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Trial record 1 of 1 for:    EP0093
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Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant 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: NCT03370120
Recruitment Status : Terminated (Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure)
First Posted : December 12, 2017
Results First Posted : December 29, 2021
Last Update Posted : December 29, 2021
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Drug-Resistant Epilepsy
Focal-Onset Seizures
Intervention Drug: Padsevonil
Enrollment 406
Recruitment Details The study started to enroll study participants in August 2018 and concluded in December 2020.
Pre-assignment Details Participant Flow refers to the Safety Set. Participants who had completed a padsevonil (PSL) parent study (EP0091 [NCT03373383] or EP0092 [NCT03739840]) were enrolled in this study.
Arm/Group Title Padsevonil
Hide Arm/Group Description Participants received padsevonil tablets at a dose of 100 milligrams/day (mg/day) to 800 mg/day up to approximately 2 years.
Period Title: Overall Study
Started 406
Completed 0
Not Completed 406
Reason Not Completed
Adverse event, non-fatal             24
Withdrawal by Subject             6
Lost to Follow-up             1
Lack of Efficacy             37
Per sponsor's instructions             1
Study was terminated by parent company UCB             2
The study was ended by the promoter             3
Discontinuation of drug development             3
End of project             2
Premature study closure             2
Premature program termination             1
Premature study termination             7
Trial terminated by sponsor             2
Trial discontinued by sponsor             2
Study ended             15
Clinical trial has been cancelled             1
End of study per sponsor decision             2
Promoter's decision             2
The trial has been suspended             3
Sponsor stopped PSL development based on data             3
Early termination by order of sponsor             2
Discontinuation of the study             5
End of clinical trial discontinuation             1
Because the clinical trial ended halfway             4
Development discontinued             5
Padsenovil program closed             3
End of project             2
Termination of project             1
The study was interrupted by sponsor             4
The protocol was interrupted by sponsor             1
End of sponsor decision             1
The study was terminated prematurely by study lead             1
Early termination of studies             5
This study is ended early             1
End of padsevonil program             2
Decision of sponsor             6
Asked by the sponsor             3
Sponsor decision to stop the protocol             1
PI decision poor compliance from participant             1
Promoter ended the study             3
Premature study close by sponsor's decision             4
Study terminated by sponsor             33
Sponsor prematurely terminated this study             2
Sponsor decision to terminate study             63
Program closure             3
Study ended prematurely             1
Study stopped by sponsor             2
Program termination             55
Sponsor decision             62
Sponsor study closure             10
Arm/Group Title Padsevonil
Hide Arm/Group Description Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years.
Overall Number of Baseline Participants 406
Hide Baseline Analysis Population Description
The Safety Set (SS) consisted of all enrolled participants who were administered at least 1 dose of PSL, based on the first dose date from the first administration of study medication Case Report form (CRF).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 406 participants
<=18 years
0
   0.0%
Between 18 and 65 years
395
  97.3%
>=65 years
11
   2.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 406 participants
40.8  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 406 participants
Female
231
  56.9%
Male
175
  43.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 406 participants
American Indian / Alaskan native
5
   1.2%
Asian
38
   9.4%
Black
6
   1.5%
Native Hawaiian or other Pacific Islander
5
   1.2%
White
343
  84.5%
Other/mixed
9
   2.2%
1.Primary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Reported by the Participant and/or Caregiver or Observed by the Investigator During the Entire Study
Hide Description An Adverse Event is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Time Frame From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all enrolled participants who were administered at least 1 dose of PSL, based on the first dose date from the first administration of study medication CRF.
Arm/Group Title Padsevonil (SS)
Hide Arm/Group Description:
Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the Safety Set (SS).
Overall Number of Participants Analyzed 406
Measure Type: Number
Unit of Measure: percentage of participants
72.2
2.Primary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal
Hide Description An Adverse Event is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Time Frame From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all enrolled participants who were administered at least 1 dose of PSL, based on the first dose date from the first administration of study medication CRF.
Arm/Group Title Padsevonil (SS)
Hide Arm/Group Description:
Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the SS.
Overall Number of Participants Analyzed 406
Measure Type: Number
Unit of Measure: percentage of participants
5.2
3.Primary Outcome
Title Change From Baseline (From the Respective Parent Study [EP0091 or EP0092]) in Observable Focal-onset Seizure Frequency Over the Evaluation Period
Hide Description Seizure frequency refers to 28-day adjusted frequency. Observable focal-onset seizures refer to Type IAl, IB, and IC (according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981). Focal-onset seizures include all Type I seizures.
Time Frame From Baseline in respective parent study over the Evaluation Period (up to approximately 2 years) in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all enrolled participants who were administered at least 1 dose of PSL or a partial dose of PSL and completed at least 1 seizure diary during the Evaluation Period.
Arm/Group Title Padsevonil (FAS)
Hide Arm/Group Description:
Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the FAS.
