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Trial record 100 of 146 for:    epilepsy AND Bethesda

A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.

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ClinicalTrials.gov Identifier: NCT00175825
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : August 22, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Epilepsy
Interventions Other: Placebo
Drug: Brivaracetam
Enrollment 210
Recruitment Details The study started to enroll patients in November 2005 and concluded in June 2006.
Pre-assignment Details Participant Flow refers to the Intention-to-treat (ITT) Set. 210 subjects were initially randomized, 2 subjects discontinued due to Lost to Follow-Up before first study drug intake.
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 20 mg/Day Brivaracetam 50 mg/Day
Hide Arm/Group Description Matching Placebo tablets administered twice a day Brivaracetam 5 mg/day, 2.5 mg administered twice a day Brivaracetam 20 mg/day, 10 mg administered twice a day Brivaracetam 50 mg/day, 25 mg administered twice a day
Period Title: Overall Study
Started 54 50 52 52
Completed 49 46 51 51
Not Completed 5 4 1 1
Reason Not Completed
Adverse Event             3             2             1             1
Lost to Follow-up             1             2             0             0
Withdrawal by Subject             1             0             0             0
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 20 mg/Day Brivaracetam 50 mg/Day Total Title
Hide Arm/Group Description Matching Placebo tablets administered twice a day Brivaracetam 5 mg/day, 2.5 mg administered twice a day Brivaracetam 20 mg/day, 10 mg administered twice a day Brivaracetam 50 mg/day, 25 mg administered twice a day [Not Specified]
Overall Number of Baseline Participants 54 50 52 52 208
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Intention-to-Treat (ITT) Set.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 50 participants 52 participants 52 participants 208 participants
<=18 years
3
   5.6%
4
   8.0%
1
   1.9%
5
   9.6%
13
   6.3%
Between 18 and 65 years
51
  94.4%
46
  92.0%
50
  96.2%
47
  90.4%
194
  93.3%
>=65 years
0
   0.0%
0
   0.0%
1
   1.9%
0
   0.0%
1
   0.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 50 participants 52 participants 52 participants 208 participants
33.59  (11.26) 32.72  (12.16) 35.31  (13.66) 30.92  (11.57) 33.15  (12.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 50 participants 52 participants 52 participants 208 participants
Female
30
  55.6%
20
  40.0%
24
  46.2%
24
  46.2%
98
  47.1%
Male
24
  44.4%
30
  60.0%
28
  53.8%
28
  53.8%
110
  52.9%
1.Primary Outcome
Title Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period
Hide Description Calculated as 7-day partial onset seizure frequency.
Time Frame During the 7-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 20 mg/Day Brivaracetam 50 mg/Day
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Brivaracetam 20 mg/day, 10 mg administered twice a day
Brivaracetam 50 mg/day, 25 mg administered twice a day
Overall Number of Participants Analyzed 54 50 52 52
Median (Inter-Quartile Range)
Unit of Measure: Seizures per week
1.81
(0.88 to 3.50)
1.61
(0.75 to 4.34)
1.55
(0.57 to 3.83)
0.92
(0.69 to 2.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 5 mg/Day
Comments ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.240
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent reduction over Placebo
Estimated Value 9.8
Confidence Interval (2-Sided) 95%
-7.2 to 24.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 20 mg/Day
Comments ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.062
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent reduction over Placebo
Estimated Value 14.9
Confidence Interval (2-Sided) 95%
-0.8 to 28.2
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Brivaracetam 50 mg/Day
Comments ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent reduction over Placebo
Estimated Value 22.1
Confidence Interval (2-Sided) 95%
7.6 to 34.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period
Hide Description Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time Frame Baseline, during the 7-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 20 mg/Day Brivaracetam 50 mg/Day
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Brivaracetam 20 mg/day, 10 mg administered twice a day
Brivaracetam 50 mg/day, 25 mg administered twice a day
Overall Number of Participants Analyzed 54 50 52 52
Median (Inter-Quartile Range)
Unit of Measure: percentage of change
-21.7
(-42.99 to 12.04)
-29.91
(-53.33 to -3.83)
-42.56
(-67.92 to 0.44)
-53.04
(-69.33 to -19.56)
3.Secondary Outcome
Title Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period
Hide Description Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period.
Time Frame During the 7-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 20 mg/Day Brivaracetam 50 mg/Day
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Brivaracetam 20 mg/day, 10 mg administered twice a day
Brivaracetam 50 mg/day, 25 mg administered twice a day
Overall Number of Participants Analyzed 54 50 52 52
Median (Inter-Quartile Range)
Unit of Measure: seizures per week
Baseline
2.23
(1.30 to 4.22)
2.21
(1.38 to 5.00)
2.50
(1.50 to 6.06)
1.99
(1.36 to 3.97)
Treatment
1.81
(0.88 to 3.50)
1.61
(0.75 to 4.34)
1.70
(0.59 to 3.97)
0.92
(0.69 to 2.05)
4.Secondary Outcome
Title Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period
Hide Description Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time Frame During the 7-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 20 mg/Day Brivaracetam 50 mg/Day
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Brivaracetam 20 mg/day, 10 mg administered twice a day
Brivaracetam 50 mg/day, 25 mg administered twice a day
Overall Number of Participants Analyzed 54 50 52 52
Median (Inter-Quartile Range)
Unit of Measure: seizures per week
-0.37
(-1.18 to 0.19)
-0.66
(-1.19 to -0.07)
-0.84
(-2.21 to -0.08)
-0.92
(-2.44 to -0.24)
5.Secondary Outcome
Title Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period
Hide Description Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time Frame During the 7-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 20 mg/Day Brivaracetam 50 mg/Day
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Brivaracetam 20 mg/day, 10 mg administered twice a day
Brivaracetam 50 mg/day, 25 mg administered twice a day
Overall Number of Participants Analyzed 54 50 52 52
Median (Inter-Quartile Range)
Unit of Measure: seizures per week
-0.40
(-1.18 to 0.19)
-0.66
(-1.19 to -0.07)
-0.80
(-2.21 to -0.08)
-0.92
(-2.44 to -0.37)
6.Secondary Outcome
Title Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period
Hide Description Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time Frame During the 7-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 20 mg/Day Brivaracetam 50 mg/Day
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Brivaracetam 20 mg/day, 10 mg administered twice a day
Brivaracetam 50 mg/day, 25 mg administered twice a day
Overall Number of Participants Analyzed 54 50 52 52
Median (Inter-Quartile Range)
Unit of Measure: percentage of change
-24.35
(-43.61 to 12.00)
-29.91
(-53.33 to -3.83)
-41.57
(-65.31 to 0.44)
-53.05
(-69.33 to -22.82)
7.Secondary Outcome
Title Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period
Hide Description A responder was defined as a subject with a >= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period.
Time Frame During the 7-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 20 mg/Day Brivaracetam 50 mg/Day
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Brivaracetam 20 mg/day, 10 mg administered twice a day
Brivaracetam 50 mg/day, 25 mg administered twice a day
Overall Number of Participants Analyzed 54 50 52 52
Measure Type: Number
Unit of Measure: percentage of participants
16.7 32.0 44.2 55.8
8.Secondary Outcome
Title Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period
Hide Description Categories of percentage reductions in seizures from baseline were as following: < -25 %; -25 % to <25 %; 25 % to <75 %; 75 % to <100 %; 100 %.
Time Frame During the 7-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 20 mg/Day Brivaracetam 50 mg/Day
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Brivaracetam 20 mg/day, 10 mg administered twice a day
Brivaracetam 50 mg/day, 25 mg administered twice a day
Overall Number of Participants Analyzed 54 50 52 52
Measure Type: Number
Unit of Measure: percentage of participants
< -25% 18.5 8.0 9.6 13.5
-25% to <25% 35.2 38.0 30.8 13.5
25% to <75% 40.7 42.0 40.4 55.8
75% to <100% 1.9 4.0 11.5 9.6
100% 3.7 8.0 7.7 7.7
9.Secondary Outcome
Title Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period
Hide Description A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period.
Time Frame During the 7-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 20 mg/Day Brivaracetam 50 mg/Day
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Brivaracetam 20 mg/day, 10 mg administered twice a day
Brivaracetam 50 mg/day, 25 mg administered twice a day
Overall Number of Participants Analyzed 54 50 52 52
Measure Type: Number
Unit of Measure: percentage of participants
Completed the Period 1.9 8.0 7.7 5.8
Discontinued from the Period 1.9 0 0 0
10.Secondary Outcome
Title Number of Seizure-free Days Per 4 Weeks
Hide Description A day was considered seizure-free, if no seizure was reported during 24 hours.
