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    Clinical Trial Results:
    A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

    Summary
    EudraCT number
    		 2007-006191-11
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    11 Nov 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 May 2019
    First version publication date
    30 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    E2007-G000-304
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00699972
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Eisai Inc.
    Sponsor organisation address
    300 Tice Boulevard, Woodcliff Lake, United States, 07677
    Public contact
    Eisai Call Center, Eisai Inc., 888 422-4743,
    Scientific contact
    Eisai Call Center, Eisai Inc., 888 422-4743,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000467-PIP01-08
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Nov 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of two doses of perampanel (8 and 12 mg) in comparison to placebo given as adjunctive therapy in subjects with refractory partial seizures.
    Protection of trial subjects
    This study was conducted in accordance with standard operating procedures (SOPs) of the sponsor (or designee), which are designed to ensure adherence to Good Clinical Practice (GCP) guidelines as required by the following: - Principles of the World Medical Association Declaration of Helsinki (World Medical Association, 2008) - International Conference on Harmonisation (ICH) E6 Guideline for GCP (CPMP/ICH/135/95) of the European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products, International Conference on Harmonisation of Pharmaceuticals for Human Use - Title 21 of the United States (US) Code of Federal Regulations (US 21 CFR) regarding clinical studies, including Part 50 and Part 56 concerning informed subject consent and Institutional Review Board (IRB) regulations and applicable sections of US 21 CFR Part 312 - European Good Clinical Practice Directive 2005/28/EC and Clinical Trial Directive 2001/20/EC for studies conducted within any European Union (EU) country. All suspected unexpected serious adverse reactions were reported, as required, to the Competent Authorities of all involved EU member states. - Article 14, Paragraph 3, and Article 80-2 of the Pharmaceutical Affairs Law (Law No. 145, 1960).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Apr 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 100
    Country: Number of subjects enrolled
    Canada: 25
    Country: Number of subjects enrolled
    Chile: 38
    Country: Number of subjects enrolled
    Mexico: 24
    Country: Number of subjects enrolled
    United States: 203
    Worldwide total number of subjects
    390
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    40
    Adults (18-64 years)
    338
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 534 subjects were screened for entry into the study. Of 534 subjects, 147 were screen failures and 387 were eligible to continue in the study. A total of 390 subjects were randomized into the study; 387 who were eligible and 3 who failed screening but were inappropriately randomized (2 received study treatment and 1 did not).

    Pre-assignment
    Screening details
    		 This was a randomized, double-blind, placebo-controlled parallel-group study consisting of three phases: Prerandomization, Double-blind, and Follow-up. Subjects who experienced the required minimum number of seizures during the Prerandomization phase, entered the Double-blind Phase and were randomized to placebo or 8 or 12 mg perampanel groups.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    Placebo tablets were identical in appearance to active drug tablets. All study drugs were packaged and labeled so as to be indistinguishable between treatment groups. A master list of all treatments, and subject numbers associated with them, was maintained in a sealed envelope. If knowledge of a given treatment was required due to an emergency or for regulatory reporting of safety information, the blind would be broken via the code-break facility in the IVRS.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 6 placebo tablets received daily during both Titration and Maintenance Periods.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6 placebo tablets received daily during both Titration and Maintenance Periods.

    Arm title
    		 Perampanel 8 mg
    Arm description
    		 Perampanel 8 mg maximum daily dose (Titration from 2 mg to 8 mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Perampanel
    Investigational medicinal product code
    E2007
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment was administered orally once a day as 4 x 2-mg perampanel tablets plus 2 x placebo tablets before bedtime and with food.

    Arm title
    		 Perampanel 12 mg
    Arm description
    		 Perampanel 12 mg maximum daily dose (Titration from 2 mg to 12 mg daily over 6-weeks; Maintenance at 12 mg daily over 13 weeks).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Perampanel
    Investigational medicinal product code
    E2007
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment was administered orally once a day as 6 x 2-mg perampanel tablets plus 2 x placebo tablets before bedtime and with food.

    Number of subjects in period 1 [1]
    		Placebo Perampanel 8 mg Perampanel 12 mg
    Started
    121
    133
    134
    Completed
    106
    114
    100
    Not completed
    15
    19
    34
         Adverse event, non-fatal
    7
    9
    24
         Administrative/Other
    3
    1
    4
         Inadequate therapeutic effect
    2
    -
    2
         Lost to follow-up
    -
    2
    -
         Subject choice
    3
    7
    4
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects in the Baseline period are those who received the study treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 6 placebo tablets received daily during both Titration and Maintenance Periods.

    Reporting group title
    Perampanel 8 mg
    Reporting group description
    		 Perampanel 8 mg maximum daily dose (Titration from 2 mg to 8 mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks).

    Reporting group title
    Perampanel 12 mg
    Reporting group description
    		 Perampanel 12 mg maximum daily dose (Titration from 2 mg to 12 mg daily over 6-weeks; Maintenance at 12 mg daily over 13 weeks).

