Trial Outcomes & Findings for A Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy (NCT NCT02495844)

Last Updated: 2019-02-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

55 participants

Primary outcome timeframe

During the 2-week Inpatient Period

Results posted on

2019-02-05

Participant Flow

Enrollment started in August 2015 and concluded in July 2017.

Participant Flow refers to the Randomized Set.

Participant milestones

Participant milestones
Measure	Placebo/UCB0942 After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).	UCB0942/UCB0942 Subjects received UCB0942.
Overall Study STARTED	27	28
Overall Study COMPLETED	26	24
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo/UCB0942 After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).	UCB0942/UCB0942 Subjects received UCB0942.
Overall Study Lack of Efficacy	1	2
Overall Study AE, non-fatal	0	1
Overall Study Hepatitis Positivity	0	1

Baseline Characteristics

A Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo/UCB0942 n=27 Participants After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).	UCB0942/UCB0942 n=28 Participants Subjects received UCB0942.	Total Title n=55 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=93 Participants	28 Participants n=4 Participants	55 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	35.2 years STANDARD_DEVIATION 8.7 • n=93 Participants	36.2 years STANDARD_DEVIATION 11.4 • n=4 Participants	35.7 years STANDARD_DEVIATION 10.1 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	15 Participants n=4 Participants	29 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	13 Participants n=4 Participants	26 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	27 Participants n=93 Participants	25 Participants n=4 Participants	52 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	26 Participants n=93 Participants	25 Participants n=4 Participants	51 Participants n=27 Participants
BMI (kg/m^2)	25.66 kg/m^2 STANDARD_DEVIATION 4.82 • n=93 Participants	27.20 kg/m^2 STANDARD_DEVIATION 4.32 • n=4 Participants	26.45 kg/m^2 STANDARD_DEVIATION 4.59 • n=27 Participants

PRIMARY outcome

Timeframe: During the 2-week Inpatient Period

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.

Outcome measures

Outcome measures
Measure	Placebo/UCB0942 (FAS) n=27 Participants After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).	UCB0942/UCB0942 (FAS) n=26 Participants Subjects received UCB0942.
75 % Responder Rate During the 2-week Inpatient Period	11.1 percentage of participants	30.8 percentage of participants

SECONDARY outcome

Timeframe: During the 2-week Inpatient Period

A negative value in median percent change reflects a reduction from Baseline.

Outcome measures

Outcome measures
Measure	Placebo/UCB0942 (FAS) n=27 Participants After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).	UCB0942/UCB0942 (FAS) n=26 Participants Subjects received UCB0942.
Median Percent Change in Weekly Focal Seizure Frequency During the 2-week Inpatient Period	-12.5 percentage of change Interval -57.14 to 41.11	-53.68 percentage of change Interval -84.61 to -22.73

SECONDARY outcome

Timeframe: During the Outpatient Maintenance Period (8 weeks)

A negative value in median percent change reflects a reduction from Baseline.

Outcome measures

Outcome measures
Measure	Placebo/UCB0942 (FAS) n=27 Participants After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).	UCB0942/UCB0942 (FAS) n=25 Participants Subjects received UCB0942.
Median Percent Change in Weekly Focal Seizure Frequency During the Outpatient Maintenance Period	-57.94 percentage of change Interval -76.23 to -29.09	-26.32 percentage of change Interval -77.38 to -3.07

SECONDARY outcome

Timeframe: During the On-UCB0942 Overall Period (approximately 11 weeks)

A negative value in median percent change reflects a reduction from Baseline.

Outcome measures

Outcome measures
Measure	Placebo/UCB0942 (FAS) n=27 Participants After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).	UCB0942/UCB0942 (FAS) n=27 Participants Subjects received UCB0942.
Median Percent Change in Weekly Focal Seizure Frequency During the On-UCB0942 Overall Period	-53.85 percentage of change Interval -78.01 to -34.48	-29.87 percentage of change Interval -76.39 to -11.36

SECONDARY outcome

Timeframe: During the 2-week Inpatient Period

Seizure-free rate is reported as the percentage of seizure-free participants during the 2-week Inpatient Period.

Outcome measures

Outcome measures
Measure	Placebo/UCB0942 (FAS) n=27 Participants After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).	UCB0942/UCB0942 (FAS) n=27 Participants Subjects received UCB0942.
Seizure-free Rate (All Seizures) During the 2-week Inpatient Period	3.7 percentage of particpants	7.4 percentage of particpants

SECONDARY outcome

Timeframe: During the last 4 weeks of the Outpatient Maintenance Period

Seizure-free rate is reported as the percentage of seizure-free participants during the last 4 weeks of the Outpatient Maintenance Period.

