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A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures

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ClinicalTrials.gov Identifier: NCT01618695
Recruitment Status : Completed
First Posted : June 13, 2012
Results First Posted : June 5, 2020
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Tracking Information
First Submitted Date  ICMJE June 11, 2012
First Posted Date  ICMJE June 13, 2012
Results First Submitted Date  ICMJE May 20, 2020
Results First Posted Date  ICMJE June 5, 2020
Last Update Posted Date July 15, 2020
Actual Study Start Date  ICMJE May 15, 2012
Actual Primary Completion Date September 15, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2020)
Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline) [ Time Frame: Baseline, Week 19 ]
Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. All partial seizure included simple partial seizures without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalized seizures. A simple partial seizure takes place on one side of the brain. Usually, people experiencing a simple partial seizure do not lose consciousness or awareness. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain. The seizure affects people's awareness and may cause them to lose consciousness.
Original Primary Outcome Measures  ICMJE
 (submitted: June 12, 2012)
The percent change in seizure frequency per 28 days in the Randomization Phase relative to the Prerandomization Phase [ Time Frame: 19 weeks ]
The primary effiacy endpoint will be the percent change in seizure frequency per 28 days in the Randomization Phase relative to the Prerandomization Phase in the ITT ANalysis Set.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2020)
  • Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF) [ Time Frame: Baseline, Week 19 ]
    Responder rate was percentage of participants with greater than or equal to (>=) 50% reduction in seizure frequency during maintenance period of the randomization phase relative to prerandomization phase (baseline). If the reduction in seizure frequency is less than (<) 50%, then the participants are considered as non-responders.
  • Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline) [ Time Frame: Baseline, Week 19 ]
    Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain and it affects awareness and may cause in loss of consciousness. Secondary generalized seizures begin in one part of the brain, but then spread to both sides of the brain.
  • Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores [ Time Frame: Baseline, Week 19 ]
    The investigator evaluated each participant for CGIC questionnaire to assess change in participant's disease clinical status from baseline. Assessment evaluated frequency of seizures, severity of seizures, occurrence of adverse events, and overall functional status of the participant using the 7-point scale. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Lower score indicated improvement. Higher score indicated worsening.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
Official Title  ICMJE A Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
Brief Summary The purpose of this study is to confirm the efficacy and safety of perampanel compared to placebo in patients with refractory partial-onset seizures
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Partial-onset Seizures
Intervention  ICMJE
  • Drug: Perampanel

    Core study: 4 milligram (mg) group- Week 0 Once daily 2 milligram per day (mg/day), Week 1 to Week 18 Once daily 4 mg/day; 8 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 to Week 18 Once daily 8 mg/day; 12 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 Once daily 8 mg/day, Week 4 Once daily 10 mg/day, Week 5 to Week 18 Once daily 12 mg/day.

    Extension study: 4 mg group- Week 19 to Week 22 Once daily 4 mg/day, Week 23 Once daily 6 mg/day, Week 24 Once daily 8 mg/day, Week 25 Once daily 10 mg/day, Week 26 to Week 75 or more Once daily 12 mg/day; 8 mg group- Week 19 to Week 22 Once daily 8 mg/day, Week 23 Once daily 10 mg/day, Week 24 to Week 75 or more Once daily 12 mg/day; 12 mg group- Week 19 to Week 75 or more Once daily 12 mg/day.

    Other Name: E2007
  • Drug: Placebo

    Core study: Week 0 to Week 18 Once daily placebo.

    Extension study:

    Week 19 to Week 22 Once daily placebo, Week 23 Once daily perampanel 2 mg/day, Week 24 Once daily perampanel 4 mg/day, Week 25 Once daily perampanel 6 mg/day, Week 26 Once daily perampanel 8 mg/day, Week 27 Once daily perampanel 10 mg/day, Week 28 to Week 75 or more Once daily perampanel 12 mg/day.

Study Arms  ICMJE
  • Experimental: Perampanel
    Intervention: Drug: Perampanel
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Nishida T, Lee SK, Inoue Y, Saeki K, Ishikawa K, Kaneko S. Adjunctive perampanel in partial-onset seizures: Asia-Pacific, randomized phase III study. Acta Neurol Scand. 2018 Apr;137(4):392-399. doi: 10.1111/ane.12883. Epub 2017 Dec 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2020)
940
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2012)
680
Actual Study Completion Date  ICMJE May 28, 2020
Actual Primary Completion Date September 15, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Male or female and greater than or equal to 12 years of age;
  2. Have a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures
  3. Participants with computed tomography (CT) or magnetic resonance imaging (MRI) diagnosis within the last 10 years (for adults) and 5 years (for adolescents) prior to visit 1 that ruled out progressive central nervous system (CNS) disorders, example, neurodegenerative disorders, brain tumors. For participants without existing CT or MRI results, CT or MRI was performed at or after Visit 1 but results evaluation was performed by Visit 2
  4. Participants who had been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard antiepileptic drug (AED) for 2 years before enrollment
  5. During the 6-week Prerandomization Phase participants must have had greater than or equal to 5 partial seizures per 6-week
  6. Are currently being treated with stable doses and administrations of 1, 2, or a maximum of 3 approved AEDs. Only 1 inducer AED (defined as carbamazepine, phenytoin or oxcarbazepine only) out of the maximum of 3 AEDs is allowed

Exclusion Criteria

  1. Presence of nonmotor simple partial seizures only;
  2. Presence of primary generalized epilepsies or seizures, such as absences and/or myoclonic epilepsies;
  3. Presence or previous history of Lennox-Gastaut syndrome;
  4. A history of status epilepticus within 1 year prior to screening
  5. Seizure clusters where individual seizures cannot be counted
  6. A history of psychogenic seizures within 5 years prior to screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   China,   Japan,   Korea, Republic of,   Malaysia,   Taiwan,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01618695
Other Study ID Numbers  ICMJE E2007-J000-335
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc. ( Eisai Co., Ltd. )
Study Sponsor  ICMJE Eisai Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eisai Inc.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP