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    Summary
    EudraCT Number:2018-002484-25
    Sponsor's Protocol Code Number:TAK-935-2002(OV935)
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-12-11
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-002484-25
    A.3Full title of the trial
    A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TAK-935 (OV935) AS AN ADJUNCTIVE THERAPY IN PEDIATRIC PATIENTS WITH DEVELOPMENTAL AND/OR EPILEPTIC ENCEPHALOPATHIES (ELEKTRA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2, multicenter, randomized, double-blind, controlled with placebo, to obtaine efficacy , safety and tolerability information for TAK-935 as an adjuntive therapy in pediatric patinets ((aged ≥2 and ≤17 years) with developmental and/or epileptic encephlopathies (Dravet syndrome and Lennox Gastaut)
    A.4.1Sponsor's protocol code numberTAK-935-2002(OV935)
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Development Center Americas, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTakeda Development Center Americas, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Development Center Americas, Inc.
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address95 Hayden Avanue
    B.5.3.2Town/ cityLexington, MA
    B.5.3.3Post code02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617444-1422
    B.5.6E-mailDimitros.Arkilo@takeda.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code TAK-935
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNone at this time
    D.3.9.1CAS number 1429505-03-2
    D.3.9.2Current sponsor codeTAK-935
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code TAK-935
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNone at this time
    D.3.9.1CAS number 1429505-03-2
    D.3.9.2Current sponsor codeTAK-935
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Epileptic Encephalitis: Dravet and Lennox Gastuat syndrome (LGS)
    E.1.1.1Medical condition in easily understood language
    Epileptic Encephalitis: Dravet and Lennox Gastuat syndrome (LGS)
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect on the frequency of all seizures (convulsive and drop) in patients treated with TAK-935 as an adjunctive therapy compared to placebo in the Maintenance Period
    E.2.2Secondary objectives of the trial
    Effect on freq. of convulsive and drop seizures in pts treated with TAK-
    935 as adjunctive therapy compared to placebo throughout the
    Treatmeant Period.
    Effect on freq. of convulsive seizure in pts with Dravet Syndrome(DS) treated with TAK-935 as compared to placebo throughout Maintenance Period
    Effect on freq. of drop seizure in patients with LGS treated with TAK-935 compared to placebo in Maintenance Period
    Investigate the seizure freq. of LGS and Dravet pts, patients considered treatment responders throughout the Maintenance Period; treatment responders: Worsening of 25% or more, 1%-25%, no change in drop seizures from baseline(Worsening of 1% to Reduction of 1%);Reduction of: 25% or more, 50% or more, 75% or more, or 100% in drop seizures from baseline.
    Change in CGI-S/C responses of Investigator and Care GI-C assessment in pts treated with TAK-935 compared to placebo
    characterize relationship between plasma 24S-hydroxycholesterol levels and seizure frequency
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient and patient's legal representative (i.e., parent or legal guardian) are willing and able to read, understand, and sign the informed consent form and assent, if applicable
    2. Male and female patients aged ≥2 and ≤17 years at the time of informed consent and the first dose of study drug
    3. Clinical diagnosis of LGS and a history of, on average, ≥4 drop seizures per month during the 3 months immediately prior to Screening based on the historic information, and the patient has ≥4 drop seizures during a minimum of 4 weeks of seizure data collection during the prospective Baseline Period - OR - Clinical diagnosis of Dravet syndrome and a history of, on average, ≥3 convulsive seizures per month during the past 3 months based on the historic information, and the patient has ≥3 convulsive seizures during a minimum of 4 weeks of seizure data collection during the prospective Baseline Period
    4. Weight of ≥10 kg at the Screening visit (Visit 1)
    5. Currently taking 1 to 4 AEDs at a stable dose for 4 weeks prior to the Screening visit (Visit 1); benzodiazepines used chronically (on daily frequency) to treat seizures are considered AEDs
    6. If using a vagal nerve stimulator (VNS), must have VNS placed at least 3 months prior to the Screening visit with stable settings for >1 month; VNS parameters must remain constant throughout the study (VNS will not be counted as an AED)
    7. If on a ketogenic diet, must have started the ketogenic diet at least 3 months prior to the Screening visit (Visit 1), diet should be stable for 4 weeks before the Screening visit (Visit 1); and should continue through the duration of the study (ketogenic diet will not be counted as an AED)
    8. Failed to become and remain seizure free with trials of at least 2 AEDs
    9. The patient and patient's legal representative (i.e., parent or legal guardian) are willing to keep the AED, VNS, and ketogenic diet regimen(s) stable throughout the study
    10. The patient is able to carry out all appropriate assessment and take study drug in the opinion of the Investigator and parent/caregiver
    11. The patient has a documented clinical diagnosis of Dravet syndrome or LGS:
    Diagnosis of Dravet syndrome supported by:
    • Onset of seizures around 6 months of age
    • Initial seizures
    - Fever-induced or fever-triggered seizures
    - Hemiclonic or generalized tonic seizures
    - Prolonged seizures (approximately 15 minutes or longer, some >30 min)
    • Between 1 and 5 years, other seizure types emerge:
    - Myoclonic seizures
    - Focal awareness altered
    - Absence
    - Non-convulsive status (absence or myoclonic)
    - Convulsive status epilepticus
    • Development normal within 1st year of life, then intellectual disability emerges
    - May regress with recurrent status epilepticus
    Diagnosis of Lennox-Gastaut syndrome supported by:
    • History of abnormal EEG consistent with LGS
    - EEG with slow and/or disorganized background AND one of the following:
    o EEG with bursts of generalized 2.5 Hz (or less) spike and wave activity, OR
    o Generalized paroxysmal fast activity (GPFA)
    • Greater than 1 type of generalized seizure for at least 6 months
    - At least 1 seizure type with drop seizures
    • Less than 11 years of age at the onset of LGS
    - Evidence of development delay or regression OR history of special education classed OR measured IQ <70
    12. Sexually active female patients of childbearing potential (defined as first menarche) must agree to use a highly effective method of birth control during the study and for 1 month following the last dose of study drug.
