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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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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.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


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    Summary
    EudraCT Number:2014-004567-21
    Sponsor's Protocol Code Number:3119001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-04
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-004567-21
    A.3Full title of the trial
    Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3-period, multicentre study with open-label follow-up extension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of ODM-109 on respiratory function in patients with ALS.
    A.3.2Name or abbreviated title of the trial where available
    LEVALS
    A.4.1Sponsor's protocol code number3119001
    A.5.4Other Identifiers
    Name:protocol amendmentNumber:Amendment 4
    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 SponsorOrion Corporation Orion Pharma
    B.1.3.4CountryFinland
    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 supportOrion Corporation Orion Pharma
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOrion Corporation Orion Pharma
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressOrionintie 1
    B.5.3.2Town/ cityEspoo
    B.5.3.3Post codeFI-02200
    B.5.3.4CountryFinland
    B.5.6E-mailclinicaltrials@orionpharma.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.3.1Product nameODM-109 capsule 1 mg
    D.3.4Pharmaceutical form Capsule
    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 INNLEVOSIMENDAN
    D.3.9.1CAS number 141505-33-1
    D.3.9.2Current sponsor codeODM-109
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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
    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). A rapidly progressive neurological disease characterized by degeneration of upper and lower motor neurons with subsequent muscle atrophy and weakness and loss of respiratory function. The latter is due to the weakness and loss of the diaphragm muscle strength.
    E.1.1.1Medical condition in easily understood language
    ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and spine. ALS causes these nerve cells to degenerate and die. This prevents the Brain from controlling muscles.
    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 18.1
    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
    The primary objective of the study is to investigate the efficacy of oral levosimendan on respiratory function in patients with Amyotrophic Lateral Sclerosis.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the effect of oral levosimendan (IMP) on:

    1- Hand grip strength
    2- Hand grip endurance
    3- patient quality of life
    4- patient daily functions

    The study will also collect data on safety and tolerability of the IMP.

    The study will evaluate the concentrations of the IMP, and the substances that the human body naturally forms to metabolize the IMP (metabolites), in the blood stream.

    The study will also examine how the presence of these naturally formed metabolites impact on study endpoints.

    The study will also examine the effects of the IMP on another commercially available drug, called Riluzole. All enrolled patients, who are on riluzole, are required to be on a stable Riluzole dose at the time of enrollment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent (IC) for participation in the study will be obtained from the subject (or from the subject’s next of kin, caregiver, or other legally acceptable representative in case the study subject him/herself cannot sign the IC due to severe muscle weakness).

    2. Age of at least 18 years.

    3. Male or female subjects with diagnosis of laboratory supported probable, probable or definite Amyotrophic Lateral Sclerosis (ALS) according to El Escorial revised criteria (Brooks BR et al., 2000). Full electromyogram report available consistent with ALS (but not necessarily fulfilling electrodiagnostic criteria for ALS) according to an experienced neurophysiologist.

    4. Ability to swallow the study treatment capsules.

    5. An upright (sitting position) Slow Vital Capacity between 60-90% of the predicted value for age, height and sex at screening visit.

    6. Normal oxygen saturation during daytime (measure of ≥ 95% when steady state has been reached with a reliable read) in sitting position measured by pulse oximetry.

    7. Disease duration from symptom onset. This is defined by first muscle weakness or difficulty speaking (dysarthria) of 12-48 months at the time of baseline/day 1 of the first treatment period.

    8. Patients ith or without riluzole. If using riluzole, the dose must have been stable for at least 4 weeks prior to screening and should not be cahnged during the cross-over, double blind part of the study.
    E.4Principal exclusion criteria
    1. Subject in whom other causes of neuromuscular weakness have not been excluded.

