepatobiliary disorders     
Gallbladder polyp * 2  1/50 (2.00%)  0/101 (0.00%) 
Infections and infestations     
Appendicitis * 2  1/50 (2.00%)  0/101 (0.00%) 
Nasopharyngitis * 2  0/50 (0.00%)  1/101 (0.99%) 
Pneumonia * 2  0/50 (0.00%)  3/101 (2.97%) 
Pyelonephritis acute * 2  0/50 (0.00%)  1/101 (0.99%) 
Injury, poisoning and procedural complications     
Ankle fracture * 2  0/50 (0.00%)  1/101 (0.99%) 
Contusion * 2  1/50 (2.00%)  0/101 (0.00%) 
Fall * 2  1/50 (2.00%)  1/101 (0.99%) 
Femoral neck fracture * 2  1/50 (2.00%)  0/101 (0.00%) 
Fractured sacrum * 2  1/50 (2.00%)  0/101 (0.00%) 
Head injury * 2  1/50 (2.00%)  0/101 (0.00%) 
Joint dislocation * 2  0/50 (0.00%)  1/101 (0.99%) 
Neck injury * 2  0/50 (0.00%)  1/101 (0.99%) 
Polytraumatism * 2  1/50 (2.00%)  0/101 (0.00%) 
Rib fracture * 2  0/50 (0.00%)  1/101 (0.99%) 
Skin laceration * 2  0/50 (0.00%)  1/101 (0.99%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Rectal cancer * 2  0/50 (0.00%)  1/101 (0.99%) 
Nervous system disorders     
Convulsion * 2  1/50 (2.00%)  5/101 (4.95%) 
Dyslalia * 2  1/50 (2.00%)  0/101 (0.00%) 
Grand mal convulsion * 2  0/50 (0.00%)  1/101 (0.99%) 
Status epilepticus * 2  2/50 (4.00%)  4/101 (3.96%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy * 2  1/50 (2.00%)  0/101 (0.00%) 
Psychiatric disorders     
Agitation * 2  1/50 (2.00%)  0/101 (0.00%) 
Mental disorder * 2  0/50 (0.00%)  1/101 (0.99%) 
Respiratory, thoracic and mediastinal disorders     
Haemoptysis * 2  0/50 (0.00%)  1/101 (0.99%) 
Pleurisy * 2  0/50 (0.00%)  1/101 (0.99%) 
Surgical and medical procedures     
Abortion induced * 2  1/50 (2.00%)  0/101 (0.00%) 
Mass excision * 2  0/50 (0.00%)  1/101 (0.99%) 
1
Term from vocabulary, MedDRA9.0
2
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
N165 Randomized Treatment PBO (FAS) N165 Randomized Treatment LEV (FAS)
Affected / at Risk (%) Affected / at Risk (%)
Total   48/50 (96.00%)   99/101 (98.02%) 
Eye disorders     
Conjunctivitis * 1  3/50 (6.00%)  2/101 (1.98%) 
Diplopia * 1  3/50 (6.00%)  6/101 (5.94%) 
Gastrointestinal disorders     
Abdominal pain * 1  7/50 (14.00%)  7/101 (6.93%) 
Abdominal pain upper * 1  2/50 (4.00%)  9/101 (8.91%) 
Cheilitis * 1  3/50 (6.00%)  2/101 (1.98%) 
Constipation * 1  4/50 (8.00%)  20/101 (19.80%) 
Diarrhoea * 1  5/50 (10.00%)  27/101 (26.73%) 
Gastritis * 1  4/50 (8.00%)  6/101 (5.94%) 
Gingivitis * 1  1/50 (2.00%)  7/101 (6.93%) 
Nausea * 1  6/50 (12.00%)  13/101 (12.87%) 
Stomatitis * 1  4/50 (8.00%)  11/101 (10.89%) 
Toothache * 1  4/50 (8.00%)  5/101 (4.95%) 
Vomiting * 1  5/50 (10.00%)  13/101 (12.87%) 
General disorders     
Chest pain * 1  4/50 (8.00%)  2/101 (1.98%) 
Malaise * 1  2/50 (4.00%)  6/101 (5.94%) 
Pyrexia * 1  9/50 (18.00%)  14/101 (13.86%) 
Immune system disorders     
Seasonal allergy * 1  3/50 (6.00%)  4/101 (3.96%) 
Infections and infestations     
Dental caries * 1  6/50 (12.00%)  13/101 (12.87%) 
Influenza * 1  2/50 (4.00%)  8/101 (7.92%) 
Nasopharyngitis * 1  38/50 (76.00%)  76/101 (75.25%) 