    Reporting group values
    		 Placebo Perampanel 8 mg Perampanel 12 mg Total
    Number of subjects
    		 121 133 134 388
    Age categorical
    Safety Population used. One subject in Arm 1 and one subject in Arm 3 were randomized, but not treated.
    Units: Subjects
        <18 years
    		 14 15 10 39
        18-64 years
    		 102 116 119 337
        >64 years
    		 5 2 5 12
    Gender categorical
    Safety Population used. One subject in Arm 1 and one subject in Arm 3 were randomized, but not treated.
    Units: Subjects
        Female
    		 67 68 65 200
        Male
    		 54 65 69 188
    Race/Ethnicity, Customized
    Safety Population used. One subject in Arm 1 and one subject in Arm 3 were randomized, but not treated.
    Units: Subjects
        White
    		 103 115 116 334
        Black or African American
    		 13 6 8 27
        Asian
    		 0 1 1 2
        Chinese
    		 0 1 1 2
        American Indian or Alaska Native
    		 0 4 2 6
        Other
    		 5 6 6 17

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 6 placebo tablets received daily during both Titration and Maintenance Periods.

    Reporting group title
    Perampanel 8 mg
    Reporting group description
    		 Perampanel 8 mg maximum daily dose (Titration from 2 mg to 8 mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks).

    Reporting group title
    Perampanel 12 mg
    Reporting group description
    		 Perampanel 12 mg maximum daily dose (Titration from 2 mg to 12 mg daily over 6-weeks; Maintenance at 12 mg daily over 13 weeks).

    Primary: 50 Percent (%) Responder Rate

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    End point title
    		 50 Percent (%) Responder Rate [1]
    End point description
    A responder was a subject who had a 50 % or greater reduction in seizure frequency per 28 days from the Pre‑randomization phase. Analysis was carried out on the Full Intent-to-Treat (ITT) Analysis Set which included all randomized subjects who received study drug and had any seizure frequency data from the Double-blind Phase- Last Observation Carried Forward (LOCF).
    End point type
    Primary
    End point timeframe
    Baseline (Pre-randomization) through Week 19
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed in the end point.
    End point values
    		 Placebo Perampanel 8 mg Perampanel 12 mg
    Number of subjects analysed
    121
    133
    133
    Units: percentage of subjects
    number (not applicable)
        Yes (Responder)
    26.4
    37.6
    36.1
        No (Non-Responder)
    73.6
    62.4
    63.9
    No statistical analyses for this end point

    Secondary: Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)

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    End point title
    		 Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)
    End point description
    Seizure frequency per 28 days was derived from the information recorded in the subject diaries. Analysis was carried out on the Full ITT Analysis Set.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-randomization) through Week 19
    End point values
    		 Placebo Perampanel 8 mg Perampanel 12 mg
    Number of subjects analysed
    121
    133
    133
    Units: Percent Change in seizure frequency
        median (full range (min-max))
    -20.95 (-100 to 397.5)
    -26.34 (-100 to 150.7)
    -34.49 (-100 to 659.7)
    No statistical analyses for this end point

    Secondary: Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)

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    End point title
    		 Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)
    End point description
    Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries. Analysis was carried out on the Full ITT Analysis Set.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-randomization) through Week 19
    End point values
    		 Placebo Perampanel 8 mg Perampanel 12 mg
    Number of subjects analysed
    110
    120
    120
    Units: Percent Change
        median (full range (min-max))
    -17.88 (-100 to 653.5)
    -33.03 (-100 to 150.7)
    -33.06 (-100 to 1006.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time the subject signed the informed consent form to 30 days after the last dose of the study drug (approximately 2 years and 7 months)
    Adverse event reporting additional description
    Adverse events (AE) were assessed at clinical visits based on the subject's diary, vitals, weight, physical exam, neurological exam, laboratory evaluations; and by telephone interviews/contact. Safety Population used which consists of subjects who were randomized to study drug, received study drug, and had at least one postdose safety assessment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    V. 13.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 6 placebo tablets received daily during both Titration and Maintenance Periods.

    Reporting group title
    Perampanel 12 mg
    Reporting group description
    		 Perampanel 12 mg maximum daily dose (Titration from 2 mg to 12 mg daily over 6-weeks; Maintenance at 12 mg daily over 13-weeks).

    Reporting group title
    Perampanel 8 mg
    Reporting group description
    		 Perampanel 8 mg maximum daily dose (Titration from 2 mg to 8 mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks).