    2. Subject with a diagnosis of another neurodegenerative disease

    3. Assisted ventilation or gastrostomy of any type during the preceding 3 months prior to screening or predicted to be required within the randomised, double-blind cross-over part of the study

    4. Recorded diagnosis or evidence of major psychiatric diagnosis, significant cognitive impairment or clinically evident dementia

    5. Haemodynamically significant uncorrected valve disease or hypertrophic cardiomyopathy or restrictive cardiomyopathy

    6. Acute myocardial infarction or any other acute coronary event within 1 month before the screening visit

    7. Any major surgery within 1 month before the screening visit or patients who are scheduled for any major surgery during the planned study period

    8. History of Torsades de Pointes, family history of long QT-syndrome or history of life-threatening ventricular arrhythmia within 3 months before screening

    9. Heart Rate of less that 50 or greater than 100 beats per minute as an average over the 24-hour ambulatory Holter-ECG recording at screening

    10. Systolic blood pressure (SBP) less than 100 mmHg or greater than 180 mmHg, or diastolic blood pressure (DBP) greater than 100 mmHg at screening.

    11. Ventricular tachycardia (wide complex tachycardia greater than 100/min, greater than 5 consecutive beats) in the 24-hour ambulatory Holter-ECG recording at screening.

    12. Episode of atrial fibrillation or atrial flutter lasting greater than 60 seconds in 24-hour ambulatory Holter-ECG recording at screening.

    13. Second or third degree atrioventricular (AV) block in the 12-lead ECG or in the 24-hour ambulatory Holter-ECG recording at screening.

    14. Potassium less than 3.7 mmol/l or greater than 5.5 mmol/l at screening

    15. Creatinine greater than 170 µmol/l at screening or on dialysis.

    16. Blood haemoglobin less than 10 g/dl at screening.

    17. Clinically significant hepatic impairment at the discretion of the investigator.

    18. Women of reproductive age without a negative pregnancy test and without a commitment to using an acceptable method of barrier or hormonal contraception (e.g. condoms, diaphragms, oral contraceptives and long acting progestin agents), if sexually active during the study, and for 1 month after the last dose of the study treatment. Women who are postmenopausal (1 year since last menstrual cycle), surgically sterilised or who have undergone a hysterectomy are considered not to be reproductive and can be included.

    19. Known hypersensitivity to levosimendan.

    20. Administration of levosimendan within 30 days prior to screening visit.

    21. Any botulinum toxin use within 3 months from screening. Use of botulinum toxin is not allowed during double bind, cross-over part of the study.

    22. Patients with known history of human immunodeficiency virus (HIV) infection.

    23. Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator could interfere with the interpretation of the study results or constitute a health risk for the subject if he/she took part in the study.

    24. Blood donation or loss of significant amount of blood within 60 days prior to screening.

    25. Participation in a clinical trial with any experimental treatment within 30 days prior to the screening visit or previous participation in the present study.

    26. Any other condition that in the opinion of the investigator could interfere with the interpretation of the study results or constitute a health risk for the subject if they took part in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the seated slow vital capacity (SVC) as defined as the change from baseline to the day 14 predose assessment in terms of the SVC% compared to the predicted value for age, height and sex.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary objectives of the study are to evaluate the efficacy endpoints during the double-blind cross-over part of the study. Efficacy assessments may be repeated throughout the study, however the assessment performed on day 14, pre-dose will be considered primary. The efficacy data assessed on other time points and during the open-label follow-up part will be considered supportive. All efficacy endpoints from both parts of the study will be listed and summarised by treatment groups using appropriate descriptive statistics.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:

    1) Respiratory function
    1.1 SNP
    1.2 Overnight SpO2
    1.3 SVC (supine)

    2) Muscle strength
    2.1 Maximal hand grip strength
    2.2 Submaximal hand grip endurance

    3) Subject reported outcomes
    3.1 Subjects’ assessment of CGI-C
    3.2 Investigators’ assessment of CGI-C
    3.3 Subjects’ assessment of fatigue (VAS)

    4) Quality of life
    4.1 EQ-5D-5L
    4.2 SF-36 Acute form
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy endpoints will be evaluated primarily at the end of double-blind cross-over part.
    Efficacy assessments may be repeated throughout the study for the secondary endpoint, however the assessment performed on day 14, pre-dose will be considered primary for analysis. The efficacy data assessed on other time points and from the open-label follow-up will be considered supportive.
    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 No
    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 Yes
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 No
    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
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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)
    Following the conclusion of the study, patients will revert to their standard of care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-04
    P. End of Trial
    P.End of Trial StatusCompleted
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