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    Summary
    EudraCT Number:2017-002780-17
    Sponsor's Protocol Code Number:ND0612-315
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-27
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-002780-17
    A.3Full title of the trial
    A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    -
    A.4.1Sponsor's protocol code numberND0612-315
    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 SponsorNeuroDerm 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 supportNeuroDerm Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeuroDerm Ltd.
    B.5.2Functional name of contact pointOsnat Ehrman
    B.5.3 Address:
    B.5.3.1Street AddressRuhrberg Science building - Bell entrance - 5th floor - 3 Pekeris St.
    B.5.3.2Town/ cityRehovot
    B.5.3.3Post code7670212
    B.5.3.4CountryIsrael
    B.5.4Telephone number+1 703 864 8805
    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 nameND0612
    D.3.2Product code ND0612
    D.3.4Pharmaceutical form Solution for infusion in administration system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcarbidopa
    D.3.9.1CAS number 38821-49-7
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameCARBIDOPA
    D.3.9.4EV Substance CodeSUB06126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlevodopa
    D.3.9.1CAS number 59-92-7
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameLEVODOPA
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Yes
    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 SINEMET Plus
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    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 nameSINEMET
    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 INNlevodopa
    D.3.9.1CAS number 59-92-7
    D.3.9.3Other descriptive nameLEVODOPA
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcarbidopa
    D.3.9.1CAS number 38821-49-7
    D.3.9.3Other descriptive nameCARBIDOPA
    D.3.9.4EV Substance CodeSUB06126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Duodopa LD/CD 20/5 mg/mL
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Limited
    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 nameDuodopa LD/CD 20/5 mg/mL
    D.3.4Pharmaceutical form Intestinal gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntestinal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlevodopa
    D.3.9.1CAS number 59-92-7
    D.3.9.3Other descriptive nameLEVODOPA
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcarbidopa
    D.3.9.1CAS number 38821-49-7
    D.3.9.3Other descriptive nameCARBIDOPA
    D.3.9.4EV Substance CodeSUB06126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinson’s Disease
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease (PD) is a long-term degenerative disorder of the central nervous system that mainly affects the motor system.
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10034005
    E.1.2Term Parkinson's disease and parkinsonism
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess relative bioavailability of levodopa (LD) administered as ND0612,
    infused subcutaneously (s.c.), with orally co-administered LD/CD (Test)
    versus LD administered as carbidopa-levodopa enteral suspension (CLES),
    infused via a permanent percutaneous endoscopic gastrostomy with jejunal
    tube (PEG-J) or a naso-jejunal tube (Reference).
    E.2.2Secondary objectives of the trial
    • To assess the safety and tolerability of study treatments.
    • To assess the pharmacokinetics (PK) of LD and carbidopa (CD) derived from ND0612 plus oral LD/CD or from CLES.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or non-pregnant, non-lactating female patient with idiopathic PD currently responding to LD therapy, aged ≥30 years.
    2. Female patients must have a negative pregnancy test at screening and at admission.
    3. Patients must have a body mass index (BMI) within the range of 18.5 – 35 kg/m2, where BMI = body weight (kg) / height (m2) at screening.
    4. Must be willing and able to communicate and participate in the whole study.
    5. Must provide written informed consent.
    6. Area of administration to be evaluable for local skin reaction (normal skin without skin burns, scars or large tattoos in the area of administration).
    7. Must agree to use an adequate method of contraception (per local independent ethics committee requirements).
    For Cohort 1 only:
    8. Currently treated with CLES via PEG-J at a dose of at least 800 mg LD/day and up to 2200 mg LD/day.
    For Cohort 2 only:
    8. Stable PD treatment for at least 30 days before screening with at least 4 doses/day of LD/DOPA-decarboxylase-inhibitor (or at least 3 doses/day of Rytary or Numient) or for whom the conversion to oral LD/CD IR tablets will lead to a LD dose between 800 and 2200 mg/day and according to Investigator judgment motor fluctuations cannot be further improved by adjusting oral LD medication.
    9. Must have a minimum of 2 hours of “OFF” time per day as estimated by the patient.
    E.4Principal exclusion criteria
    1. Previously unable to tolerate ND0612 and/or have experienced intolerable adverse drug reactions associated with its use or serious adverse reaction.
    2. Atypical or secondary parkinsonism.
    3. Acute psychosis or hallucinations within the past 6 months prior to screening.
    4. Any relevant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the Investigator, makes the patient unsuitable for study entry or potentially unable to complete all aspects of the study.
    5. Any malignancy in the 5 years prior to randomization (excluding basal cell carcinoma of the skin, transitional cell carcinoma in situ or cervical carcinoma in situ that have been successfully treated).
    6. Positive serum serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) at the screening visit.
    7. Patients with a history of drug abuse or alcoholism within the past 12 months prior to screening or positive drugs of abuse or alcohol test result at the screening visit and/or on admission.
    8. Routine alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125-mL glass of wine).
    9. Clinically significant electrocardiogram (ECG) rhythm abnormalities.
    10.Renal or liver dysfunction that may alter drug metabolism including: serum creatinine >1.5 mg/dL, serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x upper limit of normal (ULN), total serum bilirubin >2.5 mg/dL.
    11. Patients who have previously been enrolled in this study.
    12. Patients who do not have suitable veins for multiple venipunctures / cannulation as assessed by the Investigator at the screening visit.
    13. Psychiatric, neurological or behavioral disorders that may interfere with the conduct or interpretation of the study, including dementia, or patients who are considered to be violent or at suicidal risk by the Investigator.
    14. Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator or serious hypersensitivity to any drug or the formulation excipients. Hay fever is allowed unless it is active.
