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    Summary
    EudraCT Number:2008-002062-62
    Sponsor's Protocol Code Number:ALS-TAL-201
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-12-17
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2008-002062-62
    A.3Full title of the trial
    A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS).

    ALS-TAL-201-OL is added as an open label extension of the ALS-TAL-201 trial:
    A Multinational, Multicenter, Open label phase to Assess Tolerability and Safety of Talampanel 50mg tid in Subjects with Amyotrophic Lateral Sclerosis (ALS).
    A.4.1Sponsor's protocol code numberALS-TAL-201
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTeva Pharmaceutical Industries, Ltd
    B.1.3.4CountryIsrael
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.1Product nametalampanel
    D.3.2Product code TV-7110
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNNot available yet
    D.3.9.1CAS number 161832-65-1
    D.3.9.2Current sponsor codeTV-7110
    D.3.9.3Other descriptive nametalampanel
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5 and 25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.3.1Product nametalampanel
    D.3.2Product code TV-7110
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNNot available yet
    D.3.9.1CAS number 161832-65-1
    D.3.9.2Current sponsor codeTV-7110
    D.3.9.3Other descriptive nametalampanel
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5 and 25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboCapsule*
    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
    Amyotrophic lateral sclerosis (ALS).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10052653
    E.1.2Term Amyotrophic lateral sclerosis gene carrier
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ALS-TAL-201: Comparison of primary endpoint between 50 mg tid talampanel and placebo group.

    ALS-TAL-201-OL: OL treatment for all subjects who completed the double blind, placebo-controlled ALS-TAL-201, if investigator and subject consider it to be in subject’s interest to receive talampanel 50mg tid.
    Exploration of long-term safety and tolerability of talampanel 50mg tid.
    E.2.2Secondary objectives of the trial
    Secondary objectives in line with the hierarchy principal acc. the following order:
    1. Comparison of secondary endpoint between the 50 mg tid talampanel and placebo group
    2. Comparison of primary endpoint between the 25 mg tid talampanel and placebo group
    3. Comparison of secondary endpoint between the 25 mg tid talampanel and placebo group
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    All information on the ancillary studies appears in this protocol.

    Pharmacokinetics (PK)
    1. Pharmacokinetic analysis: characterize the pharmacokinetic parameters of talampanel and its N-acetyl metabolite following multiple dosing in ALS patients
    2. Population PK analysis: population pharmacokinetic analysis will be done to assess covariates that affect exposure to talampanel and its N-acetyl metabolite
    3. PK/PD analysis: determine the relationship between exposure to talampanel and the pharmacodynamic response as measured by ALSFRS-R

    Pharmacogenetics
    Collect and store DNA samples for use in genetic analyses. Pharmacogenetic analysis will be performed to investigate the correlation between NAT2 genetic polymorphism with the response to talampanel, including pharmacokinetic, pharmacodynamic, as well as safety parameters. The exploratory of other genetic markers related to the pharmacokinetic route of talampanel (e.g. CYP2C8) or to the drug mode of action might be also analyzed. DNA samples will be stored for 15 years for further pharmacogenetic analyses that might be performed in the future.
    E.3Principal inclusion criteria
    ALS-TAL-201:
    1) Males and females with definite, probable or probable laboratory-supported ALS according to the World Federation of Neurology revised El Escorial criteria. ALS may be familial or sporadic (Appendix 1).
    2) Subjects must be between 18 and 80 years of age (inclusive).
    3) Subjects must have experienced their first ALS symptoms within 3 years inclusive prior to the screening visit.
    4) Subjects must have a Slow VC score equal to or greater than 70% of the predicted value for gender, height and age at the screening and baseline visits.
    5) The sum of the 3 respiratory items from the ALSFRS-R must total at least 10 points at the screening and baseline visits.
    6) Subjects taking riluzole must be on a stable dose for at least 8 weeks prior to the screening visit.
    7) Participants must be able to take oral medication at time of screening and baseline visits.

    ALS-TAL-201-OL:
    Completed 52 wks treatment in ALS-TAL-201 trial.

    ALS-TAL-201 and ALS-TAL-201-OL:
    1) Women must be postmenopausal, surgically sterile, or using adequate birth control methods.
    2) Willingness and ablility to give written IC prior to performing any open-label extension. If the subject is unable to write, he/she may give oral consent or if not possible visual consent (such as head nodding) in the presence of at least one witness as provided in local country legislation.
    E.4Principal exclusion criteria
    ALS-TAL-201:
    1) Use of mechanical ventilation (invasive or non-invasive, including Continuous Positive Airway Pressure (CPAP) for any part of the day or night or Bilevel Positive Airway Pressure (BiPap) for any part of the day prior to the screening visit or baseline.
    2) Feeding tube present at time of screening or baseline.
    3) Any clinically significant or unstable medical or surgical condition including cardiovascular, hepatic, pulmonary, renal, autoimmune, endocrine, metabolic, malignancy or psychiatric or any other condition that, in the investigator's opinion, places the subject at undue risk by participating in the study.
    4) Patients whose mean QTc value calculated from 3 baseline measurements is above 450msec.
    5) Patients with ECG signs of Brugada syndrome and/ or complete or incomplete RBBB (Right Bundle Branch Block) during screening and/ or baseline visits.
    6) Patients with clinical signs and symptoms of dementia.
    7) Known HIV positive.
    8) History of known sensitivity or intolerability to benzodiazepines.
    9) Subjects having used within the specified time prior to screening any of the following:
    - Talampanel (any previous use)
    - Mecasermin (rhIGF-1) (within 4 weeks prior to screening)
    - Chronic use of minocycline (14 consecutive days or more within 4 weeks prior to screening)
    - Chronic use of lithium carbonate use within 4 weeks prior to screening
    - Use of more than 600mg/day coenzyme Q10 (within 4 weeks prior to screening)
    - Any marketed drug, (within 12 weeks prior to screening) if its use was not clearly indicated for any underlying medical condition other than ALS (symptomatic drugs for ALS and supplements allowed)
    - Subjects participating in any other investigational drug trial and use of any other investigational drug within 12 weeks prior to screening
    - Taking any drugs which induce or inhibit talampanel metabolism within 2 weeks prior to screening
    - Taking substrates of CYP2C8 within 2 weeks prior to screening, with the exception of amiodarone and chloroquine that should not be taken within 4 months prior to screening
    10) Addiction to a drug or substance within the past year prior to screening.
    11) Subjects unable at time of the screening and baseline visits to comply with the planned schedule of study visits and study procedures

    ALS-TAL-201-OL:
    1) Subjects with ECG signs of Brugada syndrome and/ or complete or incomplete RBBB (Right Bundle Branch Block)
    2) Subjects using any of the following:
    - Chronic use of lithium carbonate
    - Mecasermin (rhIGF-1)
    - Chronic use of minocycline
    - More than 600mg/day coenzyme Q10
    - Any marketed drug, if its use was not clearly indicated for any underlying medical condition other than ALS (symptomatic drugs for ALS and supplements allowed)
    - Participating in any other IMP study and use of any other IMP
    - Taking any drugs which induce or inhibit talampanel metabolism (Appendix 2)
    - Taking substrates of CYP2C8 (Appendix 2)

    ALS-TAL-201 and ALS-TAL-201-OL:
    1) Females who are pregnant or nursing.
    2) Females of child-bearing potential who do not practice medically acceptable methods of contraception [surgical sterilization, intrauterine device (IUD), hormonal preparations, or double barrier method (e.g. condom or diaphragm, and spermicide)].
    3) Any condition which the investigator feels may interfere with participation.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:
    ALS-TAL-201: Slope of the changes from baseline to each visit in ALSFRS-R score

    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 Yes
    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 Yes
    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.8.3 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Last visit of the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 540
    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)
    See Protocol section 8.3.
    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 Decision2008-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
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