Clinical Trials List
2019-12-01 - 2020-12-31
Phase III
Terminated8
ICD-10G40.011
Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, intractable, with status epilepticus
ICD-10G40.019
Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, intractable, without status epilepticus
ICD-10G40.111
Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, intractable, with status epilepticus
ICD-10G40.119
Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, intractable, without status epilepticus
ICD-9345.51
Partial epilepsy, without mention of impairment of consciousness, with intractable epilepsy
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
UCB Biopharma SPRL
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 施彥丞 Division of Neurology
- Tse-Min Lu Division of Neurology
- Yo-Tsen Liu Division of Neurology
- Wen-Chung Yu Division of Neurology
- 周建成 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- MENG-Han TSAI Division of Neurology
- 陳乃菁 Division of Neurology
- 林致祥 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 張俊偉 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 董欣 Division of Neurology
- WEI-WEN LIN Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Yu-Wan Yang Division of Neurology
- Fu-Yu Lin Division of Neurology
- Kuan-Fei Chen Division of Neurology
- Yuh-Cherng Guo Division of Neurology
- Yi-Ting Hsu Division of Neurology
- Ming-Kuei Lu Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Wei-Pin Hong Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 饒敦 Division of Neurology
- 張楷杰 Division of Neurology
- JEN-KUANG LEE Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Outcome Measures (1) - Change in log-transformed observable focal-onset seizure frequency from Baseline over the 12-week Maintenance Period
Type: Primary
Title: Change in log-transformed observable focal onset
seizure frequency from Baseline over the
12-week Maintenance Period
Time Points: From Baseline over the 12 Week Maintenance Period (up to Week 16)
Description :
During the study, subjects will keep diaries to record daily seizure activity. Seizure frequency refers to 28-day adjusted frequency. Seizure frequency will be based on investigator assessment of subjects’ reports of daily seizure type and frequency. Observable focal-onset seizures refer to Type IA1, IB, and IC (ILAE Classification of Epileptic Seizures, 1981).
Outcome Measures (2) - Incidence of Treatment Emergent Adverse Events (TEAEs)
Type: Primary
Title: Incidence of Treatment-Emergent Adverse
Events (TEAEs)
Time Points: From Baseline until Safety Follow-Up (up to Week 23)
Description :
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Outcome Measures (3) - Incidence of Treatment-Emergent Adverse Events (TEAEs) leading to study withdrawal
Type: Primary
Title: Incidence of Treatment-Emergent Adverse Events (TEAEs) leading to study withdrawal
Time Points: From Baseline until Safety Follow-Up (up to Week 23)
Description :
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Outcome Measures (4) - Incidence of treatment-emergent serious adverse events (SAEs)
Type: Primary
Title: Incidence of treatment-emergent serious
adverse events (SAEs)
Time Points: From Baseline until Safety Follow-Up (up to Week 23)
Description :
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
- Results in death
- Is life-threatening
- Requires in patient hospitalization or prolongation of existing hospitalization
- Is a congenital anomaly or birth defect
- Is as infection that requires treatment parenteral antibiotics
- Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.
Outcome Measures (5) - 75% responder rate from Baseline over the 12-week Maintenance Period
Type: Secondary
Title: 75% responder rate from Baseline over the 12-
week Maintenance Period
Time Points: From Baseline over the 12 Week Maintenance Period (up to Week 16)
Description: The 75 % responder rate is defined as a >= 75% reduction in observable focal-onset seizure frequency.
Outcome Measures (6) - 50% responder rate from Baseline, over the 12-week Maintenance Period
Type: Secondary
Title: 50% responder rate from Baseline, over the 12-
week Maintenance Period
Time Points: From Baseline over the 12 Week Maintenance Period (up to Week 16)
Description: The 50% responder rate status, defined as a ≥50% reduction in observable focal-onset seizure frequency.
Outcome Measures (7) - Percent change in observable focal-onset seizure frequency from Baseline over the 12-week Maintenance Period
Type: Secondary
Title: Percent change in observable focal-onset seizure frequency from Baseline over the 12-week Maintenance Period
Time Points: From Baseline over the 12 Week Maintenance Period (up to Week 16)
Description :
During the study, subjects will keep diaries to record daily seizure activity. The percentage of participants who experienced a 50 % or greater reduction in seizure frequency per 28 days relative to Baseline (responders) will be assessed.
Primary end point(s) (1) - English
Primary end point(s) :
1. 75% responder rate from Baseline over the 12-week Maintenance Period
2. Incidence of Treatment-Emergent Adverse Events (TEAEs)
3. Incidence of Treatment-Emergent Adverse Events (TEAEs) leading to study withdrawal
4. Incidence of treatment-emergent serious adverse events (SAEs)
Timepoint(s) of evaluation of this end point (1) - English
Timepoint(s) of evaluation of this end point:
1: From Baseline over the 12 Week Maintenance Period (up to Week 16)
2-4: From Baseline until Safety Follow-Up (up to Week 23) Secondary end point(s) (1) – English
Secondary end point(s) :
1. Change in log-transformed observable focal-onset seizure frequency from Baseline over the 12-week Maintenance Period
2. 50% responder rate status, from Baseline, over the 12-week Maintenance Period
3. Percent change in observable focal-onset seizure frequency from Baseline over the 12-week Maintenance Period
Timepoint(s) of evaluation of this end point (1) - English
Timepoint(s) of evaluation of this end point:
1 - 3: From Baseline until Safety Follow-Up (up to Week 23)
Inclution Criteria
- Subject has failed to achieve seizure control with >=4 tolerated and appropriately chosen prior antiepileptic drugs (AED), including past and ongoing treatment, that were individually optimized for adequate dose and duration. Prior discontinued AED treatment would need to be assessed by the Investigator considering the patient medical records and patient and/or caregiver interview. ′Prior AED′ is defined as all past and ongoing AED treatments with a start date before the Screening Visit (Visit 1)
- Average of >= 4 spontaneous and observable focal seizures (type IA1 (i.e. focal aware), IB
(i.e. focal impaired awareness), IC (i.e. focal to bilateral tonic-clonic)) per month
- Current treatment with an individually optimized and stable dose of at least 1 and up to 3
AEDs for the 8 weeks prior to the Screening Visit with or without additional Vagus Nerve
Stimulation (VNS) or other neurostimulation treatments
Exclusion Criteria
- Subject has a history of or signs of generalized or combined generalized and focal epilepsy
- Cluster seizures which are uncountable in the previous 8 weeks before study entry and during 4 weeks prospective baseline
- Current treatment with carbamazepine, phenytoin, primidone, phenobarbital
- Current treatment/ use of (non-AED) prescription, nonprescription, dietary (e.g., grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 or 2C19 pathway for 2 weeks (or 5 half-lives, whichever is longer) prior to the Baseline Visit
- Subjects taking sensitive substrates of CYP2C19 for 2 weeks (or 5 half-lives, whichever is
longer) prior to the Baseline Visit
- Subject has been taking vigabatrin less than 2 years at study entry
- Subject has been taking felbamate for less than 12 months
- Subject taking retigabine for less than 4 years
- Current treatment with benzodiazepines (i.e. GABA-A-ergic drugs like zolpidem, zaleplon, or zopiclone, excluding GABA-A-ergic AEDs) <3 times per week for emergencies
- Subject has a current medical condition that occurred within the last 12 months which, in the opinion of the investigator, could compromise his/her safety or ability to participate in this study
The Estimated Number of Participants
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Taiwan
25 participants
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Global
625 participants
