Trial record 1 of 1 for:
NCT02495844
A Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy
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ClinicalTrials.gov Identifier: NCT02495844 |
Recruitment Status :
Completed
First Posted : July 13, 2015
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
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Sponsor:
UCB Biopharma S.P.R.L.
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
Arm/Group Title | Placebo/UCB0942 | UCB0942/UCB0942 | Total Title | |
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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 | |
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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).
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 27 participants | 28 participants | 55 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
27 100.0%
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28 100.0%
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55 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 27 participants | 28 participants | 55 participants | |
Female |
14 51.9%
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15 53.6%
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29 52.7%
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Male |
13 48.1%
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13 46.4%
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26 47.3%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 27 participants | 28 participants | 55 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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1 3.6%
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1 1.8%
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White |
27 100.0%
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25 89.3%
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52 94.5%
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More than one race |
0 0.0%
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2 7.1%
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2 3.6%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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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 |
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Number Analyzed | 27 participants | 28 participants | 55 participants | |
25.66 (4.82) | 27.20 (4.32) | 26.45 (4.59) |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | UCB |
Organization: | Cares |
Phone: | +1844599 ext 2273 |
EMail: | UCBCares@ucb.com |
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 |