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Trial record 1 of 1 for:    NCT02495844
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A Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy

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: NCT02495844
Recruitment Status : Completed
First Posted : July 13, 2015
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Highly Drug-resistant Focal Epilepsy
Interventions Drug: UCB0942
Drug: Placebo
Enrollment 55
Recruitment Details Enrollment started in August 2015 and concluded in July 2017.
Pre-assignment Details Participant Flow refers to the Randomized Set.
Arm/Group Title Placebo/UCB0942 UCB0942/UCB0942
Hide Arm/Group Description After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942). Subjects received UCB0942.
Period Title: Overall Study
Started 27 28
Completed 26 24
Not Completed 1 4
Reason Not Completed
Lack of Efficacy             1             2
AE, non-fatal             0             1
Hepatitis Positivity             0             1
Arm/Group Title Placebo/UCB0942 UCB0942/UCB0942 Total Title
Hide Arm/Group Description After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942). Subjects received UCB0942. [Not Specified]
Overall Number of Baseline Participants 27 28 55
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Set consisting of all subjects in the Randomized Set who received at least 1 dose of Investigational Medicinal Product (IMP).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
 100.0%
28
 100.0%
55
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 28 participants 55 participants
35.2  (8.7) 36.2  (11.4) 35.7  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
Female
14
  51.9%
15
  53.6%
29
  52.7%
Male
13
  48.1%
13
  46.4%
26
  47.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   3.6%
1
   1.8%
White
27
 100.0%
25
  89.3%
52
  94.5%
More than one race
0
   0.0%
2
   7.1%
2
   3.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
Hispanic or Latino 1 3 4
Not Hispanic or Latino 26 25 51
BMI (kg/m^2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 27 participants 28 participants 55 participants
25.66  (4.82) 27.20  (4.32) 26.45  (4.59)
1.Primary Outcome
Title 75 % Responder Rate During the 2-week Inpatient Period
Hide Description The 75% responder rate is defined as the percentage of subjects with a 75 % or greater reduction in focal seizure frequency during the 2-week Inpatient Period compared with the Baseline Period.
Time Frame During the 2-week Inpatient Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
Hide Arm/Group Description:
After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
Subjects received UCB0942.
Overall Number of Participants Analyzed 27 26
Measure Type: Number
Unit of Measure: percentage of participants
11.1 30.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo/UCB0942 (FAS), UCB0942/UCB0942 (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0679
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.14
Confidence Interval (2-Sided) 95%
0.90 to 19.06
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Median Percent Change in Weekly Focal Seizure Frequency During the 2-week Inpatient Period
Hide Description A negative value in median percent change reflects a reduction from Baseline.
Time Frame During the 2-week Inpatient Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
Hide Arm/Group Description:
After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
Subjects received UCB0942.
Overall Number of Participants Analyzed 27 26
Median (Inter-Quartile Range)
Unit of Measure: percentage of change
-12.5
(-57.14 to 41.11)
-53.68
(-84.61 to -22.73)
3.Secondary Outcome
Title Median Percent Change in Weekly Focal Seizure Frequency During the Outpatient Maintenance Period
Hide Description A negative value in median percent change reflects a reduction from Baseline.
Time Frame During the Outpatient Maintenance Period (8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
Hide Arm/Group Description:
After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
Subjects received UCB0942.
Overall Number of Participants Analyzed 27 25
Median (Inter-Quartile Range)
Unit of Measure: percentage of change
-57.94
(-76.23 to -29.09)
-26.32
(-77.38 to -3.07)
4.Secondary Outcome
Title Median Percent Change in Weekly Focal Seizure Frequency During the On-UCB0942 Overall Period
Hide Description A negative value in median percent change reflects a reduction from Baseline.
Time Frame During the On-UCB0942 Overall Period (approximately 11 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
Hide Arm/Group Description:
After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
Subjects received UCB0942.
Overall Number of Participants Analyzed 27 27
Median (Inter-Quartile Range)
Unit of Measure: percentage of change
-53.85
(-78.01 to -34.48)
-29.87
(-76.39 to -11.36)
5.Secondary Outcome
Title Seizure-free Rate (All Seizures) During the 2-week Inpatient Period
Hide Description Seizure-free rate is reported as the percentage of seizure-free participants during the 2-week Inpatient Period.
Time Frame During the 2-week Inpatient Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
Hide Arm/Group Description:
After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
Subjects received UCB0942.
Overall Number of Participants Analyzed 27 27
Measure Type: Number
Unit of Measure: percentage of particpants
3.7 7.4
6.Secondary Outcome
Title Seizure-free Rate (All Seizures) During the Last 4 Weeks of the Outpatient Maintenance Period
Hide Description Seizure-free rate is reported as the percentage of seizure-free participants during the last 4 weeks of the Outpatient Maintenance Period.
