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    Summary
    EudraCT Number:2011-004482-32
    Sponsor's Protocol Code Number:RAS-ALS
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-21
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-004482-32
    A.3Full title of the trial
    Efficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients with Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole)
    Studie zur Wirksamkeit, Sicherheit und Verträglichkeit von 1 mg Rasagilin bei Patienten mit Amyotropher Lateralsklerose (ALS) unter Standardtherapie Riluzol
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients with Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole)
    Studie zur Wirksamkeit, Sicherheit und Verträglichkeit von 1 mg Rasagilin bei Patienten mit Amyotropher Lateralsklerose (ALS) unter Standardtherapie Riluzol
    A.3.2Name or abbreviated title of the trial where available
    RAS-ALS Trial
    RAS-ALS Studie
    A.4.1Sponsor's protocol code numberRAS-ALS
    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 SponsorUniversitätsklinikum Ulm
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTEVA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Ulm
    B.5.2Functional name of contact pointProf. Dr. A.C. Ludolph
    B.5.3 Address:
    B.5.3.1Street AddressAlbert-Einstein-Allee 29
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89081
    B.5.3.4CountryGermany
    B.5.4Telephone number004907311771200
    B.5.5Fax number004907311771202
    B.5.6E-mailalbert.ludolph@rku.de
    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 Yes
    D.2.1.1.1Trade name AZILECT® 1 mg Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Tablet
    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 INNRasagiline Mesilate
    D.3.9.1CAS number 161735-79-1
    D.3.9.3Other descriptive nameRASAGILINE MESILATE
    D.3.9.4EV Substance CodeSUB21334
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    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)
    Amyotrophe Lateralsklerose (ALS)
    E.1.1.1Medical condition in easily understood language
    Amyotrophic Lateral Sclerosis (ALS)
    Amyotrophe Lateralsklerose (ALS)
    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 14.1
    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
    Efficacy of rasagiline as add-on therapy to standard therapy with riluzole in patients with ALS compared to placebo in terms of survival (mortality exclusively defined as death).
    Wirksamkeit von Rasagilin als Zusatz zur Standardtherapie mit Riluzol bei Patienten mit ALS im Vergleich zu Placebo im Hinblick auf das Gesamtüberleben (Zeit bis zum Tod)
    E.2.2Secondary objectives of the trial
    1. The change of total score of ALS Functional Rating Scale – Revised (ALSFRS-R)
    2. The change in individual Quality of Life (SEIQoL, Schedule for the Evaluation of Individual Quality of Life)
    3. The change of the slow vital capacity (sVC)
    1. Veränderungen im Gesamtscore des ALS Functional Rating Scale - Revised (ALSFRS-R)
    2. Veränderungen der individuellen Lebensqualität (Quality of Life, SEIQoL, Schedule for the Evaluation of Individual Quality of Life)
    3. Veränderungen der Vitalkapazität (slow vital capacity, sVC)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Possible, probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria
    2. Disease duration more than 6 months and less than 3 years (inclusive). Disease onset defined as date of first muscle weakness, excluding fasciculations and cramps
    3. Vital capacity more than 50% of normal (slow vital capacity; best of three measurements)
    4. Age: ≥ 18 years
    5. Continuously treated with 100 mg riluzole for at least four weeks
    6. Capable of thoroughly understanding all information given and giving full informed consent according to GCP
    7. Women of childbearing age must be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test
    1. Mögliche, wahrscheinliche (klinisch oder laborunterstützt) oder definitive ALS gemäß der revidierten Version der El Escorial World Federation of Neurology Kriterien
    2. Dauer der Erkrankung mehr als 6 Monate und weniger als 3 Jahre (inklusive). Der Krankheitsbeginn ist definiert als Tag der ersten Muskelschwäche, ohne Faszikulationen und Krämpfe
    3. Vitalkapazität mehr als 50% des Normalwertes (slow vital capacity; die beste von 3 Messungen)
    4. Alter: ≥ 18 Jahre
    5. Kontinuierliche Behandlung mit 100 mg Riluzol für mindestens 4 Wochen
    6. Der Prüfungsteilnehmer ist in der Lage, Art, Umfang und individuelle Konsequenzen der klinischen Prüfung zu verstehen und sein Einverständnis gemäß GCP zu erteilen
    7. Frauen im gebärfähigen Alter dürfen nicht stillen und müssen entweder operativ sterilisiert sein oder hochwirksame Verhütungsmethoden anwenden, sowie einen negativen Schwangerschaftstest haben
    E.4Principal exclusion criteria
    1. Previous participation in another clinical study within the preceding 12 weeks
    2. Tracheostomy or assisted ventilation of any type during the preceding three months
    3. Gastrostomy
    4. Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
    5. Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
    6. Patients on sympathomimetic agents, including pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine
    7. Patients on analgesics with serotoninergic properties such as meperidine, tramadol, methadone and propoxyphen
    8. Patients on serotonin reuptake inhibitors (SSRIs),including fluoxetine or fluvoxamine
    9. Patients on dextromethorphan, St. John’s wort, cyclobenzaprine or other MAO inhibitors (selective or non-selective)
    10. Patients taking antidepressants
    11. Confirmed hepatic insufficiency or abnormal liver function (ASAT and/or ALAT greater than 3 times the upper limit of the normal range)
    12. Renal insufficiency (serum creatinine more than 2.26 mg/dL)
    13. Evidence of major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms
    14. Known hypersensitivity to any component of the study drug
    15. Liable to be not cooperative or comply with the trial requirements (as assessed by the investigator), or unable to be reached in the case of emergency
    16. Female with childbearing potential, if no adequate contraceptive measures are used
    17. Pregnancy or breast-feeding females
    1. Teilnahme an einer anderen klinischen Studie innerhalb der letzten 12 Wochen
    2. Tracheostomie oder Beatmungsunterstützung jeglicher Art während der letzten 3 Monate
    3. Gastrostomie
    4. Jede Erkrankung die mit einer Dysfunktion der Motoneurone in Verbindung steht und somit die ALS Diagnose beeinflussen oder erschweren könnte
    5. Jede andere begleitende lebensbedrohliche Erkrankung oder Behinderung, die Einfluss auf die funktionelle Beurteilung des Patienten haben könnte
    6. Einnahme von Sympathomimetika, inklusive Pseudoephedrin, Phenylephrin, Phenylpropanolamin, und Ephedrin
    7. Einnahme von Analgetika mit serotoninergen Eigenschaften, wie z.B. Meperidin, Tramadol, Methadon und Propoxyphen
    8. Einnahme von Serotonin Wiederaufnahmehemmern (SSRIs), inklusive Fluoxetin oder Fluvoxamin
    9. Einnahme von Dextromethorphan, Johanniskraut (St. John’s wort), Cyclobenzaprin oder anderen MAO Inhibitoren (selektiv oder nicht-selektiv)
    10. Einnahme von Antidepressiva
    11. Bestätigte Leberinsuffizienz oder abnormale Leberfunktion (ASAT und/oder ALAT mehr als 3-fach über dem oberen Normwert)
    12. Niereninsuffizienz (Serum-Kreatinin > 2.26 mg/dL)
    13. Schwere psychiatrische Erkrankung oder klinisch nachgewiesene Demenz, die die Bewertung von Symptomen erschwert
    14. Bekannte Überempfindlichkeit gegen einen Bestandteil der Prüfsubstanz
    15. Patient nicht in der Lage oder nicht willens den Anforderungen der Studie zu genügen (nach Einschätzung des Prüfers), oder im Notfall nicht zu erreichen
    16. Frauen im gebärfähigen Alter, wenn keine angemessene Verhütungsmethode angewendet wird
    17. Schwangere oder stillende Frauen
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint: survival time (time to death).
    Überlebenszeit (Zeit bis zum Tod).
    E.5.1.1Timepoint(s) of evaluation of this end point
    at each visit
    an jedem Visit
    E.5.2Secondary end point(s)
    1. Change of total score of ALS Functional Rating Scale - Revised (ALSFRS-R)
    2. Change in individual Quality of Life (SEIQoL, Schedule for the Evaluation of Individual Quality of Life)
    3. Change of the slow vital capacity (sVC)
    1. Veränderungen im Gesamtscore des ALS Functional Rating Scale - Revised (ALSFRS-R)
    2. Veränderungen der individuellen Lebensqualität (Quality of Life, SEIQoL, Schedule for the Evaluation of Individual Quality of Life)
    3. Veränderungen der Vitalkapazität (slow vital capacity, sVC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    at each visit
    bei jedem Visit
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To slow down the progress of the disease ALS
    Verlangsamung des Fortschreitens der Krankheit ALS
    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.8.2.4Number 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 concerned15
    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
    At the end of the study patients will be informed about further treatment and further care options by the investigator.
    Am Ende der Studie informiert der Prüfarzt alle Patienten über weitere Behandlungs- und Pflegemethoden .
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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.1.1.1In 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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state250
    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)
    At the end of the study patients will be informed about further treatment and further care options by the investigator.
    Am Ende der Studie erfolgte eine Beratung der Patienten über die weitere Behandlung sowie weitere Pflegemassnahmen durch den Investigator.
    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 Decision2013-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-28
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