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    Clinical Trial Results:
    An Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients with Refractory Partial Seizures

    Summary
    EudraCT number
    		 2016-004950-14
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    14 May 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jun 2019
    First version publication date
    22 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    E2080-A001-302
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00448539
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Eisai Inc.
    Sponsor organisation address
    155 Tice Boulevard, Woodcliff Lake, United States, 07677
    Public contact
    Eisai Medical Information, Eisai Inc., 1 8882472378, esi_oncmedinfo@eisai.com
    Scientific contact
    Eisai Medical Information, Eisai Inc., 1 8882472378, esi_oncmedinfo@eisai.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 May 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 May 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    14 May 2010
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This was an open-label extension study in adolescent and adult (between 12 and 80 years old) subjects who had completed their participation in Study E2080-A001-301. The main objective of this study was to evaluate the safety and efficacy of long-term administration of rufinamide for the control of epileptic seizures in subjects who had refractory partial seizures despite treatment with a maximum of three approved antiepileptic drugs (AEDs).
    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 Council 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 Council for Harmonisation of Technical Requirements for Registration 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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Mar 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 276
    Country: Number of subjects enrolled
    United States: 10
    Worldwide total number of subjects
    286
    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)
    24
    Adults (18-64 years)
    252
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects who completed double-blind study E2080-A001-301 were allowed to enter in open-label extension study 302. Subjects completed a 12-day Transition Phase in study301 during which they continued to receive rufinamide at the maintenance dose achieved in study301 (Arm1), or transitioned from placebo to 3200 mg/day, beginning at 800 mg/day (Arm2).

    Pre-assignment
    Screening details
    		 Four subjects who intended to enroll from Study 301 to 302 did not enroll and were considered screening failures.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open-label extension study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rufinamide (Rufinamide During Core Study)
    Arm description
    		 Subjects entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400 or 3200 mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400 or 3200 mg/day from the double blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800 mg/day to 2400 or 3200 mg/day. During the open-ended open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all subjects; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rufinamide
    Investigational medicinal product code
    E2080
    Other name
    BANZEL
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).

    Arm title
    		 Rufinamide (Placebo During Core Study)
    Arm description
    		 Subjects entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800 mg/day. Upon starting the extension study, during the 12 to 18 day open-label Titration Phase, subjects receiving 2400 or 3200 mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800 mg/day to 2400 or 3200 mg/day. During the open-ended open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all subjects; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rufinamide
    Investigational medicinal product code
    E2080
    Other name
    BANZEL
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).

    Number of subjects in period 1
    		Rufinamide (Rufinamide During Core Study) Rufinamide (Placebo During Core Study)
    Started
    134
    152
    Completed
    0
    0
    Not completed
    134
    152
         Consent withdrawn by subject
    20
    24
         Physician decision
    67
    54
         Diary non-compliance
    1
    -
         Change of medication
    2
    3
         Adverse event, non-fatal
    9
    26
         Medication non-compliance
    4
    1
         Miscellaneous
    2
    1
         Lost to follow-up
    1
    3
         Lack of efficacy
    27
    40
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rufinamide (Rufinamide During Core Study)
    Reporting group description
    		 Subjects entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400 or 3200 mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400 or 3200 mg/day from the double blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800 mg/day to 2400 or 3200 mg/day. During the open-ended open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all subjects; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).

    Reporting group title
    Rufinamide (Placebo During Core Study)
    Reporting group description
    		 Subjects entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800 mg/day. Upon starting the extension study, during the 12 to 18 day open-label Titration Phase, subjects receiving 2400 or 3200 mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800 mg/day to 2400 or 3200 mg/day. During the open-ended open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all subjects; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).

    Reporting group values
    		 Rufinamide (Rufinamide During Core Study) Rufinamide (Placebo During Core Study) Total
    Number of subjects
    		 134 152 286
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 6 18 24
        Adults (18-64 years)
    		 123 129 252
        From 65-84 years
    		 5 5 10
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 63 80 143
        Male
    		 71 72 143
    Race/Ethnicity, Customized
    Units: Subjects
        Black
    		 7 13 20
        White
    		 115 121 236
        Hispanic
    		 10 11 21
        Native American
    		 0 2 2
        Asian/Pacific Islander
    		 2 2 4
        Other
    		 0 3 3

    End points

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    End points reporting groups
    Reporting group title
    Rufinamide (Rufinamide During Core Study)
    Reporting group description
    		 Subjects entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400 or 3200 mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400 or 3200 mg/day from the double blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800 mg/day to 2400 or 3200 mg/day. During the open-ended open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all subjects; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).

    Reporting group title
    Rufinamide (Placebo During Core Study)
    Reporting group description
    		 Subjects entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800 mg/day. Upon starting the extension study, during the 12 to 18 day open-label Titration Phase, subjects receiving 2400 or 3200 mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800 mg/day to 2400 or 3200 mg/day. During the open-ended open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all subjects; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).

    Primary: Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase

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    End point title
    		 Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase [1]
    End point description
    Seizure data was collected via patient diaries. "OL" refers to "open-label." Intent-to-treat (ITT) population: All subjects who completed titration to open-label medication.
    End point type
    Primary
    End point timeframe
    Baseline, Titration Phase (Days 1 to 18), Maintenance Phase
    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: No Statistcal analyses performed for this end point.
    End point values
    		 Rufinamide (Rufinamide During Core Study) Rufinamide (Placebo During Core Study)
    Number of subjects analysed
    134
    151
    Units: Percent change
    median (full range (min-max))
        OL Titration Phase
    -35.65 (-100 to 1570.7)
    -45.1 (-100 to 518.2)
        OL Maintenance Phase
    -30.95 (-100 to 246.5)
    -31.1 (-100 to 322.4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Rufinamide (Rufinamide During Core Study)
    Reporting group description
    		 Subjects entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400 or 3200 mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400 or 3200 mg/day from the double blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800 mg/day to 2400 or 3200 mg/day. During the open-ended open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all subjects; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).

    Reporting group title
    Rufinamide (Placebo During Core Study)
    Reporting group description
    		 Subjects entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800 mg/day. Upon starting the extension study, during the 12 to 18 day open-label Titration Phase, subjects receiving 2400 or 3200 mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800 mg/day to 2400 or 3200 mg/day. During the open-ended open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all subjects; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).

    Serious adverse events
    		 Rufinamide (Rufinamide During Core Study) Rufinamide (Placebo During Core Study)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    29 / 134 (21.64%)
    23 / 152 (15.13%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leiomyosarcoma
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 134 (0.75%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epileptic psychosis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal behaviour
         subjects affected / exposed
    1 / 134 (0.75%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 134 (0.75%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    White blood cell count decreased
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug toxicity
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shunt malfunction
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    2 / 134 (1.49%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventriculoperitoneal shunt malfunction
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    5 / 134 (3.73%)
    7 / 152 (4.61%)
         occurrences causally related to treatment / all
    1 / 5
    4 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 134 (0.75%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Grand Mal Convulsion
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures with secondary generalisation
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postictal state
         subjects affected / exposed
    0 / 134 (0.00%)
    2 / 152 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    3 / 134 (2.24%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis erosive
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchopneumonia
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 134 (0.00%)
    2 / 152 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal bacteraemia
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection staphylococcal
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Rufinamide (Rufinamide During Core Study) Rufinamide (Placebo During Core Study)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    88 / 134 (65.67%)
    114 / 152 (75.00%)
    Investigations
    Weight decreased
         subjects affected / exposed
    8 / 134 (5.97%)
    9 / 152 (5.92%)
         occurrences all number
    8
    10
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    8 / 134 (5.97%)
    4 / 152 (2.63%)
         occurrences all number
    12
    7
    Fall
         subjects affected / exposed
    7 / 134 (5.22%)
    5 / 152 (3.29%)
         occurrences all number
    13
    7
    Skin laceration
         subjects affected / exposed
    9 / 134 (6.72%)
    5 / 152 (3.29%)
         occurrences all number
    11
    7
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    10 / 134 (7.46%)
    20 / 152 (13.16%)
         occurrences all number
    10
    26
    Coordination Abnormal
         subjects affected / exposed
    4 / 134 (2.99%)
    10 / 152 (6.58%)
         occurrences all number
    5
    13
    Dizziness
         subjects affected / exposed
    11 / 134 (8.21%)
    43 / 152 (28.29%)
         occurrences all number
    16
    65
    Headache
         subjects affected / exposed
    15 / 134 (11.19%)
    17 / 152 (11.18%)
         occurrences all number
    19
    21
    Somnolence
         subjects affected / exposed
    2 / 134 (1.49%)
    14 / 152 (9.21%)
         occurrences all number
    2
    19
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 134 (4.48%)
    15 / 152 (9.87%)
         occurrences all number
    6
    20
    Pyrexia
         subjects affected / exposed
    1 / 134 (0.75%)
    9 / 152 (5.92%)
         occurrences all number
    5
    13
    Eye disorders
    Diplopia
         subjects affected / exposed
    4 / 134 (2.99%)
    10 / 152 (6.58%)
         occurrences all number
    7
    14
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    4 / 134 (2.99%)
    8 / 152 (5.26%)
         occurrences all number
    6
    12
    Diarrhoea
         subjects affected / exposed
    6 / 134 (4.48%)
    9 / 152 (5.92%)
         occurrences all number
    6
    9
    Nausea
         subjects affected / exposed
    12 / 134 (8.96%)
    19 / 152 (12.50%)
         occurrences all number
    12
    24
    Vomiting
         subjects affected / exposed
    14 / 134 (10.45%)
    12 / 152 (7.89%)
         occurrences all number
    15
    14
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 134 (1.49%)
    8 / 152 (5.26%)
         occurrences all number
    2
    12
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    7 / 134 (5.22%)
    6 / 152 (3.95%)
         occurrences all number
    7
    6
    Depression
         subjects affected / exposed
    12 / 134 (8.96%)
    3 / 152 (1.97%)
         occurrences all number
    12
    3
    Insomnia
         subjects affected / exposed
    13 / 134 (9.70%)
    10 / 152 (6.58%)
         occurrences all number
    13
    10
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    10 / 134 (7.46%)
    5 / 152 (3.29%)
         occurrences all number
    13
    5
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    12 / 134 (8.96%)
    8 / 152 (5.26%)
         occurrences all number
    15
    14
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 134 (6.72%)
    6 / 152 (3.95%)
         occurrences all number
    11
    9
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 134 (1.49%)
    11 / 152 (7.24%)
         occurrences all number
    2
    13

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    This study was terminated early by the sponsor due to the discontinuation of clinical development for rufinamide.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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