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    The EU Clinical Trials Register currently displays   43207   clinical trials with a EudraCT protocol, of which   7151   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-002099-15
    Sponsor's Protocol Code Number:APOCT-001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-08-01
    Trial 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 ConcernedSweden - MPA
    A.2EudraCT number2012-002099-15
    A.3Full title of the trial
    A randomised, double blind, placebo controlled trial to evaluate the safety and efficacy of Apovir for treatment of patients with Amyotrophic lateral sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Apovir for treatment of patients with ALS (Amyotrophic lateral sclerosis)
    Säkerhet och effekt av Apovir vid behandling av patienter med ALS (Amyotrofisk lateralskleros)
    A.4.1Sponsor's protocol code numberAPOCT-001
    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 SponsorApodemus AB
    B.1.3.4CountrySweden
    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 supportApodemus AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationApodemus AB
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressNobels väg 3
    B.5.3.2Town/ citySolna
    B.5.3.3Post code171 65
    B.5.3.4CountrySweden
    B.5.4Telephone number468619 7171
    B.5.5Fax number468619 7181
    B.5.6E-mailbo.niklasson@apodemus.se
    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 namePleconaril
    D.3.2Product code APO-P001
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNPLECONARIL
    D.3.9.1CAS number 153168-05-9
    D.3.9.2Current sponsor codeAPO-P001
    D.3.9.4EV Substance CodeSUB09957MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Yes
    D.2.1.1.1Trade name Copegus
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameRibavirin
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 36791-04-5
    D.3.9.3Other descriptive nameRIBAVIRIN
    D.3.9.4EV Substance CodeSUB10297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboCapsule, hard
    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 placeboCapsule, hard
    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)
    Amyotrofisk lateralskleros (ALS)
    E.1.1.1Medical condition in easily understood language
    A progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord further affecting motor neurons. Motor neurons die leading to loss of muscle control and function.
    En progressiv neurodegenerativ sjukdom som påverkar nervceller i hjärna och ryggmärg som vidare påverkar motorneuron. Motorneuronen dör vilket leder till förlust av muskelkontroll och muskelfunktion.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    SAFETY OBJECTIVE
    To investigate the safety and tolerability of the combination therapy of Apovir in patients with ALS

    PRIMARY EFFICACY OBJECTIVE
    To investigate the effect of Apovir on 12-months disease progression of ALS as assessed by ALSFRS-R score from baseline compared to placebo

    E.2.2Secondary objectives of the trial
    SECONDARY EFFICACY OBJECTIVES
    To investigate the effect of Apovir on disease progression of ALS assessed by ALSFRS-R score at the 4-weeks, 3-, 6-, 9-months, and Follow-up visits, and forced vital capacity (FVC), vital capacity (VC) and maximal voluntary ventilation (MVV) at the 4-weeks, 3-, 6-, 9-, 12-months, and Follow-up visits

    To investigate the combined effect of Apovir on ALSFRS-R, and death or the use of definitive life supporting breathing assistance and death as assessed by Combined assessment of function and survival (CAFS) at the 4-weeks, 3-, 6-, 9-, 12-months, and follow-up visits

    To investigate the effect of Apovir on time from onset of ALS symptoms to the use of definitive life supporting breathing assistance, or Death

    To investigate the plasma concentrations of Apovir in patients with ALS

    Refer to the protocol for further secondary objectives.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female study subjects fulfilling the probable or higher criteria for ALS according to the revised El-Escorial criteria
    2. First documented symptom of ALS ≤ 24 months before screening
    3. The sum of the 3 respiratory items on the ALSFRS-R, 10: dyspnoea, 11: orthopnoea and 12: respiratory insufficiency, must total at least 10 points
    4. Ability to walk without other walking aids than a crutch
    5. 18 – 80 years at the time of screening
    6. FEV% ≥70%
    7. Study subjects with or without pharmacological treatment, i.e. Riluzole for ALS (study subjects with ongoing pharmacological treatment for ALS shall have received unchanged treatment as regards drug(s) and dose(s) for at least 1 month)
    E.4Principal exclusion criteria
    1. Women in fertile age with a positive pregnancy blood test, or planning to become pregnant during the period of the trial. Fertile women include any female who has experienced menarche, who has not undergone tubal ligation, and who is not postmenopausal. Postmenopausal is defined as amenorrhea ≥ 12 consecutive months without another cause
    2. Sexually active men and women without highly effective contraceptive treatment, e.g. sterilisation, condoms and diaphragms with spermicide; oral contraceptives (including Progesterone-only pills in high dose) in combination with a barrier method; hormonal contraceptives alone are not sufficient
    3. Active hepatitis B, active hepatitis C, or HIV infection
    4. Serious cardiac disease including unstable or uncontrolled cardiac disease during the last 6 months and/or a previous history or present clinical signs of deep venous thrombosis
    5. Major surgical procedure within 4 weeks prior to start of treatment
    6. Participation in any other clinical trial within 30 days of inclusion (randomisation) in the trial or patients with unresolved investigational treatment-related adverse events
    7. Other chronic disease or previous organ transplantation judged by the Investigator to interfere with the assessment of treatment success and/or ability to fully participate in the trial
    8. Impaired kidney function with an absolute GFR calculated from cystatin C <60 mL/min
    9. Known blood disease or Anaemia Haemoglobin <120 g/L for women and <130 g/L for men
    10. Known haemoglobinopathy (e.g. thalassemia and sickle cell anaemia)
    11. Patients that require immunosuppressive treatments including azathioprine, cyclosporine, systemic steroid treatment (e.g. prednisolone at doses of ≥10 mg/day or hydrocortisone) or has received such treatment within the last 6 months prior to randomization
    12. Patients that are treated with drugs that can interact significantly with APO-P001; ethinylestradiol and/or ribavirin; azathioprine, didanosine, zidovudine, mercaptopurine, stavudine
    13. Lack of suitability for participation in the trial, for any reason, as judged by the Investigator
    14. Patients with clinical or other signs of frontal temporal lobe dementia (FTLD) or known heredity for FTLD
    E.5 End points
    E.5.1Primary end point(s)
    Primary Safety Endpoint
    • Frequency and intensity of adverse events

    Primary efficacy Endpoints
    • Change in ALSFRS-R from baseline to 12 months using mean change of slope


    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Safety Endpoint
    Evaluations will be analysed throughout the whole CT.

    Primary efficacy Endpoints
    12 months
    E.5.2Secondary end point(s)
    Change in disease progression of ALS as assessed by:
    • Change in ALSFRS-R score from baseline to the 4-weeks, 3-, 6-, 9-, 12-months, and Follow-up visits
    • Change in FVC, VC and MVV from baseline to the 4-weeks, 3-, 6-, 9-, 12-months, and Follow-up visits
    • Change in CAFS from baseline to the 4-weeks, 3-, 6-, 9-, 12-months, and Follow-up visits
    • Time from study inclusion and time of ALS symptoms onset to the use of definitive life supporting breathing assistance, or Death

    Plasma concentrations of Apovir:
    • Plasma concentrations Cpre dose of Apovir at the 4-weeks, 3-, 6-, and 12-months visits. Concentrations at 3 months will be compared to published data [Rhodes and Liu 2001 ; Khakoo et al 1998 ].
    E.5.2.1Timepoint(s) of evaluation of this end point
    Refer to section 5.2
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    The randomisation will be stratified by presence/absence of treatment with Riluzole at baseline.
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state40
    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)
    Continuation of treatment will not be offered.
    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 Decision2014-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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