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Trial record 1 of 1 for:    NCT00419094
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Conversion to Monotherapy Study With Keppra XR for Partial Seizures

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ClinicalTrials.gov Identifier: NCT00419094
Recruitment Status : Completed
First Posted : January 8, 2007
Results First Posted : December 20, 2010
Last Update Posted : September 5, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Keppra XR
Enrollment 228
Recruitment Details The Efficacy (EFF) population is defined as all subjects in the Intent to Treat (ITT) population who enter into the Previous Antiepileptic (AED) Discontinuation (D/C) Phase. The Per Protocol (PP) population consists of all subjects in the EFF population who have no important protocol deviations related to efficacy.
Pre-assignment Details Subjects are to be randomized into treatment with either Keppra XR 2000 mg/day or Keppra XR 1000 mg/day in a 3:1 ratio.
Arm/Group Title Keppra XR 1000 mg/Day Keppra XR 2000 mg/Day
Hide Arm/Group Description 1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily) 2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
Period Title: Overall Study
Started 57 [1] 171
Completed 50 141
Not Completed 7 30
Reason Not Completed
Adverse Event             3             7
Lack of Efficacy             1             0
Lost to Follow-up             0             2
Protocol Violation             1             14
Withdrawal of consent             1             5
Other: Error determining exit criteria             1             0
Other: Patient non-compliant             0             1
Other: No contact for extended period             0             1
[1]
Number started refers to number randomized; 303 subjects were screened/enrolled and 228 randomized.
Arm/Group Title Keppra XR 1000 mg/Day Keppra XR 2000 mg/Day Total
Hide Arm/Group Description 1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily) 2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily) Total of all reporting groups
Overall Number of Baseline Participants 57 171 228
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 171 participants 228 participants
<=18 years
11
  19.3%
31
  18.1%
42
  18.4%
Between 18 and 65 years
43
  75.4%
140
  81.9%
183
  80.3%
>=65 years
3
   5.3%
0
   0.0%
3
   1.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 171 participants 228 participants
33.48  (16.32) 34.31  (13.69) 34.11  (14.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 171 participants 228 participants
Female
33
  57.9%
99
  57.9%
132
  57.9%
Male
24
  42.1%
72
  42.1%
96
  42.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 57 participants 171 participants 228 participants
United States 8 29 37
Mexico 17 43 60
Poland 16 51 67
Russian Federation 16 48 64
1.Primary Outcome
Title The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
Hide Description Cumulative exit rate at day 112, based on the duration between start date of previous AED tapering to the earliest date exit criterion was met; calculated using Kaplan Meier Methods. Subjects prematurely discontinued for reasons unrelated to exit criteria were censored as of last dose of study drug. Subjects who completed without meeting exit criteria were censored at Day 112. Exit criteria include increase in seizure frequency, severity, duration, status epilepticus, or new generalized seizure. Upper 95% 2-sided confidence limit for exit rate is compared to the historical control rate: 0.678.
Time Frame 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Primary Efficacy analysis was conducted for the Keppra XR 2000 mg/day group only.
Arm/Group Title Keppra XR 1000 mg/Day Keppra XR 2000 mg/Day
Hide Arm/Group Description:
1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
Overall Number of Participants Analyzed 0 158
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of subjects
0.375
(0.297 to 0.453)
2.Secondary Outcome
Title The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase
Hide Description The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who prematurely discontinued for reasons unrelated to exit criteria, adverse event, or lack of efficacy were censored as of the last dose of study medication. Subjects who completed the study without having an exit event were censored as of Day 112.
Time Frame 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Evaluated for Keppra XR 2000 mg/day only.
Arm/Group Title Keppra XR 1000 mg/Day Keppra XR 2000 mg/Day
Hide Arm/Group Description:
1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
Overall Number of Participants Analyzed 0 158
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of subjects
0.385
(0.307 to 0.463)
3.Secondary Outcome
Title The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase
Hide Description The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who completed the study without having an exit event were censored as of Day 112.
Time Frame 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Evaluated for Keppra XR 2000 mg/day only.