Pharyngitis * 1  3/50 (6.00%)  8/101 (7.92%) 
Injury, poisoning and procedural complications     
Arthropod sting * 1  3/50 (6.00%)  2/101 (1.98%) 
Contusion * 1  16/50 (32.00%)  29/101 (28.71%) 
Excoriation * 1  9/50 (18.00%)  18/101 (17.82%) 
Joint sprain * 1  5/50 (10.00%)  8/101 (7.92%) 
Mouth injury * 1  2/50 (4.00%)  6/101 (5.94%) 
Open wound * 1  4/50 (8.00%)  6/101 (5.94%) 
Skin laceration * 1  5/50 (10.00%)  14/101 (13.86%) 
Thermal burn * 1  2/50 (4.00%)  10/101 (9.90%) 
Investigations     
Blood alkaline phosphatase increased * 1  3/50 (6.00%)  3/101 (2.97%) 
Blood triglycerides increased * 1  3/50 (6.00%)  6/101 (5.94%) 
Blood urine present * 1  3/50 (6.00%)  2/101 (1.98%) 
Gamma-glutamyltransferase increased * 1  8/50 (16.00%)  16/101 (15.84%) 
Glucose urine present * 1  3/50 (6.00%)  6/101 (5.94%) 
Neutrophil count decreased * 1  0/50 (0.00%)  8/101 (7.92%) 
Protein urine present * 1  5/50 (10.00%)  3/101 (2.97%) 
Weight decreased * 1  3/50 (6.00%)  9/101 (8.91%) 
Weight increased * 1  2/50 (4.00%)  7/101 (6.93%) 
White blood cell count increased * 1  3/50 (6.00%)  3/101 (2.97%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  1/50 (2.00%)  6/101 (5.94%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  5/50 (10.00%)  8/101 (7.92%) 
Back pain * 1  7/50 (14.00%)  11/101 (10.89%) 
Myalgia * 1  1/50 (2.00%)  7/101 (6.93%) 
Pain in extremity * 1  2/50 (4.00%)  8/101 (7.92%) 
Shoulder pain * 1  1/50 (2.00%)  6/101 (5.94%) 
Nervous system disorders     
Convulsion * 1  2/5 (40.00%)  9/101 (8.91%) 
Dizziness * 1  12/50 (24.00%)  20/101 (19.80%) 
Epilepsy * 1  2/50 (4.00%)  6/101 (5.94%) 
Headache * 1  16/50 (32.00%)  28/101 (27.72%) 
Hypoaesthesia * 1  4/50 (8.00%)  4/101 (3.96%) 
Migraine * 1  4/50 (8.00%)  1/101 (0.99%) 
Somnolence * 1  13/50 (26.00%)  25/101 (24.75%) 
Tremor * 1  4/50 (8.00%)  3/101 (2.97%) 
Psychiatric disorders     
Insomnia * 1  8/50 (16.00%)  13/101 (12.87%) 
Renal and urinary disorders     
Pollakiuria * 1  3/50 (6.00%)  5/101 (4.95%) 
Reproductive system and breast disorders     
Dysmenorrhoea * 1  1/50 (2.00%)  7/101 (6.93%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  3/50 (6.00%)  3/101 (2.97%) 
Pharyngolaryngeal pain * 1  2/50 (4.00%)  7/101 (6.93%) 
Rhinitis allergic * 1  5/50 (10.00%)  2/101 (1.98%) 
Rhinorrhoea * 1  3/50 (6.00%)  5/101 (4.95%) 
Upper respiratory tract inflammation * 1  12/50 (24.00%)  22/101 (21.78%) 
Skin and subcutaneous tissue disorders     
Acne * 1  2/50 (4.00%)  8/101 (7.92%) 
Eczema * 1  5/50 (10.00%)  14/101 (13.86%) 
Pruritus * 1  4/50 (8.00%)  3/101 (2.97%) 
Rash * 1  2/50 (4.00%)  8/101 (7.92%) 
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
[Not Specified]
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
Organization: Cares
Phone: +1844 599 ext 2273
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier: NCT00160615    
Other Study ID Numbers: N01020
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: September 18, 2018
Results First Posted: June 10, 2019
Last Update Posted: June 10, 2019