Back to resultsTrial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Participants With Partial Onset Seizures With or Without Secondary Generalization
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Perampanel
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring epilepsy, partial-onset seizures, secondarily generalized seizures
Eligibility Criteria
Inclusion Criteria:
- Have a diagnosis of epilepsy with partial onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy's Classification of Epileptic Seizures (1981)
- Need an initial add-on therapy after failure to control seizures with the first or further monotherapy at the optimal dose and duration
- Despite antiepileptic drug (AED) treatment within the last 8 weeks, participants must have had greater than or equal to 2 partial onset seizures, and the interval between those seizures should be more than 24 hours prior to Visit 1 (Week 0).
- Are currently being treated with stable doses of monotherapy for 8 weeks prior to Visit 1 (Week 0) (Standard AEDs)
- If antidepressants or antianxiety drugs are used, participants must be receiving stable doses and administrations of antidepressants or antianxiety drugs for 8 weeks prior to Visit 1 (Week 0)
Exclusion Criteria:
- Females who are pregnant (positive beta-human chorionic gonadotropin (β-hCG test) or breastfeeding
- Presence of previous history of Lennox-Gastaut syndrome
- Presence of nonmotor simple partial seizures only
- Presence of primary generalized epilepsies or seizures such as absences and/or myoclonic epilepsies
- A history of status epilepticus within 12 weeks before Visit 1 (Week 0)
- Participants on antipsychotics or who have psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of attempted suicide within 1 year before Visit 1 (Week 0)
- Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
- Concomitant use of barbiturates (except for seizure control indication and premedication for electroencephalogram [EEG]) and benzodiazepines (except for seizure control indication) within 8 weeks prior to Visit 1 (Week 0)
- Use of intermittent rescue benzodiazepines (that is, 1 to 2 doses over a 24-hr period considered one-time rescue) 2 or more times in an 8-week period prior to Visit 1 (Week 0)
- Participant who is participating in other intervention clinical trial
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Perampanel 12 mg
Arm Description
During the Titration Period, participants will receive perampanel 2 milligrams per day (mg/day) and be up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants will receive the last dose they achieved at the end of the Titration Period and will continue receiving this dose once daily for the remainder of the study.
Outcomes
Primary Outcome Measures
50 Percent (%) Responder Rate for Partial Onset Seizure With or Without Secondary Generalization
The 50% responder rate was defined as the percentage of participants who achieved at least 50% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period.
Secondary Outcome Measures
75% Responder Rate for Partial Onset Seizure With or Without Secondary Generalization
The 75% responder rate was defined as the percentage of participants who achieved at least 75% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period.
100% Responder Rate (Seizure Free Rate) for Partial Onset Seizure With or Without Secondary Generalization
The 100% responder rate was defined as the percentage of participants who achieved at least 100% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period.
Percent Change From Baseline in Partial Onset Seizure Frequency With or Without Secondary Generalization to the Titration and Maintenance Period
Percent change in the frequency of partial onset seizure with or without secondary generalization was defined as the percent reduction in seizure frequency from baseline to titration period and maintenance period. Percent change from Baseline was calculated as: ([post-Baseline value minus the Baseline value] / Baseline value)*100. A negative percent change from baseline indicates a decrease in partial seizure frequency.
50% Responder Rate in Secondary Generalized Tonic Clonic (GTC) Seizures
The 50% responder rate was defined as the percentage of participants who have achieved at least a 50% reduction from baseline in the frequency of secondary GTC seizure during the Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain.
75% Responder Rate in Secondary GTC Seizures
The 75% responder rate was defined as the percentage of participants who achieved at least a 75% reduction from baseline in seizure frequency of secondary GTC seizure during the Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain.
100% Responder Rate (Seizure Free Rate) in Secondary GTC Seizures
The 100% responder rate was defined as the percentage of participants who have at least a 100% reduction from baseline in the frequency of secondary GTC seizures during the Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain.
Percent Change From Baseline in Secondary GTC Seizure Frequency to the Titration and Maintenance Period
Percent change in the frequency of secondary GTC seizure was defined as the percent reduction in seizure frequency from baseline to Titration Period and Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain. Percent change from Baseline was calculated as: ([post-Baseline value minus the Baseline value] / Baseline value)*100. A negative percent change from baseline indicates a decrease in partial seizure frequency.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02726074
Brief Title
Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Participants With Partial Onset Seizures With or Without Secondary Generalization
Official Title
Multicenter, Open-label Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Patients With Partial Onset Seizures With or Without Secondary Generalization
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 3, 2016 (Actual)
Primary Completion Date
April 26, 2018 (Actual)
Study Completion Date
April 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Korea Inc.
4. Oversight
5. Study Description
Brief Summary
This is a multi-center, open-label, single-arm, phase 4 study to evaluate the efficacy of perampanel added to monotherapy for partial onset seizures with or without secondarily generalized seizures (total seizures).
