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Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Participants With Partial Onset Seizures

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ClinicalTrials.gov Identifier: NCT02726074
Recruitment Status : Completed
First Posted : April 1, 2016
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Korea Inc. )

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).

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Perampanel Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Generalized Seizures
Actual Study Start Date : May 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Perampanel

Arm Intervention/treatment
Experimental: Perampanel 12 mg
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.
Drug: Perampanel
Other Name: E2007




Primary Outcome Measures :
  1. 50% Responder Rate in Total Seizures [ Time Frame: 36 weeks ]
    The 50% responder rate is defined as the number of participants who have at least a 50% reduction in seizure frequency during the Maintenance Period relative to Baseline.


Secondary Outcome Measures :
  1. 75% Responder Rate in Total Seizures [ Time Frame: Baseline; 36 weeks ]
    The 75% responder rate is defined as the number of participants who have at least a 75% reduction in seizure frequency during the Maintenance Period relative to Baseline.

  2. 100% Responder Rate (Seizure Free Rate) in Total Seizures [ Time Frame: Baseline; 36 weeks ]
    The 100% responder rate is defined as the number of participants who have at least a 100% reduction in seizure frequency during the Maintenance Period relative to Baseline.

  3. Percent Change in Total Seizure Frequency in the Titration and Maintenance Periods Relative to Baseline [ Time Frame: Baseline; Week 36 ]
    Percent change from Baseline is calculated as: ([post-Baseline value minus the Baseline value] / Baseline value) * 100.

  4. 50% Responder Rate in Secondarily Generalized Tonic Clonic (GTC) Seizures [ Time Frame: Baseline; 36 weeks ]
    GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain. The 50% responder rate is defined as the number of participants who have at least a 50% reduction in seizure frequency during the Maintenance Period relative to Baseline.

  5. 75% Responder Rate in Secondarily Generalized Tonic Clonic Seizures [ Time Frame: Baseline; 36 weeks ]
    GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain. The 75% responder rate is defined as the number of participants who have at least a 75% reduction in seizure frequency during the Maintenance Period relative to Baseline.

  6. 100% Responder Rate (Seizure Free Rate) in Secondarily Generalized Tonic Clonic Seizures [ Time Frame: Baseline; 36 weeks ]
    GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain. The 100% responder rate is defined as the number of participants who have at least a 100% reduction in seizure frequency during the Maintenance Period relative to Baseline.

  7. Percent Change in Secondarily Generalized Tonic Clonic Seizure Frequency in the Titration and Maintenance Period Relative to Baseline [ Time Frame: Baseline and Week 36 ]
    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 is calculated as: ([post-Baseline value minus the Baseline value] / Baseline value) * 100.

  8. Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 36 weeks ]
    Safety will be assessed by monitoring of AEs, withdrawal from treatment, clinical laboratory evaluations (hematology), and vital signs.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 (ie, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726074


Locations
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Korea, Republic of
Busan, Korea, Republic of
Daegu, Korea, Republic of
Daejeon, Korea, Republic of
Gwangju, Korea, Republic of
Seongnam, Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Eisai Korea Inc.

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Responsible Party: Eisai Korea Inc.
ClinicalTrials.gov Identifier: NCT02726074     History of Changes
Other Study ID Numbers: E2007-M065-412
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: July 2018
Keywords provided by Eisai Inc. ( Eisai Korea Inc. ):
epilepsy
partial-onset seizures
secondarily generalized seizures
Additional relevant MeSH terms:
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Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms