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    Summary
    EudraCT Number:2009-017174-20
    Sponsor's Protocol Code Number:EMR701165_023
    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:2010-01-07
    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 number2009-017174-20
    A.3Full title of the trial
    A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to determine if safinamide can attenuate levodopa induced dyskinesia in Parkinson’s disease.
    A.3.2Name or abbreviated title of the trial where available
    LID study
    A.4.1Sponsor's protocol code numberEMR701165_023
    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 SponsorMerck Serono S.A. - Geneva
    B.1.3.4CountrySwitzerland
    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 supportMerck Serono S.A. - Geneva
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Center Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Str. 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone numberNot Applicable
    B.5.5Fax numberNot Applicable
    B.5.6E-mailservice@merck.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 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 nameSafinamide
    D.3.2Product code NW-1015E, EMD 1195686, MSC2191632B
    D.3.4Pharmaceutical form Film-coated 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 INNsafinamide
    D.3.9.1CAS number 202825-46-5
    D.3.9.2Current sponsor codeNW-1015E, EMD 1195686, MSC2191632B
    D.3.9.3Other descriptive name(S)-(+)-2-(4-(3-fluorobenzyl)oxybenzyl)aminopropanamide methanesulfonate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboFilm-coated tablet
    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
    Idiopathic Parkinson's disease
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease
    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 14.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to determine the maximum reduction in Unified Dyskinesia Rating Score (UDysRS) compared to baseline across all post-baseline dose visits.
    E.2.2Secondary objectives of the trial
    To explore the impact of safinamide dose for anti-dyskinetic activity of safinamide in late-stage Parkinson's Disease (PD) patients with l-dopa induced dyskinesias, and to evaluate changes from baseline in motor fluctuations, motor function, activities of daily living, and change in global clinical status.
    To further characterize the safety and tolerability of safinamide in late-stage Parkinson’s disease patients with l-dopa induced dyskinesias.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The desired population to trial is advanced idiopathic PD patients treated with L-dopa and suffering from temporally predictable L-dopa induced peak-dose dyskinesia.
    For inclusion in the trial, all of the following inclusion criteria must be fulfilled:
    1. The subject has given his/her written informed consent to participate in the trial.
    2. The subject presents with a diagnosis of idiopathic Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
    3. The subject is an out-patient aged 30 years or above.
    4. PD subjects with a Hoehn and Yahr disease staging of II-IV (in the ON state).
    5. PD subjects experiencing levodopa induced dyskinesias, specifically predictable peak-dose dyskinesia.
    6. Peak-dose dyskinesia must be considered by the subject to be problematic and/or disabling.
    7. Peak-dose dyskinesia must warrant medical treatment in the Investigator’s opinion.
    8. The subject has participated successfully in a diary-card training session.
    9. In the judgment of the Investigator based on the subject’s history, previous treatments, and the clinical presentation, the subject is considered as being optimally treated at the present time (i.e., further adjustments of current medication are not expected to further improve the subject's symptoms of Parkinson's disease).
    10. Stable dose of all PD drugs for at least 4 weeks before Screening Visit. This may include: levodopa dopamine agonists, COMT inhibitors, and anticholinergics.
    11. The dose of levodopa and all PD drugs used during the trial must remain unchanged throughout the trial.
    12. Female subjects must be neither pregnant or breast-feeding and must lack child-bearing potential, as defined either by:
    - be either post menopausal for at least 2 years, surgically sterilised, or have undergone hysterectomy, or
    - if of child bearing potential, be willing to avoid pregnancy by using an adequate method of contraception for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, women of childbearing potential are defined as all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive.
    13. The subject shows adequate compliance with the schedule for intake of trial medication and the completion of the diaries.
    E.4Principal exclusion criteria
    Subjects are not eligible for this trial if they fulfil any of the following exclusion criteria:
    1. The subject has participated in any safinamide clinical trial before.
    2. The subject is experiencing exclusively diphasic, off state, myoclonic, dystonic, or akathetic dyskinesias without peak dose dyskinesia.