    E.4Principal exclusion criteria
    1. The patient has been admitted to a medical facility and intubated for treatment of status epilepticus 2 or more times in the 3 months immediately prior to the screening visit
    2. Non-epileptic events that cannot be reliably distinguished from epileptic seizures (eg, gastroesophageal reflux, muscle cramps, etc.)
    3. Patients with history of confirmed cataract (untreated with surgery)
    4. Unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease, malignancy including progressive tumors, or other abnormality, which may impact the ability to participate in the study or that may potentially confound the study results. It is the responsibility of the Investigator to assess the clinical significance; however, consultation with the Medical Monitor may be warranted.
    5. Any history of alcohol, opioid, or other drug use disorder, as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), within the 2 years immediately prior to the Screening Visit (Visit 1)
    6. Suicide attempt within the last year, at significant risk of suicide (either in the opinion of the Investigator or defined as ‘yes’ to suicidal ideation question 4 or 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS] at Screening) or appearing suicidal per Investigator judgment.
    7. History of human immunodeficiency virus (HIV) infection (patient who has tested positive for human immunodeficiency virus antibodies (HIV)-
    1/2Ab), or history of active hepatitis B, or active hepatitis C infection. (Note that patients who have been vaccinated against hepatitis B [hepatitis B surface antibody {Ab}-positive] who are negative for other markers of prior hepatitis B infection [eg, negative for hepatitis B Core Ab] are eligible)
    8. Abnormal and clinically significant ECG abnormality at Screening
    a. QT interval with Fridericia’s correction method (QTcF) >450 ms (males) or >470 ms (females), confirmed with one repeat testing, at the Screening visit
    9. Abnormal clinical laboratory test results at the Screening visit that suggest a clinically significant underlying disease that would compromise the well-being of the patient (if the patient has alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] >2.5 × the upper limit of normal [ULN], the Medical Monitor should be consulted)
    10. Participated in a clinical study involving another study drug in the previous month (or 5 half-lives of the study drug, whichever is longer) or currently receiving another study drug
    11. Received TAK-935 in a previous clinical study or as a therapeutic agent
    12. Immediate family members, or in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, child, sibling)
    13. Known hypersensitivity to any component of the TAK-935 formulation
    14. Currently pregnant or breastfeeding or is planning to become pregnant within 90 days of the last dose of study drug
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint
    • Percent change from Baseline in seizure frequency per 28 days (based only on convulsive seizures for the patients in the Dravet syndrome stratum and drop seizures for the patients in the LGS stratum) in patients receiving TAK-935 as compared to placebo during the Maintenance Period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary end point will be assessed throughout the study.
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints
    • Percent change from Baseline in seizure frequency per 28 days (based only on convulsive seizures for the patients in the Dravet syndrome stratum and drop seizures for the patients in the LGS stratum) in patients receiving TAK-935 as compared to placebo during the Treatment Period.
    • Percent change from Baseline in convulsive seizure frequency per 28 days in patients randomized to the Dravet syndrome stratum and receiving TAK-935 as compared to placebo during the Maintenance Period
    • Percent change from Baseline in drop seizure frequency per 28 days in patients randomized to the LGS stratum and receiving TAK-935 as compared to placebo during the Maintenance Period
    • Proportion of patients in the LGS stratum considered treatment responders throughout the Maintenance Period; treatment responders defined as those with:
    - Worsening of 25% or more in drop seizures from baseline
    - Worsening of 1% to 25% in drop seizures from baseline
    - No change in drop seizures from baseline (Worsening of 1% to
    Reduction of 1%)
    - Reduction of 25% or more in drop seizures from baseline
    - Reduction of 50% or more in drop seizures from baseline
    - Reduction of 75% or more in drop seizures from baseline
    - Reduction of 100% in drop seizures from baseline
    • Proportion of patients in the Dravet syndrome stratum considered treatment responders throughout the Maintenance Period; treatment responders are defined as those with:
    - Worsening of 25% or more in convulsive seizures from baseline
    - Worsening of 1% to 25% in convulsive seizures from baseline
    - No change in convulsive seizures from baseline (Worsening of 1% to
    Reduction of 1%)
    - Reduction of 25% or more in convulsive seizures from baseline
    - Reduction of 50% or more in convulsive seizures from baseline
    - Reduction of 75% or more in convulsive seizures from baseline
    - Reduction of 100% in convulsive seizures from baseline
    • Change in CGI-S/C responses of Investigator reported impression of efficacy and tolerability of study drug
    • Change in Care GI-C responses of parent/family reported impression of efficacy and tolerability of study drug
    • To characterize plasma 24HC levels and change in seizure frequency in patients treated with TAK-935 as an adjunctive therapy

    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end points will be assessed throughout the study.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    China
    Israel
    Poland
    Portugal
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    It has been defined as the last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days22
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 126
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 63
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 63
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    pediatric population (≥2 years ≤17 years)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 126
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    TAK-935 may be made available after conclusion of the study to patients who are still receiving and benefitting from study treatment in an OLE study (under a separate protocol; TAK-935-18-001;
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-09
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