    15.Blood loss of greater than 500 mL within the previous 3 months prior to first dosing.
    16. Current use of the dopamine agonist pramipexole within 1 month before Day 1.
    17. Intake of domperidone within 2 days before Day 1 or planned to be taken before last PK sampling.
    18. Intake of
    - Catechol-O-methyltransferase (COMT) inhibitors as entacapone, opicapone or agents including them (i.e. Stalevo)
    - DDCI other than CD (i.e. beserazide, methyldopa [Aldomet, Aldoril, Dopamet, Dopegyt], DL-x-Difluoromethyl DOPA (DFMD), 3',4',5,7- Tetrahydroxy-8-methoxyisoflavone)
    - Rytary or Numient within 2 days prior randomization. Patients who are taking any of these medications at screening should be converted to an equivalent dose of oral LD/CD IR tablets as detailed in Table 4).
    19. Intake of donepezil (Aricept) within 14 days before Day 1.
    20. Intake of trihexylphenidyl (benzhexole) within 2 days before Day 1.
    21. Intake of multivitamins with iron (e.g. Pimavanserin) within 8 hours prior to start of study treatment on Day 1
    22. Intake of calcium carbonate, sodium carbonate, aluminum hydroxide, aluminum carbonate, magnesium hydroxide or magnesium oxide within 8 hours prior to start of study treatment on Day 1
    23.Current participation in a clinical study with an investigational compound or past participation within the last 30 days or within less than 5 times the half-life of the investigational product administered in the clinical research study, whichever is longer.
    24.Any PD-related feature or symptom that could interfere with the study conduct and results as assessed by the Investigator.
    25.History or presence of narrow-angle glaucoma.
    26.Any history or presence of prolactin-releasing pituitary tumor (prolactinoma).
    27. Patients who are not willing to adhere to the protocol-prescribed study
    restrictions.
    28. Patients who are employees of a study site or Sponsor, or immediate family members thereof.
    29. The patient is a vulnerable patient, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
    Cohort 2 only:
    30.Contraindications for insertion of a naso-jenunal tube, e.g. recent nasal surgery, nasal fractures, upper gastrointestinal obstruction, esophageal atresia/stenosis, history of significant upper gastrointestinal bleeding,
    esophageal varices or coagulation abnormalities..
    E.5 End points
    E.5.1Primary end point(s)
    For LD:
    • Cmax and AUC24 the concentrations measured with the following 24-hours periods will be included into the calculation of AUC24:
    for ND0612 16-hours regimen (Test 1): from start of dosing until 24 hours post start of dosing (06:00 to 06:00);
    for ND0612 24-hours regimen (Test 2): from start of second low rate period until end of third high rate period (20:00 to 20:00);
    for CLES regimen: from start of dosing until 24 hours post start of dosing (06:00 to 06:00)
    E.5.1.1Timepoint(s) of evaluation of this end point
    For LD:
    • Cmax and AUC24 the concentrations measured with the following 24-hours periods will be included into the calculation of AUC24:
    for ND0612 16-hours regimen (Test 1): from start of dosing until 24 hours post start of dosing (06:00 to 06:00);
    for ND0612 24-hours regimen (Test 2): from start of second low rate period until end of third high rate period (20:00 to 20:00);
    for CLES regimen: from start of dosing until 24 hours post start of dosing (06:00 to 06:00)
    E.5.2Secondary end point(s)
    For LD:
    • AUC16 (i.e. 6:00-22:00 for CLES and ND0612 16-hours and 6:00-22:00 last day of administration for ND0612 24-hours)
    • Cavg, (AUCt/t represents the mean concentration within the dosing period)
    • End points assessing the variability of the concentrations: these endpoints will be assessed both during the expected stable phase as defined in the SAP. For the piecewise approach, the end points are calculated separately for the 2 or 3 hour periods, as defined in the SAP.
    o Fluctuation Index (FI; ([Cmax-Cmin])/[Cavg])
    o Peak to Trough (PtT = Cmax/Cmin)
    o Swing ([Cmax-Cmin]/[Cmin])
    • t1/2 (if data permit)
    • lambda z (if data permit)
    • tmax
    • Ctrough (last planned PK sample in a period)
    For CD:
    • Cmax
    • AUC24
    • Ctrough (last planned PK sample in a period)
    For 3-OMD:
    • Cmax
    • AUC24
    • Ctrough (last planned PK sample in a period)
    E.5.2.1Timepoint(s) of evaluation of this end point
    For LD:
    • AUC16 (i.e. 6:00-22:00 for CLES and ND0612 16-hours and 6:00-22:00 last day of administration for ND0612 24-hours)
    • Cavg, (AUCt/t within the dosing period)
    • End points assessing the variability of the concentrations: these endpoints will be assessed both during the expected stable phase as defined in the SAP. For the piecewise approach, the end points are calculated separately for the 2 or 3 hour periods, as defined in the SAP.
    • Ctrough (last planned PK sample in a period)
    For CD:
    • Cmax
    • AUC24
    • Ctrough (last planned PK sample in a period)
    For 3-OMD:
    • Cmax
    • AUC24
    • Ctrough (last planned PK sample in a period)
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Duopa, Duodopa
    E.8.2.4Number of treatment arms in the trial4
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    France
    Italy
    Netherlands
    Spain
    United States
    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, completion of the last patient’s 4-weeks’ return
    visit (follow-up visit)
    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 months4
    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 months11
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 50
    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)
    Patients who complete the treatment periods will be offered to be enrolled to a separate study provided they are assessed by the Investigator as suitable candidates for the study who are capable of following study procedures independently or with the assistance of a study partner. In the follow-on study, they will be treated with open-label ND0612 for up to 48 weeks.
    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 Decision2018-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-15
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