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CompletedNCT00160615Updated Jun 10, 2019Results posted

Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

A Phase 3 interventional study of Levetiracetam in Epilepsy, Partial, sponsored by UCB Japan Co. Ltd.. Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2019-06-10.

Sponsored by UCB Japan Co. Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled Sep 2001, registered Sep 2005).
Phase
Phase 3
Study type
Interventional
Enrollment
154
Allocation
Non-randomized
Ages
16 Years and older
Sex
All
01

Study summary

The safety and efficacy of L059 was evaluated in patients who completed "N165 Clinical Trial of L059". They received L059 at a daily dose from 1,000 mg to 3,000 mg in addition to their standard concomitant AEDs

02

Conditions studied

  • Epilepsy, Partial

Keywords

  • Epilepsy, partial
  • Keppra
  • Levetiracetam
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 154 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

UCB Japan Co. Ltd. is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059
  • Patients/the parent or guardian wish to continue treatment with L059 and to enter N165 Follow-up Study, and also the investigator admit the necessity of the repeated intake of the investigational drug for the patients.

Exclusion criteria

Exclusion Criteria:

  • Patients who had not participate in N165 Clinical Trial of L059.
  • Patients who had participated in N165 Clinical Trial of L059 with no intention of entering the follow-up study taking the same medication.
  • Patients had not been in compliance with requirements of Protocol for N165 Clinical Trial of L059 in the course of the study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
154 participants (actual)

Study arms

  • Experimental
    Levetiracetam

    Subjects received oral tablets of Levetiracetam. This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).

    Drug: Levetiracetam

Interventions

  • DrugLevetiracetam

    * Pharmaceutical form: Film-coating tablets * Concentration: 250 mg/ 500 mg * Route of administration: oral use

    Also known as: Keppra

06

What researchers measure

Primary outcomes

  1. Partial (Type I) Seizure Frequency Per Week by Analysis Visit

    Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.

    Time frame: From Baseline up to 54 months

  2. Partial (Type IA) Seizure Frequency Per Week by Analysis Visit

    Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.

    Time frame: From Baseline up to 54 months

  3. Partial (Type IB) Seizure Frequency Per Week by Analysis Visit

    Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.

    Time frame: From Baseline up to 54 months

  4. Partial (Type IC) Seizure Frequency Per Week by Analysis Visit

    Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.

    Time frame: From Baseline up to 54 months

Secondary outcomes

  1. Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit

    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

  2. Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit

    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

  3. Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit

    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

  4. Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit

    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

07

Results

Posted Jun 10, 2019

Participant flow

The study started to enroll patients in September 2001 and concluded in January 2007.

Participant flow — Overall Study
MilestoneN165 Randomized Treatment PBON165 Randomized Treatment LEV
Started50101
Completed3256
Not completed1845
Withdrew: Adverse event512
Withdrew: Withdrawal by subject02
Withdrew: Lack of efficacy1123
Withdrew: Patient decision12
Withdrew: Investigator decision11
Withdrew: Ae agents had to be discontinued (exam.)01
Withdrew: Switch to surgical treatment02
Withdrew: Non-compliance was suspected01
Withdrew: Poor compliance01

Outcome measures

PrimaryPartial (Type I) Seizure Frequency Per Week by Analysis Visit

Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.