Time Frame During the last 4 weeks of the Outpatient Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
Hide Arm/Group Description:
After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
Subjects received UCB0942.
Overall Number of Participants Analyzed 27 25
Measure Type: Number
Unit of Measure: percentage of participants
0 0
7.Secondary Outcome
Title Seizure-free Rate (All Seizures) During the On-UCB0942 Overall Period
Hide Description Seizure-free rate is reported as the percentage of seizure-free participants during the On-UCB0942 Overall Period.
Time Frame During the On-UCB0942 Overall Period (approximately 11 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
Hide Arm/Group Description:
After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
Subjects received UCB0942.
Overall Number of Participants Analyzed 27 28
Measure Type: Number
Unit of Measure: percentage of participants
0 0
8.Secondary Outcome
Title 75 % Responder Rate During the Last 4 Weeks of the Outpatient Maintenance Period
Hide Description The 75 % responder rate is defined as the percentage of subjects who achieve a 75 % or greater reduction in focal seizure frequency.
Time Frame During the last 4 weeks of the Outpatient Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
Hide Arm/Group Description:
After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
Subjects received UCB0942.
Overall Number of Participants Analyzed 27 24
Measure Type: Number
Unit of Measure: percentage of participants
33.3 29.2
9.Secondary Outcome
Title 75 % Responder Rate During the On-UCB0942 Overall Period
Hide Description The 75 % responder rate is defined as the percentage of subjects who achieve a 75 % or greater reduction in focal seizure frequency.
Time Frame During the On-UCB0942 Overall Period (approximately 11 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
Hide Arm/Group Description:
After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
Subjects received UCB0942.
Overall Number of Participants Analyzed 27 27
Measure Type: Number
Unit of Measure: percentage of participants
25.9 25.9
10.Secondary Outcome
Title Percentage of Seizure Free Days (All Seizures) During the 2-week Inpatient Period
Hide Description For the active group, the 2-week Inpatient Period refers to the last 2 weeks of the Inpatient Period, while for the Placebo group, it refers to the first 2 weeks of the Inpatient Period.
Time Frame During the 2-week Inpatient Period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
Hide Arm/Group Description:
After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
Subjects received UCB0942.
Overall Number of Participants Analyzed 27 27
Median (Inter-Quartile Range)
Unit of Measure: percentage of days
21.43
(7.14 to 57.14)
57.14
(28.57 to 78.57)
11.Secondary Outcome
Title Percentage of Seizure-free Days (All Seizures) During the Outpatient Maintenance Period
Hide Description [Not Specified]
Time Frame During the Outpatient Maintenance Period (8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
Hide Arm/Group Description:
After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
Subjects received UCB0942.
Overall Number of Participants Analyzed 27 26
Median (Inter-Quartile Range)
Unit of Measure: percentage of days
51.79
(15.79 to 80.70)
51.35
(29.82 to 69.64)
12.Secondary Outcome
Title Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study
Hide Description Number of subjects experiencing at least one serious adverse event (reported by the subject and/or caregiver or observed by the Investigator or inpatient staff).
Time Frame All study duration (approximately 19 to 20 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/UCB0942 (SS) UCB0942/UCB0942 (SS)
Hide Arm/Group Description:
After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
Subjects received UCB0942.
Overall Number of Participants Analyzed 27 28
Measure Type: Number
Unit of Measure: Participants
0 2
13.Secondary Outcome
Title Number of Subject Withdrawals Due to Adverse Events (AEs) During the Course of the Study
Hide Description Number of subjects who withdrew from the study due adverse event (reported by the subject and/or caregiver or observed by the Investigator or inpatient staff).
Time Frame All study duration (approximately 19 to 20 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo/UCB0942 (SS) UCB0942/UCB0942 (SS)
Hide Arm/Group Description:
After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
Subjects received UCB0942.
Overall Number of Participants Analyzed 27 28
Measure Type: Number
Unit of Measure: Participants
0 1
Time Frame Adverse Events were collected from Baseline until Safety Follow Up Visit (up to Week 28).
Adverse Event Reporting Description Baseline Characteristics refer to the Safety Set consisting of all subjects in the Randomized Set who received at least 1 dose of Investigational Medicinal Product (IMP). 2 subjects reported multiple Serious Adverse Events (SAEs).
 
Arm/Group Title Placebo/UCB0942 UCB0942/UCB0942
Hide Arm/Group Description After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942). Subjects received UCB0942.