    Serious adverse events
    		 Placebo Perampanel 12 mg Perampanel 8 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 121 (4.96%)
    9 / 134 (6.72%)
    8 / 133 (6.02%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 134 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 134 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple drug overdose intentional
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 134 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 134 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 134 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 134 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Skin graft
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 134 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Grand mal convulsion
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 134 (0.75%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 134 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 134 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 134 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 134 (1.49%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 134 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Omental infarction
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 134 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 134 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Adjustment disorder
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 134 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aggression
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 134 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Conversion disorder
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 134 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Disorientation
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 134 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impulse-control disorder
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 134 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 134 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 134 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 134 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 134 (0.00%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 134 (0.00%)
    1 / 133 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Wound infection staphylococcal
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 134 (0.00%)
    2 / 133 (1.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 134 (0.75%)
    0 / 133 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Perampanel 12 mg Perampanel 8 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    71 / 121 (58.68%)
    98 / 134 (73.13%)
    101 / 133 (75.94%)
    Investigations
    Weight increased
         subjects affected / exposed
    1 / 121 (0.83%)
    4 / 134 (2.99%)
    8 / 133 (6.02%)
         occurrences all number
    1
    5
    8
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    8 / 121 (6.61%)
    16 / 134 (11.94%)
    13 / 133 (9.77%)
         occurrences all number
    10
    19
    20
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    0 / 121 (0.00%)
    16 / 134 (11.94%)
    8 / 133 (6.02%)
         occurrences all number
    0
    18
    9
    Balance disorder
         subjects affected / exposed
    1 / 121 (0.83%)
    5 / 134 (3.73%)
    10 / 133 (7.52%)
         occurrences all number
    1
    6
    11
    Dizziness
         subjects affected / exposed
    12 / 121 (9.92%)
    51 / 134 (38.06%)
    50 / 133 (37.59%)
         occurrences all number
    15
    86
    74
    Headache
         subjects affected / exposed
    16 / 121 (13.22%)
    18 / 134 (13.43%)
    20 / 133 (15.04%)
         occurrences all number
    29
    27
    39
    Somnolence
         subjects affected / exposed
    16 / 121 (13.22%)
    23 / 134 (17.16%)
    24 / 133 (18.05%)
         occurrences all number
    18
    26
    27
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 121 (4.13%)
    11 / 134 (8.21%)
    10 / 133 (7.52%)
         occurrences all number
    5
    11
    22
    Irritability
         subjects affected / exposed
    6 / 121 (4.96%)
    19 / 134 (14.18%)
    10 / 133 (7.52%)
         occurrences all number
    6
    23
    10
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 121 (0.00%)
    7 / 134 (5.22%)
    4 / 133 (3.01%)
         occurrences all number
    0
    14
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 121 (6.61%)
    6 / 134 (4.48%)
    9 / 133 (6.77%)
         occurrences all number
    11
    18
    9
    Nausea
         subjects affected / exposed
    8 / 121 (6.61%)
    8 / 134 (5.97%)
    9 / 133 (6.77%)
         occurrences all number
    9
    8
    12
    Vomiting
         subjects affected / exposed
    5 / 121 (4.13%)
    7 / 134 (5.22%)
    4 / 133 (3.01%)
         occurrences all number
    5
    7
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 121 (2.48%)
    8 / 134 (5.97%)
    6 / 133 (4.51%)
         occurrences all number
    3
    8
    7
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    3 / 121 (2.48%)
    7 / 134 (5.22%)
    7 / 133 (5.26%)
         occurrences all number
    3
    9
    7
    Insomnia
         subjects affected / exposed
    6 / 121 (4.96%)
    8 / 134 (5.97%)
    8 / 133 (6.02%)
         occurrences all number
    7
    8
    9
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    3 / 121 (2.48%)
    7 / 134 (5.22%)
    2 / 133 (1.50%)
         occurrences all number
    3
    7
    2
    Infections and infestations
    Influenza
         subjects affected / exposed
    8 / 121 (6.61%)
    4 / 134 (2.99%)
    6 / 133 (4.51%)
         occurrences all number
    11
    6
    6
    Nasopharyngitis
         subjects affected / exposed
    6 / 121 (4.96%)
    6 / 134 (4.48%)
    10 / 133 (7.52%)
         occurrences all number
    6
    7
    13

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Mar 2009
    In addition to minor administrative changes, the amendment made the following changes to the protocol: • Added evaluations of photosensitivity, withdrawal symptoms, pharmacogenomics tests as exploratory objectives, and added the photosensitivity and withdrawal questionnaires to the list of safety parameters to be evaluated • Clarified that QT interval was to be corrected (QTc) and specified that the QTc to be reported to the investigator by the central ECG laboratory would be QTcB • Defined the end of the study as the date of database lock to ensure that all data were collected, verified, and cleaned thoroughly following the last subject visit • Deleted text that advised subjects to minimize their exposure to sunlight and added text advising subjects who experienced light-related skin changes to discuss them with their doctor • Clarified how the urine drug screen results were to be used by the investigator • Specified that the investigator should review the subject diary with the subject at Visits 1 and 2 to ensure correct seizure classification • Included specific information about safety monitoring via the DMC • Clarified that urine microscopy was only to be performed as an unscheduled retest at the discretion of the investigator In addition, a letter sent on 8 Jan 2009 instructed all study sites to record all secondarily generalized seizures (simple or complex) under the “complex partial with secondarily generalized seizures” module in the CRFs, to comply with International League Against Epilepsy guidelines for data completeness.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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