Trial record 1 of 1 for:
NCT03373383
Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy (ARISE)
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ClinicalTrials.gov Identifier: NCT03373383 |
Recruitment Status :
Completed
First Posted : December 14, 2017
Results First Posted : April 9, 2021
Last Update Posted : December 21, 2022
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Sponsor:
UCB Biopharma S.P.R.L.
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 |
Conditions |
Drug-resistant Epilepsy Focal-Onset Seizures |
Interventions |
Drug: Padsevonil Other: Placebo |
Enrollment | 411 |
Participant Flow
Recruitment Details | The study started to enroll patients in February 2018 and concluded in January 2020. |
Pre-assignment Details |
The study included: a 4-week Baseline Period, a 16-week Treatment Period, a 4-week Taper Period (for participants who discontinued or choose not to enroll in the open-label extension study) and a Safety Follow-up Period. Participants continuing to the OLE study had a 3-week Conversion Period. Participant Flow refers to the Randomized Set. |
Arm/Group Title | Placebo | Padsevonil 50mg BID | Padsevonil 100mg BID | Padsevonil 200mg BID | Padsevonil 400mg BID |
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Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19. | Participants were randomized to receive a combination of tablets of padsevonil 50 milligrams (mg) and placebo (as appropriate) to maintain the blinding, twice daily (bid) up to week 19 | Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. | Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. | Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. |
Period Title: Treatment Period: Wk0-16 | |||||
Started | 83 | 81 | 83 | 82 | 82 |
Completed Titration and Stabilization | 78 | 72 | 71 | 68 | 65 |
Completed Maintenance Period | 70 | 66 | 68 | 61 | 58 |
Had Taper and Safety Follow-up | 6 | 11 | 8 | 18 | 21 |
Completed | 70 | 66 | 68 | 61 | 58 |
Not Completed | 13 | 15 | 15 | 21 | 24 |
Reason Not Completed | |||||
Adverse Event | 7 | 6 | 11 | 15 | 21 |
Lack of Efficacy | 2 | 1 | 0 | 0 | 0 |
Protocol Violation | 0 | 4 | 2 | 1 | 0 |
Lost to Follow-up | 2 | 0 | 0 | 0 | 0 |
Withdrawal by Subject | 2 | 3 | 2 | 3 | 3 |
As advised by the sponsor | 0 | 1 | 0 | 0 | 0 |
By opinion of investigator | 0 | 0 | 0 | 1 | 0 |
Sponsor decision | 0 | 0 | 0 | 1 | 0 |
Period Title: Post-Treatment Period: Wk16-23 | |||||
Started | 70 | 66 | 68 | 61 | 58 |
Started Conversion Period | 69 | 64 | 66 | 55 | 57 |
Completed Conversion Period | 68 | 64 | 66 | 55 | 57 |
Had Taper and Safety Follow-up | 3 | 3 | 3 | 6 | 1 |
Enrolled in EP0093 | 67 | 63 | 65 | 55 | 57 |
Completed | 69 | 66 | 68 | 61 | 58 |
Not Completed | 1 | 0 | 0 | 0 | 0 |
Reason Not Completed | |||||
Participant decided not to roll over | 1 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Placebo | Padsevonil 50mg BID | Padsevonil 100mg BID | Padsevonil 200mg BID | Padsevonil 400mg BID | Total Title | |
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Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19. | Participants were randomized to receive a combination of tablets of padsevonil 50 milligrams (mg) and placebo (as appropriate) to maintain the blinding, twice daily (bid) up to week 19 | Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. | Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. | Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. | [Not Specified] | |
Overall Number of Baseline Participants | 83 | 81 | 83 | 82 | 82 | 411 | |
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Baseline characteristics refer to the Randomized Set (RS) consisting of all participants randomized into the study.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 83 participants | 81 participants | 83 participants | 82 participants | 82 participants | 411 participants | |
<=18 years |
0 0.0%
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0 0.0%
|
2 2.4%
|
1 1.2%
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1 1.2%
|
4 1.0%
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Between 18 and 65 years |
82 98.8%
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76 93.8%
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80 96.4%
|
79 96.3%
|
80 97.6%
|
397 96.6%
|
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>=65 years |
1 1.2%
|
5 6.2%
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1 1.2%
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2 2.4%
|
1 1.2%
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10 2.4%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 83 participants | 81 participants | 83 participants | 82 participants | 82 participants | 411 participants | |
40.0 (12.9) | 42.5 (11.6) | 36.9 (13.1) | 40.9 (12.0) | 38.8 (12.1) | 39.8 (12.4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 83 participants | 81 participants | 83 participants | 82 participants | 82 participants | 411 participants | |
Female |
48 57.8%
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46 56.8%
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47 56.6%
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51 62.2%
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43 52.4%
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235 57.2%
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Male |
35 42.2%
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35 43.2%
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36 43.4%
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31 37.8%
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39 47.6%
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176 42.8%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 83 participants | 81 participants | 83 participants | 82 participants | 82 participants | 411 participants | |
American Indian or Alaska Native |
1 1.2%
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1 1.2%
|
1 1.2%
|
2 2.4%
|
0 0.0%
|
5 1.2%
|
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Asian |
7 8.4%
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7 8.6%
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5 6.0%
|
7 8.5%
|
7 8.5%
|
33 8.0%
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Black or African American |
2 2.4%
|
1 1.2%
|
1 1.2%
|
2 2.4%
|
2 2.4%
|
8 1.9%
|
|
Native Hawaiian or Other Pacific Islander |
1 1.2%
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1 1.2%
|
1 1.2%
|
1 1.2%
|
1 1.2%
|
5 1.2%
|
|
White |
69 83.1%
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69 85.2%
|
73 88.0%
|
69 84.1%
|
71 86.6%
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351 85.4%
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Other/mixed |
3 3.6%
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2 2.5%
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2 2.4%
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1 1.2%
|
1 1.2%
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9 2.2%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | UCB |
Organization: | Cares |
Phone: | +1844 599 ext 2273 |
EMail: | UCBCares@ucb.com |
Responsible Party: | UCB Pharma ( UCB Biopharma S.P.R.L. ) |
ClinicalTrials.gov Identifier: | NCT03373383 |
Other Study ID Numbers: |
EP0091 2017-003200-48 ( EudraCT Number ) |
First Submitted: | December 7, 2017 |
First Posted: | December 14, 2017 |
Results First Submitted: | January 28, 2021 |
Results First Posted: | April 9, 2021 |
Last Update Posted: | December 21, 2022 |