Outcome measures

Outcome measures
Measure	Placebo/UCB0942 (FAS) n=27 Participants After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).	UCB0942/UCB0942 (FAS) n=25 Participants Subjects received UCB0942.
Seizure-free Rate (All Seizures) During the Last 4 Weeks of the Outpatient Maintenance Period	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: During the On-UCB0942 Overall Period (approximately 11 weeks)

Seizure-free rate is reported as the percentage of seizure-free participants during the On-UCB0942 Overall Period.

Outcome measures

Outcome measures
Measure	Placebo/UCB0942 (FAS) n=27 Participants After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).	UCB0942/UCB0942 (FAS) n=28 Participants Subjects received UCB0942.
Seizure-free Rate (All Seizures) During the On-UCB0942 Overall Period	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: During the last 4 weeks of the Outpatient Maintenance Period

The 75 % responder rate is defined as the percentage of subjects who achieve a 75 % or greater reduction in focal seizure frequency.

Outcome measures

Outcome measures
Measure	Placebo/UCB0942 (FAS) n=27 Participants After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).	UCB0942/UCB0942 (FAS) n=24 Participants Subjects received UCB0942.
75 % Responder Rate During the Last 4 Weeks of the Outpatient Maintenance Period	33.3 percentage of participants	29.2 percentage of participants

SECONDARY outcome

Timeframe: During the On-UCB0942 Overall Period (approximately 11 weeks)

The 75 % responder rate is defined as the percentage of subjects who achieve a 75 % or greater reduction in focal seizure frequency.

Outcome measures

Outcome measures
Measure	Placebo/UCB0942 (FAS) n=27 Participants After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).	UCB0942/UCB0942 (FAS) n=27 Participants Subjects received UCB0942.
75 % Responder Rate During the On-UCB0942 Overall Period	25.9 percentage of participants	25.9 percentage of participants

SECONDARY outcome

Timeframe: During the 2-week Inpatient Period

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.

Outcome measures

Outcome measures
Measure	Placebo/UCB0942 (FAS) n=27 Participants After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).	UCB0942/UCB0942 (FAS) n=27 Participants Subjects received UCB0942.
Percentage of Seizure Free Days (All Seizures) During the 2-week Inpatient Period	21.43 percentage of days Interval 7.14 to 57.14	57.14 percentage of days Interval 28.57 to 78.57

SECONDARY outcome

Timeframe: During the Outpatient Maintenance Period (8 weeks)

Outcome measures

Outcome measures
Measure	Placebo/UCB0942 (FAS) n=27 Participants After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).	UCB0942/UCB0942 (FAS) n=26 Participants Subjects received UCB0942.
Percentage of Seizure-free Days (All Seizures) During the Outpatient Maintenance Period	51.79 percentage of days Interval 15.79 to 80.7	51.35 percentage of days Interval 29.82 to 69.64

SECONDARY outcome

Timeframe: All study duration (approximately 19 to 20 weeks)

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).

Outcome measures

Outcome measures
Measure	Placebo/UCB0942 (FAS) n=27 Participants After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).	UCB0942/UCB0942 (FAS) n=28 Participants Subjects received UCB0942.
Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study	0 Participants	2 Participants

SECONDARY outcome

Timeframe: All study duration (approximately 19 to 20 weeks)

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).

Outcome measures

Outcome measures
Measure	Placebo/UCB0942 (FAS) n=27 Participants After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).	UCB0942/UCB0942 (FAS) n=28 Participants Subjects received UCB0942.
Number of Subject Withdrawals Due to Adverse Events (AEs) During the Course of the Study	0 Participants	1 Participants

Adverse Events

Placebo/UCB0942

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

UCB0942/UCB0942

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo/UCB0942 n=27 participants at risk After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).	UCB0942/UCB0942 n=28 participants at risk Subjects received UCB0942.
Nervous system disorders Judgement impaired	0.00% 0/27 • Adverse Events were collected from Baseline until Safety Follow Up Visit (up to Week 28). 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).	3.6% 1/28 • Number of events 1 • Adverse Events were collected from Baseline until Safety Follow Up Visit (up to Week 28). 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).
Nervous system disorders Status epilepticus	0.00% 0/27 • Adverse Events were collected from Baseline until Safety Follow Up Visit (up to Week 28). 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).	3.6% 1/28 • Number of events 1 • Adverse Events were collected from Baseline until Safety Follow Up Visit (up to Week 28). 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).
Psychiatric disorders Delirium	0.00% 0/27 • Adverse Events were collected from Baseline until Safety Follow Up Visit (up to Week 28). 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).	3.6% 1/28 • Number of events 1 • Adverse Events were collected from Baseline until Safety Follow Up Visit (up to Week 28). 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).
Psychiatric disorders Dysphoria	0.00% 0/27 • Adverse Events were collected from Baseline until Safety Follow Up Visit (up to Week 28). 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).	3.6% 1/28 • Number of events 1 • Adverse Events were collected from Baseline until Safety Follow Up Visit (up to Week 28). 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).

Other adverse events

Additional Information

UCB

Cares

Phone: +1844599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60