Time frame:
From Baseline up to 54 months
Reported as:
Median · Number of Seizures (Type I) per week
Partial (Type I) Seizure Frequency Per Week by Analysis Visit
Number of Seizures (Type I) per weekN165 Randomized Treatment PBON165 Randomized Treatment LEV
>= 1 day(d) - <= 3 months(m)1.68 (1.18 to 4.06)2.19 (0.99 to 5.41)
> 3 m - <= 6 m1.69 (1.00 to 2.75)2.00 (0.87 to 4.48)
> 6 m - <= 9 m1.58 (0.88 to 2.69)1.78 (0.68 to 4.94)
> 9 m - <= 12 m1.41 (0.95 to 3.25)1.60 (0.60 to 5.05)
> 12 m - <= 15 m1.58 (1.06 to 2.50)1.55 (0.80 to 4.67)
> 15 m - <= 18 m1.36 (1.03 to 2.32)1.69 (0.75 to 4.80)
> 18 m - <= 21 m1.35 (0.72 to 1.96)1.51 (0.62 to 4.49)
> 21 m - <= 24 m1.30 (0.75 to 1.98)1.36 (0.67 to 3.17)
> 24 m - <= 27 m1.25 (0.56 to 2.38)1.33 (0.82 to 2.80)
> 27 m - <= 30 m1.30 (0.66 to 2.46)1.28 (0.72 to 2.75)
> 30 m - <= 33 m1.21 (0.71 to 2.65)1.33 (0.77 to 2.83)
> 33 m - <= 36 m1.14 (0.68 to 2.69)1.30 (0.71 to 3.31)
> 36 m - <= 39 m1.20 (0.65 to 2.92)1.28 (0.75 to 3.32)
> 39 m - <= 42 m1.25 (0.50 to 2.91)1.32 (0.58 to 2.62)
> 42 m - <= 45 m1.17 (0.79 to 2.41)1.28 (0.60 to 2.49)
> 45 m - <= 48 m0.95 (0.54 to 2.05)1.09 (0.25 to 1.58)
> 48 m - <= 51 m0.90 (0.31 to 1.61)0.70 (0.14 to 1.42)
> 51 m - <= 54 m1.06 (0.08 to 2.17)0.78 (0.11 to 1.33)
> 54 m1.16 (0.27 to 1.65)0.09 (0.08 to 1.16)
PrimaryPartial (Type IA) Seizure Frequency Per Week by Analysis Visit

Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.

Time frame:
From Baseline up to 54 months
Reported as:
Median · Number of Seizures (Type IA) per week
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit
Number of Seizures (Type IA) per weekN165 Randomized Treatment PBON165 Randomized Treatment LEV
>= 1 d - <= 3 m0.86 (0.07 to 1.73)0.68 (0.06 to 4.41)
> 3 m - <= 6 m0.32 (0.06 to 1.44)0.83 (0.06 to 3.31)
> 6 m - <= 9 m0.24 (0.00 to 1.33)0.63 (0.05 to 4.67)
> 9 m - <= 12 m0.26 (0.00 to 1.23)0.50 (0.00 to 3.47)
> 12 m - <= 15 m0.57 (0.09 to 1.35)0.22 (0.00 to 2.74)
> 15 m - <= 18 m0.27 (0.00 to 1.32)0.30 (0.00 to 2.81)
> 18 m - <= 21 m0.10 (0.00 to 1.38)0.42 (0.00 to 1.82)
> 21 m - <= 24 m0.17 (0.06 to 1.00)0.43 (0.05 to 1.60)
> 24 m - <= 27 m0.29 (0.00 to 1.10)0.25 (0.00 to 1.41)
> 27 m - <= 30 m0.44 (0.00 to 1.06)0.17 (0.00 to 1.41)
> 30 m - <= 33 m0.24 (0.00 to 0.98)0.25 (0.08 to 1.32)
> 33 m - <= 36 m0.17 (0.00 to 0.83)0.29 (0.05 to 1.63)
> 36 m - <= 39 m0.14 (0.00 to 0.40)0.13 (0.04 to 1.50)
> 39 m - <= 42 m0.17 (0.00 to 0.83)0.28 (0.04 to 1.29)
> 42 m - <= 45 m0.09 (0.00 to 1.13)0.44 (0.08 to 1.03)
> 45 m - <= 48 m0.20 (0.08 to 0.97)0.48 (0.09 to 1.38)
> 48 m - <= 51 m0.44 (0.00 to 1.42)0.18 (0.00 to 1.17)
> 51 m - <= 54 m0.62 (0.00 to 1.59)0.17 (0.10 to 0.63)
> 54 m0.87 (0.14 to 1.65)0.08 (0.00 to 0.84)
PrimaryPartial (Type IB) Seizure Frequency Per Week by Analysis Visit

Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.

Time frame:
From Baseline up to 54 months
Reported as:
Median · Number of Seizures (Type IB) per week
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit
Number of Seizures (Type IB) per weekN165 Randomized Treatment PBON165 Randomized Treatment LEV
>= 1 d - <= 3 m1.56 (0.94 to 2.49)1.27 (0.50 to 3.25)
> 3 m - <= 6 m1.51 (0.81 to 2.69)1.13 (0.38 to 3.18)
> 6 m <= 9 m1.30 (0.60 to 2.25)0.92 (0.25 to 2.31)
> 9 m - <= 12 m1.39 (0.80 to 1.88)0.72 (0.24 to 2.11)
> 12 m - <= 15 m1.34 (0.71 to 1.94)0.81 (0.38 to 2.12)
> 15 m - <= 18 m1.25 (0.81 to 2.21)0.81 (0.35 to 1.88)
> 18 m - <= 21 m1.25 (0.72 to 1.95)0.58 (0.31 to 2.34)
> 21 m - <= 24 m1.26 (0.70 to 1.90)0.73 (0.26 to 2.65)
> 24 m - <= 27 m1.21 (0.56 to 2.50)0.85 (0.13 to 2.05)
> 27 m - <= 30 m1.21 (0.66 to 3.33)0.98 (0.15 to 1.74)
> 30 m - <= 33 m1.25 (0.69 to 2.84)0.79 (0.20 to 2.04)
> 33 m - <= 36 m1.15 (0.76 to 2.91)0.96 (0.14 to 2.13)
> 36 m - <= 39 m1.28 (0.80 to 3.43)1.04 (0.17 to 2.48)
> 39 m - <= 42 m1.40 (0.66 to 3.48)0.77 (0.13 to 1.71)
> 42 m - <= 45 m1.22 (0.76 to 2.79)0.89 (0.08 to 1.52)
> 45 m - <= 48 m0.87 (0.46 to 2.89)0.27 (0.00 to 1.36)
> 48 m - <= 51 m0.74 (0.33 to 2.46)0.22 (0.02 to 1.15)
> 51 m - <= 54 m0.80 (0.46 to 3.64)0.19 (0.00 to 1.25)
> 54 m0.72 (0.54 to 1.33)0.09 (0.00 to 0.17)
PrimaryPartial (Type IC) Seizure Frequency Per Week by Analysis Visit

Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.

Time frame:
From Baseline up to 54 months
Reported as:
Median · Number of Seizures (Type IC) per week
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit
Number of Seizures (Type IC) per weekN165 Randomized Treatment PBON165 Randomized Treatment LEV
>= 1 d - <= 3 m0.00 (0.00 to 0.31)0.00 (0.00 to 0.19)
> 3 m - <= 6 m0.00 (0.00 to 0.13)0.00 (0.00 to 0.07)
> 6 m - <= 9 m0.05 (0.00 to 0.19)0.00 (0.00 to 0.13)
> 9 m - <= 12 m0.06 (0.00 to 0.17)0.00 (0.00 to 0.06)
> 12 m - <= 15 m0.06 (0.00 to 0.07)0.00 (0.00 to 0.03)
> 15 m - <= 18 m0.00 (0.00 to 0.13)0.00 (0.00 to 0.06)
> 18 m - <= 21 m0.00 (0.00 to 0.17)0.00 (0.00 to 0.00)
> 21 m - <= 24 m0.05 (0.00 to 0.14)0.00 (0.00 to 0.00)
> 24 m - <= 27 m0.02 (0.00 to 0.17)0.00 (0.00 to 0.00)
> 27 m - <= 30 m0.04 (0.00 to 0.13)0.00 (0.00 to 0.00)
> 30 m - <= 33 m0.09 (0.00 to 0.16)0.00 (0.00 to 0.00)
> 33 m - <= 36 m0.06 (0.00 to 0.13)0.00 (0.00 to 0.00)
> 36 m - <= 39 m0.04 (0.00 to 0.08)0.00 (0.00 to 0.00)
> 39 m - <= 42 m0.08 (0.00 to 0.08)0.00 (0.00 to 0.00)
> 42 m - <= 45 m0.04 (0.00 to 0.19)0.00 (0.00 to 0.02)
> 45 m - <= 48 m0.02 (0.00 to 0.04)0.00 (0.00 to 0.00)
> 48 m - <= 51 m0.00 (0.00 to 0.04)0.00 (0.00 to 0.00)
> 51 m - <= 54 m0.00 (0.00 to 0.00)0.00 (0.00 to 0.00)
> 54 m0.00 (0.00 to 0.00)0.00 (0.00 to 0.00)
SecondaryPercentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit

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
Reported as:
Median · Percent change
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit
Percent changeN165 Randomized Treatment PBON165 Randomized Treatment LEV
>= 1 d - <= 3 m-27.39 (-48.11 to 5.37)-31.24 (-61.33 to 2.86)
> 3 m - <= 6 m-35.15 (-58.61 to -6.20)-34.74 (-62.48 to -3.22)
> 6 m - <= 9 m-38.42 (-59.44 to 5.08)-43.03 (-77.38 to -9.61)
> 9 m - <= 12 m-41.44 (-61.30 to -6.63)-43.11 (-73.76 to -11.60)
> 12 m - <= 15 m-29.58 (-58.69 to -10.04)-46.38 (-73.80 to -11.12)
> 15 m - <= 18 m-44.44 (-70.68 to -19.37)-43.17 (-69.33 to -16.84)
> 18 m - <= 21 m-37.58 (-69.96 to -21.23)-49.61 (-71.95 to -20.04)
> 21 m - <= 24 m-45.75 (-59.76 to -15.74)-52.96 (-77.16 to -13.78)
> 24 m - <= 27 m-50.89 (-69.36 to 0.01)-53.78 (-73.22 to -23.05)
> 27 m - <= 30 m-40.54 (-74.09 to -1.74)-47.71 (-76.29 to -18.07)
> 30 m - <= 33 m-29.96 (-69.05 to 0.00)-43.09 (-76.80 to -16.09)
> 33 m - <= 36 m-40.03 (-72.14 to -5.33)-39.01 (-75.01 to -11.31)
> 36 m - <= 39 m-43.67 (-68.70 to 3.89)-44.42 (-74.06 to -9.63)
> 39 m - <= 42 m-42.88 (-65.68 to 0.20)-47.69 (-85.88 to -10.34)
> 42 m - <= 45 m-45.06 (-57.76 to -21.01)-71.96 (-85.97 to -21.29)
> 45 m - <= 48 m-42.41 (-71.81 to -28.73)-80.02 (-86.42 to -36.37)
> 48 m - <= 51 m-49.11 (-74.26 to -23.92)-78.28 (-88.06 to -55.91)
> 51 m - <= 54 m-43.74 (-96.55 to 0.60)-81.81 (-92.97 to -66.12)
> 54 m-40.72 (-76.94 to -14.12)-90.00 (-92.17 to -85.37)
SecondaryPercentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit

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
Reported as:
Median · Percent change
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit
Percent changeN165 Randomized Treatment PBO (FAS)N165 Randomized Treatment LEV (FAS)
>= 1 d - <= 3 m-79.58 (-89.22 to -24.55)-45.93 (-88.28 to 14.97)
> 3 m - <= 6 m-77.15 (-95.81 to -43.42)-58.81 (-83.66 to 9.91)
> 6 m - <= 9 m-71.71 (-100.00 to -39.06)-61.62 (-86.96 to 45.98)
> 9 m - <= 12 m-66.05 (-100.00 to -42.98)-69.01 (-99.09 to -24.55)
> 12 m - <= 15 m-37.32 (-96.72 to -19.64)-78.44 (-100.00 to -43.42)
> 15 m - <= 18 m-79.55 (-100.00 to -46.11)-71.42 (-93.19 to -9.46)
> 18 m - <= 21 m-83.68 (-100.00 to -39.59)-66.07 (-97.31 to -19.52)
> 21 m - <= 24 m-82.30 (-99.71 to -50.87)-73.18 (-87.28 to -7.74)
> 24 m - <= 27 m-72.52 (-99.68 to -49.91)-74.85 (-91.27 to -33.43)
> 27 m - <= 30 m-74.89 (-98.71 to -46.15)-76.45 (-95.81 to -12.09)
> 30 m - <= 33 m-80.89 (-98.97 to -48.35)-78.24 (-89.74 to -4.31)
> 33 m - <= 36 m-84.13 (-100.00 to -48.15)-80.40 (-96.99 to 9.85)
> 36 m - <= 39 m-90.62 (-100.00 to -53.87)-76.79 (-97.71 to -27.78)
> 39 m - <= 42 m-92.50 (-100.00 to -42.88)-75.66 (-96.10 to -18.07)
> 42 m - <= 45 m-77.00 (-99.57 to -47.52)-74.09 (-93.06 to -39.64)
> 45 m - <= 48 m-71.43 (-91.25 to -47.31)-79.25 (-95.95 to -41.45)
> 48 m - <= 51 m-54.01 (-95.64 to -48.88)-91.41 (-100.00 to -56.26)
> 51 m - <= 54 m-64.18 (-100.00 to -42.73)-83.37 (-98.18 to -71.43)
> 54 m-59.19 (-92.21 to -32.87)-97.55 (-100.00 to -85.71)
SecondaryPercentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit

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
Reported as:
Median · Percent change
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit
Percent changeN165 Randomized Treatment PBO (FAS)N165 Randomized Treatment LEV (FAS)
>= 1 d - <= 3 m-21.41 (-48.68 to 19.61)-26.77 (-57.30 to 6.25)
> 3 m - <= 6 m-21.95 (-52.22 to 2.27)-31.35 (-64.47 to 0.53)
> 6 m - <= 9 m-28.30 (-52.22 to 7.30)-47.61 (-75.99 to -7.14)
> 9 m - <= 12 m-34.97 (-50.02 to 17.70)-43.56 (-73.35 to -14.31)
> 12 m - <= 15 m-21.12 (-54.73 to 7.78)-51.20 (-74.85 to 6.18)
> 15 m - <= 18 m-33.18 (-56.67 to 6.88)-45.80 (-66.80 to -12.59)
> 18 m - <= 21 m-32.78 (-54.73 to 2.63)-52.04 (-72.79 to -15.92)
> 21 m - <= 24 m-20.12 (-58.09 to 1.17)-52.96 (-78.82 to -10.93)
> 24 m - <= 27 m-28.75 (-61.84 to 13.15)-49.71 (-72.31 to -17.12)
> 27 m - <= 30 m-8.84 (-51.80 to 3.05)-48.18 (-79.29 to -21.93)
> 30 m - <= 33 m-15.85 (-52.14 to 16.16)-46.86 (-79.88 to -11.48)
> 33 m - <= 36 m-11.73 (-53.45 to 17.68)-42.03 (-74.93 to -6.07)
> 36 m - <= 39 m-15.06 (-49.40 to 28.76)-46.25 (-76.15 to 7.85)
> 39 m - <= 42 m-20.13 (-53.31 to 31.25)-49.85 (-86.73 to 0.00)
> 42 m - <= 45 m-23.76 (-46.47 to 13.76)-46.51 (-91.95 to -11.07)
> 45 m - <= 48 m-37.52 (-56.10 to -13.36)-54.05 (-98.11 to -16.56)
> 48 m - <= 51 m-42.17 (-53.57 to 1.70)-77.08 (-94.99 to -38.37)
> 51 m - <= 54 m5.38 (-44.75 to 10.33)-74.58 (-100.00 to 42.13)
> 54 m3.55 (-47.49 to 74.45)-86.61 (-93.85 to -8.06)
SecondaryPercentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit

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
Reported as:
Median · Percent change
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit
Percent changeN165 Randomized Treatment PBON165 Randomized Treatment LEV
>= 1 d - <= 3 m-100.00 (-100.00 to -24.55)-100.00 (-100.00 to -32.50)
> 3 m - <= 6 m-93.96 (-100.00 to -59.36)-100.00 (-100.00 to -32.10)
> 6 m - <= 9 m-88.73 (-100.00 to 38.32)-100.00 (-100.00 to -43.42)
> 9 m - <= 12 m-100.00 (-100.00 to -54.73)-100.00 (-100.00 to -40.03)
> 12 m - <= 15 m-88.33 (-100.00 to -49.70)-100.00 (-100.00 to -64.50)
> 15 m - <= 18 m-100.00 (-100.00 to -62.28)-100.00 (-100.00 to -69.82)
> 18 m - <= 21 m-90.42 (-100.00 to -54.73)-100.00 (-100.00 to -25.61)
> 21 m - <= 24 m-80.56 (-100.00 to -24.55)-100.00 (-100.00 to -68.35)
> 24 m - <= 27 m-91.92 (-100.00 to -24.55)-100.00 (-100.00 to -45.54)
> 27 m - <= 30 m-92.11 (-100.00 to -74.85)-100.00 (-100.00 to -45.54)
> 30 m - <= 33 m-77.02 (-95.91 to 16.78)-100.00 (-100.00 to -86.64)
> 33 m - <= 36 m-74.30 (-91.72 to -46.59)-100.00 (-100.00 to -92.19)
> 36 m - <= 39 m-85.67 (-96.25 to -7.06)-100.00 (-100.00 to -83.77)
> 39 m - <= 42 m-83.23 (-100.00 to -21.27)-100.00 (-100.00 to -47.52)
> 42 m - <= 45 m-79.75 (-100.00 to -56.26)-100.00 (-100.00 to -49.70)
> 45 m - <= 48 m-95.81 (-100.00 to -83.23)-100.00 (-100.00 to -85.94)
> 48 m - <= 51 m-95.98 (-100.00 to -87.62)-100.00 (-100.00 to -100.00)
> 51 m - <= 54 m-100.00 (-100.00 to -91.67)-100.00 (-100.00 to -100.00)
> 54 m-100.00 (-100.00 to -100.00)-100.00 (-100.00 to -100.00)

Adverse events

Collected over Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
N165 Randomized Treatment PBO (FAS)0/50 (0%)12/50 (24%)48/50 (96%)
N165 Randomized Treatment LEV (FAS)1/101 (1%)22/101 (21.8%)99/101 (98%)
Most frequent serious events
Showing 10 of 35
Most frequent serious events
EventN165 Randomized Treatment PBO (FAS)N165 Randomized Treatment LEV (FAS)
ConvulsionNervous system disorders1/505/101
Status epilepticusNervous system disorders2/504/101
PneumoniaInfections and infestations0/503/101
Abdominal pain lowerGastrointestinal disorders1/500/101
Difficulty in walkingGeneral disorders1/500/101
Gallbladder polypHepatobiliary disorders1/500/101
AppendicitisInfections and infestations1/500/101
ContusionInjury, poisoning and procedural complications1/500/101
FallInjury, poisoning and procedural complications1/501/101
Femoral neck fractureInjury, poisoning and procedural complications1/500/101
Most frequent other events
Showing 10 of 65
Most frequent other events
EventN165 Randomized Treatment PBO (FAS)N165 Randomized Treatment LEV (FAS)
NasopharyngitisInfections and infestations38/5076/101
ConvulsionNervous system disorders2/59/101
ContusionInjury, poisoning and procedural complications16/5029/101
HeadacheNervous system disorders16/5028/101
DiarrhoeaGastrointestinal disorders5/5027/101
SomnolenceNervous system disorders13/5025/101
DizzinessNervous system disorders12/5020/101
Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders12/5022/101
ConstipationGastrointestinal disorders4/5020/101
PyrexiaGeneral disorders9/5014/101

Baseline characteristics

Full analysis Set (FAS)

Age, Continuous
Age, Continuous(Years)N165 Randomized Treatment PBO (FAS)N165 Randomized Treatment LEV (FAS)Total Title
Mean33.19 ± 9.9931.95 ± 10.1932.36 ± 10.11
Age, Customized
Age, Customized(Participants)N165 Randomized Treatment PBO (FAS)N165 Randomized Treatment LEV (FAS)Total Title
<=18 years268
Between 18 and 65 years4895143
Sex: Female, Male
Sex: Female, Male(Participants)N165 Randomized Treatment PBO (FAS)N165 Randomized Treatment LEV (FAS)Total Title
Female274774
Male235477
08

Study locations

No study locations are listed for this record.

09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00160615
Lead sponsor
UCB Japan Co. Ltd.
Responsible party
Sponsor
First posted
Sep 12, 2005
Start date
Sep 12, 2001
Primary completion
Jan 17, 2007
Completion
Jan 17, 2007
Results posted
Jun 10, 2019
Last update
Jun 10, 2019

Study contacts

UCB Cares
study director · 001 844 599 2273 (UCB)

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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