Detailed Description
This multi-center, open-label, single-arm study evaluating the efficacy of perampanel added to monotherapy for partial onset seizures consists of 2 periods: Titration Period (12 weeks) and Maintenance Period (24 weeks). During the Titration Period, participants will begin receiving perampanel 2 milligrams per day (mg/day) and be up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants will receive the last dose they achieved at the end of the Titration Period and will continue receiving this dose once daily for the remainder of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
epilepsy, partial-onset seizures, secondarily generalized seizures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perampanel 12 mg
Arm Type
Experimental
Arm Description
During the Titration Period, participants will receive perampanel 2 milligrams per day (mg/day) and be up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants will receive the last dose they achieved at the end of the Titration Period and will continue receiving this dose once daily for the remainder of the study.
Intervention Type
Drug
Intervention Name(s)
Perampanel
Other Intervention Name(s)
E2007
Primary Outcome Measure Information:
Title
50 Percent (%) Responder Rate for Partial Onset Seizure With or Without Secondary Generalization
Description
The 50% responder rate was defined as the percentage of participants who achieved at least 50% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period.
Time Frame
Baseline up to Week 36
Secondary Outcome Measure Information:
Title
75% Responder Rate for Partial Onset Seizure With or Without Secondary Generalization
Description
The 75% responder rate was defined as the percentage of participants who achieved at least 75% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period.
Time Frame
Baseline up to Week 36
Title
100% Responder Rate (Seizure Free Rate) for Partial Onset Seizure With or Without Secondary Generalization
Description
The 100% responder rate was defined as the percentage of participants who achieved at least 100% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period.
Time Frame
Baseline up to Week 36
Title
Percent Change From Baseline in Partial Onset Seizure Frequency With or Without Secondary Generalization to the Titration and Maintenance Period
Description
Percent change in the frequency of partial onset seizure with or without secondary generalization was defined as the percent reduction in seizure frequency from baseline to titration period and maintenance period. Percent change from Baseline was calculated as: ([post-Baseline value minus the Baseline value] / Baseline value)*100. A negative percent change from baseline indicates a decrease in partial seizure frequency.
Time Frame
Weeks 12 and 36
Title
50% Responder Rate in Secondary Generalized Tonic Clonic (GTC) Seizures
Description
The 50% responder rate was defined as the percentage of participants who have achieved at least a 50% reduction from baseline in the frequency of secondary GTC seizure during the Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain.
Time Frame
Baseline up to Week 36
Title
75% Responder Rate in Secondary GTC Seizures
Description
The 75% responder rate was defined as the percentage of participants who achieved at least a 75% reduction from baseline in seizure frequency of secondary GTC seizure during the Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain.
Time Frame
Baseline up to Week 36
Title
100% Responder Rate (Seizure Free Rate) in Secondary GTC Seizures
Description
The 100% responder rate was defined as the percentage of participants who have at least a 100% reduction from baseline in the frequency of secondary GTC seizures during the Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain.
Time Frame
Baseline up to Week 36
Title
Percent Change From Baseline in Secondary GTC Seizure Frequency to the Titration and Maintenance Period
Description
Percent change in the frequency of secondary GTC seizure was defined as the percent reduction in seizure frequency from baseline to Titration Period and Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain. Percent change from Baseline was calculated as: ([post-Baseline value minus the Baseline value] / Baseline value)*100. A negative percent change from baseline indicates a decrease in partial seizure frequency.
Time Frame
Weeks 12 and 36
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame
From the first dose of investigational product to the last visit or 28 days after the last dose (up to 1 year 11 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of epilepsy with partial onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy's Classification of Epileptic Seizures (1981)
Need an initial add-on therapy after failure to control seizures with the first or further monotherapy at the optimal dose and duration
Despite antiepileptic drug (AED) treatment within the last 8 weeks, participants must have had greater than or equal to 2 partial onset seizures, and the interval between those seizures should be more than 24 hours prior to Visit 1 (Week 0).
Are currently being treated with stable doses of monotherapy for 8 weeks prior to Visit 1 (Week 0) (Standard AEDs)
If antidepressants or antianxiety drugs are used, participants must be receiving stable doses and administrations of antidepressants or antianxiety drugs for 8 weeks prior to Visit 1 (Week 0)
Exclusion Criteria:
Females who are pregnant (positive beta-human chorionic gonadotropin (β-hCG test) or breastfeeding
Presence of previous history of Lennox-Gastaut syndrome
Presence of nonmotor simple partial seizures only
Presence of primary generalized epilepsies or seizures such as absences and/or myoclonic epilepsies
A history of status epilepticus within 12 weeks before Visit 1 (Week 0)
Participants on antipsychotics or who have psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of attempted suicide within 1 year before Visit 1 (Week 0)
Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
Concomitant use of barbiturates (except for seizure control indication and premedication for electroencephalogram [EEG]) and benzodiazepines (except for seizure control indication) within 8 weeks prior to Visit 1 (Week 0)
Use of intermittent rescue benzodiazepines (that is, 1 to 2 doses over a 24-hr period considered one-time rescue) 2 or more times in an 8-week period prior to Visit 1 (Week 0)
Participant who is participating in other intervention clinical trial
Facility Information:
City
Busan
Country
Korea, Republic of
City
Daegu
Country
Korea, Republic of
City
Daejeon
Country
Korea, Republic of
City
Gwangju
Country
Korea, Republic of
City
Seongnam
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Participants With Partial Onset Seizures With or Without Secondary Generalization
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