Overall Number of Participants Analyzed 406
Mean (Standard Deviation)
Unit of Measure: seizures per 28 days
-7.73  (27.52)
Time Frame From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)
Adverse Event Reporting Description A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
 
Arm/Group Title Padsevonil (SS)
Hide Arm/Group Description Participants received PSL tablets at a dose of 100 mg/day to 800 mg/day up to approximately 2 years. Participants formed the SS.
All-Cause Mortality
Padsevonil (SS)
Affected / at Risk (%)
Total   0/406 (0.00%)    
Hide Serious Adverse Events
Padsevonil (SS)
Affected / at Risk (%) # Events
Total   48/406 (11.82%)    
Endocrine disorders   
Inappropriate antidiuretic hormone secretion * 1  1/406 (0.25%)  1
Gastrointestinal disorders   
Abdominal discomfort * 1  1/406 (0.25%)  1
Large intestinal haemorrhage * 1  1/406 (0.25%)  1
Nausea * 1  1/406 (0.25%)  1
Vomiting * 1  1/406 (0.25%)  1
Hepatobiliary disorders   
Bile duct stone * 1  1/406 (0.25%)  1
Cholecystitis * 1  1/406 (0.25%)  1
Cholelithiasis * 1  1/406 (0.25%)  1
Infections and infestations   
Corona virus infection * 1  1/406 (0.25%)  1
Cytomegalovirus infection * 1  1/406 (0.25%)  1
Gastroenteritis viral * 1  1/406 (0.25%)  1
Pneumonia * 1  1/406 (0.25%)  1
Wound infection * 1  1/406 (0.25%)  1
Injury, poisoning and procedural complications   
Head injury * 1  1/406 (0.25%)  1
Ulna fracture * 1  1/406 (0.25%)  1
Investigations   
Mycoplasma test positive * 1  1/406 (0.25%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Ovarian cancer * 1  1/406 (0.25%)  1
Phyllodes tumour * 1  1/406 (0.25%)  1
Nervous system disorders   
Cervical radiculopathy * 1  1/406 (0.25%)  1
Epilepsy * 1  7/406 (1.72%)  8
Focal dyscognitive seizures * 1  2/406 (0.49%)  2
Generalised tonic-clonic seizure * 1  5/406 (1.23%)  8
Migraine * 1  1/406 (0.25%)  1
Partial seizures * 1  1/406 (0.25%)  1
Partial seizures with secondary generalisation * 1  2/406 (0.49%)  3
Postictal state * 1  1/406 (0.25%)  1
Seizure * 1  4/406 (0.99%)  4
Seizure cluster * 1  2/406 (0.49%)  2
Status epilepticus * 1  5/406 (1.23%)  5
Syncope * 1  1/406 (0.25%)  1
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous * 1  1/406 (0.25%)  1
Pregnancy * 1  1/406 (0.25%)  1
Psychiatric disorders   
Aggression * 1  1/406 (0.25%)  1
Suicide Attempt * 1  1/406 (0.25%)  1
Renal and urinary disorders   
Acute kidney injury * 1  1/406 (0.25%)  1
Pelvi-ureteric obstruction * 1  1/406 (0.25%)  1
Respiratory, thoracic and mediastinal disorders   
Aspiration * 1  1/406 (0.25%)  1
Skin and subcutaneous tissue disorders   
Drug Eruption * 1  1/406 (0.25%)  1
Drug reaction with eosinophilia and systemic symptoms * 1  2/406 (0.49%)  2
Surgical and medical procedures   
Hip arthroplasty * 1  1/406 (0.25%)  1
Vagal nerve stimulator implantation * 1  1/406 (0.25%)  1
Vascular disorders   
Hypotension * 1  1/406 (0.25%)  1
1
Term from vocabulary, MedDRA v22.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Padsevonil (SS)
Affected / at Risk (%) # Events
Total   184/406 (45.32%)    
General disorders   
Fatigue * 1  47/406 (11.58%)  56
Infections and infestations   
Nasopharyngitis * 1  29/406 (7.14%)  42
Nervous system disorders   
Somnolence * 1  66/406 (16.26%)  76
Headache * 1  59/406 (14.53%)  138
Dizziness * 1  43/406 (10.59%)  63
Memory impairment * 1  21/406 (5.17%)  38
Psychiatric disorders   
Insomnia * 1  23/406 (5.67%)  27
1
Term from vocabulary, MedDRA v22.1
*
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: 001-844-599-2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma SRL )
ClinicalTrials.gov Identifier: NCT03370120    
Other Study ID Numbers: EP0093
2017-003241-26 ( EudraCT Number )
First Submitted: December 7, 2017
First Posted: December 12, 2017
Results First Submitted: November 30, 2021
Results First Posted: December 29, 2021
Last Update Posted: December 29, 2021