All-Cause Mortality
Placebo/UCB0942 UCB0942/UCB0942
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)      0/28 (0.00%)    
Hide Serious Adverse Events
Placebo/UCB0942 UCB0942/UCB0942
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      2/28 (7.14%)    
Nervous system disorders     
Judgement impaired * 1  0/27 (0.00%)  0 1/28 (3.57%)  1
Status epilepticus * 1  0/27 (0.00%)  0 1/28 (3.57%)  1
Psychiatric disorders     
Delirium * 1  0/27 (0.00%)  0 1/28 (3.57%)  1
Dysphoria * 1  0/27 (0.00%)  0 1/28 (3.57%)  1
1
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%
Placebo/UCB0942 UCB0942/UCB0942
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/27 (96.30%)      27/28 (96.43%)    
Eye disorders     
Diplopia * 1  1/27 (3.70%)  1 2/28 (7.14%)  2
Vision blurred * 1  1/27 (3.70%)  1 2/28 (7.14%)  5
Gastrointestinal disorders     
Constipation * 1  1/27 (3.70%)  2 3/28 (10.71%)  3
Dry mouth * 1  1/27 (3.70%)  1 2/28 (7.14%)  2
Nausea * 1  0/27 (0.00%)  0 2/28 (7.14%)  2
Abdominal pain upper * 1  2/27 (7.41%)  4 0/28 (0.00%)  0
Diarrhoea * 1  2/27 (7.41%)  3 0/28 (0.00%)  0
Dyspepsia * 1  2/27 (7.41%)  4 0/28 (0.00%)  0
General disorders     
Fatigue * 1  9/27 (33.33%)  14 4/28 (14.29%)  23
Gait disturbance * 1  2/27 (7.41%)  2 3/28 (10.71%)  17
Asthenia * 1  2/27 (7.41%)  2 2/28 (7.14%)  2
Pyrexia * 1  2/27 (7.41%)  2 0/28 (0.00%)  0
Infections and infestations     
Nasopharyngitis * 1  0/27 (0.00%)  0 2/28 (7.14%)  2
Investigations     
Weight increased * 1  3/27 (11.11%)  3 1/28 (3.57%)  1
Metabolism and nutrition disorders     
Decreased appetite * 1  3/27 (11.11%)  3 2/28 (7.14%)  2
Hyponatraemia * 1  2/27 (7.41%)  2 2/28 (7.14%)  2
Musculoskeletal and connective tissue disorders     
Back pain * 1  2/27 (7.41%)  2 1/28 (3.57%)  2
Muscosloskeletal pain * 1  3/27 (11.11%)  5 0/28 (0.00%)  0
Nervous system disorders     
Somnolence * 1  12/27 (44.44%)  16 17/28 (60.71%)  24
Dizziness * 1  12/27 (44.44%)  51 14/28 (50.00%)  19
Headache * 1  6/27 (22.22%)  9 10/28 (35.71%)  13
Tremor * 1  3/27 (11.11%)  3 2/28 (7.14%)  2
Disturbance in attention * 1  1/27 (3.70%)  2 3/28 (10.71%)  3
Dysarthria * 1  2/27 (7.41%)  2 3/28 (10.71%)  5
Memory impairment * 1  1/27 (3.70%)  2 3/28 (10.71%)  6
Nystagmus * 1  3/27 (11.11%)  3 1/28 (3.57%)  1
Amnesia * 1  1/27 (3.70%)  1 2/28 (7.14%)  2
Paraesthesia * 1  1/27 (3.70%)  2 2/28 (7.14%)  2
Seizure * 1  0/27 (0.00%)  0 3/28 (10.71%)  3
Simple partial seizures * 1  1/27 (3.70%)  1 2/28 (7.14%)  5
Ataxia * 1  0/27 (0.00%)  0 2/28 (7.14%)  3
Restless legs syndrome * 1  0/27 (0.00%)  0 2/28 (7.14%)  2
Psychiatric disorders     
Irritability * 1  4/27 (14.81%)  5 5/28 (17.86%)  5
Insomnia * 1  0/27 (0.00%)  0 4/28 (14.29%)  5
Depressed mood * 1  1/27 (3.70%)  1 2/28 (7.14%)  2
Nervousness * 1  2/27 (7.41%)  3 1/28 (3.57%)  1
Disorientation * 1  0/27 (0.00%)  0 2/28 (7.14%)  3
Mood swings * 1  0/27 (0.00%)  0 2/28 (7.14%)  2
Parasomnia * 1  0/27 (0.00%)  0 2/28 (7.14%)  3
Aggression * 1  2/27 (7.41%)  2 0/28 (0.00%)  0
Reproductive system and breast disorders     
Dysmenorrhoea * 1  0/27 (0.00%)  0 3/28 (10.71%)  4
Vascular disorders     
Hypotension * 1  1/27 (3.70%)  1 2/28 (7.14%)  3
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: +1844599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma S.P.R.L. )
ClinicalTrials.gov Identifier: NCT02495844    
Other Study ID Numbers: EP0069
2014-003330-12 ( EudraCT Number )
First Submitted: June 29, 2015
First Posted: July 13, 2015
Results First Submitted: July 18, 2018
Results First Posted: February 5, 2019
Last Update Posted: February 5, 2019