Time Frame Baseline, during the 7-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 20 mg/Day Brivaracetam 50 mg/Day
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Brivaracetam 20 mg/day, 10 mg administered twice a day
Brivaracetam 50 mg/day, 25 mg administered twice a day
Overall Number of Participants Analyzed 54 50 52 52
Median (Inter-Quartile Range)
Unit of Measure: Days/4 Weeks
22.66
(16.57 to 24.57)
22.86
(15.43 to 25.14)
22.84
(18.57 to 25.71)
24.65
(21.14 to 25.86)
11.Secondary Outcome
Title Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period
Hide Description Number of days to first, fifth, and tenth seizure after baseline.
Time Frame During the 7-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 20 mg/Day Brivaracetam 50 mg/Day
Hide Arm/Group Description:
Matching Placebo tablets administered twice a day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Brivaracetam 20 mg/day, 10 mg administered twice a day
Brivaracetam 50 mg/day, 25 mg administered twice a day
Overall Number of Participants Analyzed 54 50 52 52
Median (95% Confidence Interval)
Unit of Measure: days
Number of days to first seizure after baseline
4.0
(3.0 to 6.0)
4.0
(3.0 to 7.0)
4.5
(2.0 to 8.0)
7.0
(4.0 to 13.0)
Number of days to fifth seizure after baseline
17.0
(13.0 to 22.0)
20.0
(17.0 to 27.0)
18.5
(14.0 to 29.0)
32.5
(23.0 to 42.0)
Number of days to tenth seizure after baseline
32.0
(23.0 to 45.0)
38.0 [1] 
(27.0 to NA)
39.0 [1] 
(23.0 to NA)
57.0 [1] 
(49.0 to NA)
[1]
upper limit is not available
Time Frame Adverse events were collected from Baseline until Safety Visit (up to 3 months).
Adverse Event Reporting Description Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
 
Arm/Group Title Placebo Brivaracetam 5 mg/Day Brivaracetam 20 mg/Day Brivaracetam 50 mg/Day
Hide Arm/Group Description Matching Placebo tablets administered twice a day Brivaracetam 5 mg/day, 2.5 mg administered twice a day Brivaracetam 20 mg/day, 10 mg administered twice a day Brivaracetam 50 mg/day, 25 mg administered twice a day
All-Cause Mortality
Placebo Brivaracetam 5 mg/Day Brivaracetam 20 mg/Day Brivaracetam 50 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/50 (0.00%)   0/52 (0.00%)   0/52 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Brivaracetam 5 mg/Day Brivaracetam 20 mg/Day Brivaracetam 50 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/50 (0.00%)   1/52 (1.92%)   0/52 (0.00%) 
Nervous system disorders         
Neurotoxicity * 1  0/54 (0.00%)  0/50 (0.00%)  1/52 (1.92%)  0/52 (0.00%) 
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Brivaracetam 5 mg/Day Brivaracetam 20 mg/Day Brivaracetam 50 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/54 (27.78%)   13/50 (26.00%)   8/52 (15.38%)   10/52 (19.23%) 
Blood and lymphatic system disorders         
Neutropenia * 1  1/54 (1.85%)  4/50 (8.00%)  2/52 (3.85%)  1/52 (1.92%) 
General disorders         
Fatigue * 1  2/54 (3.70%)  0/50 (0.00%)  2/52 (3.85%)  3/52 (5.77%) 
Infections and infestations         
Influenza * 1  4/54 (7.41%)  4/50 (8.00%)  0/52 (0.00%)  1/52 (1.92%) 
Nervous system disorders         
Dizziness * 1  3/54 (5.56%)  1/50 (2.00%)  0/52 (0.00%)  4/52 (7.69%) 
Headache * 1  4/54 (7.41%)  4/50 (8.00%)  2/52 (3.85%)  1/52 (1.92%) 
Somnolence * 1  4/54 (7.41%)  1/50 (2.00%)  3/52 (5.77%)  3/52 (5.77%) 
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
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
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00175825     History of Changes
Other Study ID Numbers: N01193
First Submitted: September 9, 2005
First Posted: September 15, 2005
Results First Submitted: October 26, 2017
Results First Posted: August 22, 2018
Last Update Posted: October 2, 2018