    3. (For female subjects) The subject is pregnant or lactating.
    4. Treatment with a MAO-B inhibitor within the eight weeks prior to the screening visit.
    5. Treatment with amantadine in the four weeks prior to the screening visit or budipine in the eight weeks prior to the screening visit.
    6. Treatment with opioids (e.g., tramadol, meperidine derivatives), SNRIs (e.g. venlafaxine, duloxetine), tri- or tetra-cyclic antidepressants, in the 8 weeks prior to the screening visit. Dextromethorphan will be permitted if used for treating cough.
    7. The subject has received neurosurgical intervention related to PD (e.g. deep brain stimulation, thalamotomy etc.) or is scheduled to do so during the trial period.
    8. Current clinically significant gastro-intestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, including acute gastric ulcer, hypertension that is not well controlled, asthma, chronic obstructive pulmonary disease (COPD), and unstable Type I diabetes. Subjects with a history of gastric ulcer who have not had a recent episode of acute gastritis and are not currently experiencing gastric pain will be eligible for inclusion.
    9. Neoplastic disorder, which is either currently active or has been in remission for less than one year.
    10. Diagnosis of HIV, or positive test for Hepatitis C antibodies, or Hepatitis B surface antigen.
    11. Concomitant disease likely to interfere with trial medication (e.g. capable of altering absorption, metabolism, or elimination of the trial drug).
    12. The subject has any clinically significant illness that, in the Investigator’s opinion, might interfere with the subject's ability to participate in the trial.
    13. Second- or third-degree atrio-ventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months of the screening visit, or a significant ECG abnormality, including QTc – 450 msec (males) or – 470 msec (females), where QTc is based on Bazett’s correction method.
    14. Ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or diabetic retinopathy
    15. The subject is suffering from dementia or other severe neuropsychiatric illness that prevents him/her from giving informed consent, or has a total score on the MoCA <23 points.
    16. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
    17. Known hypersensitivity to the trial treatment(s), including placebo or other comparator drug(s).
    18. The subject has legal incapacity or limited legal capacity.
    19. The subject is participating in another clinical trial or has done so within the past 30 days.
    20. Treatment with a drug that has hepatotoxic potential e.g., tamoxifen, within 4 weeks, or received radiation therapy or a drug with cytotoxic potential, e.g, chemotherapy, within 1 year prior to the screening visit.
    21. Subjects with current diagnosis of substance abuse (DSM-IV) or history of alcohol or drug abuse in the past 3 months.
    E.5 End points
    E.5.1Primary end point(s)
    Unified Dyskinesia Rating Scale (UDysRS) - maximum reduction in UDysRS total score from baseline to all post-baseline dose visits.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 13
    E.5.2Secondary end point(s)
    Efficacy variables:
    - Complete new MDS-UPDRS and subscales
    - Patients diary
    - Parkinson Disease Dyskinesia Scale – 26 items (PDYS-26)
    - Clinician Global Impression (CGI) (dyskinesia specific)
    - Patient Global Impression (PGI) (dyskinesia specific)

    Safety variables including physical, neurological, ophthalmological, and dermatological examinations, medical history, adverse event assessments, hematologic, urine, and clinical chemistry results, and ECGs from baseline to end of trial.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 13
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Austria
    Canada
    France
    Germany
    South Africa
    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
    The end of trial will coincide with the date at which the last data point from the Last Patient Last Visit (LPLV), which was required for statistical analysis (i.e. key safety and efficacy results for decision making), was received. This should correspond with database lock.
    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 months24
    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 months24
    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.1.3Elderly (>=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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 24
    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)
    After a subject has completed the trial or has withdrawn early, usual treatment will be administered, if required, in accordance with the trial site’s standard of care and generally accepted medical practice and depending on the subject’s individual medical needs. Subjects will also be offered the possibility to enroll in an existing open-label trial.
    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 Decision2010-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-12
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