Arm/Group Title Keppra XR 1000 mg/Day Keppra XR 2000 mg/Day
Hide Arm/Group Description:
1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
Overall Number of Participants Analyzed 0 158
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of subjects
0.475
(0.397 to 0.553)
4.Secondary Outcome
Title The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
Hide Description Keppra XR 1000 mg arm was not intended for inferential analysis (planned 3 to 1 randomization, Keppra XR 2000 mg: 1000 mg). The Exit Rate was based on the duration between the start date of previous AED tapering to the earliest date an exit crterion was met. Subjects who prematurely discontinued for reasons unrelated to exit criteria were censored as of the last dose of study medication. Subjects who completed the study without meeting an exit criterion were censored as of Day 112.
Time Frame 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 57 (Keppra 1000 mg) subjects randomized, 54 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population.
Arm/Group Title Keppra XR 1000 mg/Day Keppra XR 2000 mg/Day
Hide Arm/Group Description:
1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
Overall Number of Participants Analyzed 54 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of subjects
0.334
(0.204 to 0.465)
Time Frame Up to 29 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Keppra XR 1000 mg/Day Keppra XR 2000 mg/Day
Hide Arm/Group Description 1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily) 2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
All-Cause Mortality
Keppra XR 1000 mg/Day Keppra XR 2000 mg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Keppra XR 1000 mg/Day Keppra XR 2000 mg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/57 (3.51%)      12/171 (7.02%)    
Gastrointestinal disorders     
haemorrhoidal haemorrhage * 1  0/57 (0.00%)  0 1/171 (0.58%)  1
pancreatitis acute * 1  0/57 (0.00%)  0 1/171 (0.58%)  1
Infections and infestations     
pulmonary tuberculosis * 1  0/57 (0.00%)  0 1/171 (0.58%)  1
pyelonephritis * 1  0/57 (0.00%)  0 1/171 (0.58%)  1
Injury, poisoning and procedural complications     
ankle fracture * 1  0/57 (0.00%)  0 1/171 (0.58%)  1
Musculoskeletal and connective tissue disorders     
back pain * 1  0/57 (0.00%)  0 1/171 (0.58%)  1
intervertebral disc protrusion * 1  0/57 (0.00%)  0 1/171 (0.58%)  1
lumbar spinal stenosis * 1  0/57 (0.00%)  0 1/171 (0.58%)  1
Nervous system disorders     
convulsion * 1  1/57 (1.75%)  1 4/171 (2.34%)  4
status epilepticus * 1  0/57 (0.00%)  0 1/171 (0.58%)  1
Psychiatric disorders     
acute psychosis * 1  1/57 (1.75%)  1 0/171 (0.00%)  0
Vascular disorders     
thrombosis * 1  0/57 (0.00%)  0 1/171 (0.58%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Keppra XR 1000 mg/Day Keppra XR 2000 mg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/57 (57.89%)      87/171 (50.88%)    
Ear and labyrinth disorders     
vertigo * 1  3/57 (5.26%)  3 7/171 (4.09%)  7
Gastrointestinal disorders     
abdominal pain * 1  3/57 (5.26%)  3 6/171 (3.51%)  6
General disorders     
irritablility * 1  3/57 (5.26%)  3 12/171 (7.02%)  12
Infections and infestations     
nasopharyngitis * 1  3/57 (5.26%)  3 7/171 (4.09%)  7
Nervous system disorders     
somnolence * 1  12/57 (21.05%)  13 38/171 (22.22%)  40
headache * 1  13/57 (22.81%)  34 32/171 (18.71%)  55
convulsion * 1  9/57 (15.79%)  9 20/171 (11.70%)  20
dizziness * 1  3/57 (5.26%)  4 15/171 (8.77%)  19
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
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.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: UCB, Inc.
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00419094    
Other Study ID Numbers: N01280
2007-000897-21 ( EudraCT Number )
First Submitted: January 4, 2007
First Posted: January 8, 2007
Results First Submitted: September 13, 2010
Results First Posted: December 20, 2010
Last Update Posted: September 5, 2014