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    Summary
    EudraCT Number:2020-006067-28
    Sponsor's Protocol Code Number:CST103/CST107-CLIN-011
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-11-18
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-006067-28
    A.3Full title of the trial
    A Phase II, Randomized, Placebo-Controlled, Double-Blind, Crossover, Study of the Pharmacodynamic Effects of CST-103 co-administered with CST-107 on the Central Nervous System in Subjects with Neurodegenerative Disorders
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate if CST-103 and CST-107 has an effect on the brain in patients with progressive disease of the nervous system.
    A.3.2Name or abbreviated title of the trial where available
    PD Effects of CST-103/CST-107 on CNS in Neurodegenerative Disorders
    A.4.1Sponsor's protocol code numberCST103/CST107-CLIN-011
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04739423
    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 SponsorCuraSen Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportCuraSen Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCuraSen Therapeutics, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address930 Brittan Avenue, #306
    B.5.3.2Town/ citySan Carlos
    B.5.3.3Post codeCA 94070
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 650 475 2842
    B.5.6E-mailclinicaltrials@curasen.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 Yes
    D.2.1.1.1Trade name Spiropent
    D.2.1.1.2Name of the Marketing Authorisation holderHikma 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.3.1Product nameSpiropent
    D.3.2Product code CST-103
    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 INNClenbuterol Hydrochloride
    D.3.9.1CAS number 21898-19-1
    D.3.9.2Current sponsor codeCST-103
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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 nameNadolol
    D.3.2Product code CST-107
    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 INNNadolol
    D.3.9.1CAS number 42200-33-9
    D.3.9.2Current sponsor codeCST-107
    D.3.9.4EV Substance CodeAS2
    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 placeboCapsule
    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
    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
    Patients with Parkinson’s Disease with REM sleep behaviour disorder, Mild Cognitive Impairment, Dementia with Lewy Bodies and Parkinson’s Disease Dementia.
    E.1.1.1Medical condition in easily understood language
    Patients with Parkinson's disease and patients with memory problems.
    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 24.0
    E.1.2Level LLT
    E.1.2Classification code 10012284
    E.1.2Term Dementia due to Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10009846
    E.1.2Term Cognitive impairment
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067889
    E.1.2Term Dementia with Lewy bodies
    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 is to identify a CNS signal in one of the planned pharmacodynamic measures (emotional facial processing, cognitive fluctuations) after multiple doses of CST-103 co-administered with CST-107 in subjects with neruodegenerative diseases.

    The objective is to identify an improvement in cognition, for example in learning, thinking and remembering, a CNS signal in one of the planned pharmacodynamic measurements after multiple oral doses of CST-103 in the presence of CST-107 in four populations of subjects with neurodegenerative disorders. This includes patients with Parkinson's Disease (PD) and REM Sleep Behaviour Disorder (RBD+PD), Mild Cognitive Impairment (MCI), Parkinson’s Disease Dementia (PDD) and Dementia with Lewy Bodies (DLB).

    The primary objective for Cohort A population is a change in emotional facial recognition, a measure of mood. The primary objective for the Cohort B population is to assess the change in cognitive fluctuations.
    E.2.2Secondary objectives of the trial
    The secondary objectives for all subjects include the comparison of the effect of CST-103 co-administered with CST-107 with that of placebo on the following:
    Cognition, sleep, pupillary reactivity, mood assessment, safety and tolerability of CST-103 co-administered with CST-107,the pharmacokinetic (PK) profiles of CST-103 and CST-107.

    The exploratory objectives are to characterise the effects of CST-103 co-administered with CST-107 on inflammatory and neurodegenerative biomarkers. In addition the effects of these drugs will be examined on performance in a sustained attention task and on freezing of gait in the subjects with Parkinson's disease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cohort A:Subjects with RBD+PD:
    1.Male or female subjects ≥ 40 and ≤ 80 years of age, at time of informed consent.
    2.Subject diagnosed with Parkinson’s Disease, as defined by the United Kingdom Parkinson Disease Brain Bank criteria, associated with REM sleep behaviour disorder (RBD+PD), diagnosed according to the International Classification of Sleep Disorders, Third Edition (ICSD-3) (albeit documentation by polysomnography is not required) and positive response to the REM Sleep Behaviour Disorder Single-Question Screen (RBD1Q).
    3.Subject who is Modified Hoehn & Yahr ≥ stage 1 and ≤ stage 3 during “On” period as documented in the 3 months prior to Screening or completed at Screening.
    4.Montreal Cognitive Assessment (MoCA) score ≥ 18 and ≤ 28.
    5. Intentionally left blank
    Subjects with MCI:
    6.Male or female subjects ≥ 50 and ≤ 80 years of age, at time of informed consent.
    7.Subjects who meet the criteria for amnestic Mild Cognitive Impairment (MCI) as per the National Institute on Aging-Alzheimer's Association core clinical criteria.
    8.Montreal Cognitive Assessment (MoCA) score ≥ 18 and ≤ 26.
    9.No dementia according to the International Classifications of Diseases (ICD)-10 and Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV.
    10.A memory complaint reported by the subject or his/her partner, family member or caregiver
    11.A score of greater than or equal to one standard deviation below age and educational norms in the Digit Symbol Substitution Test (DSST) during Screening.
    12.Cognitive decline not primarily caused by vascular, traumatic, or medical problems (alternative causes of cognitive decline are ruled out).
    13.Intentionally left blank

    Cohort B: Subjects with Dementia with Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD):
    14.Male or female subjects ≥ 50 and ≤ 80 years of age, at time of informed consent.
    15.A diagnosis of dementia associated with Dementia with Lewy Bodies.
    16.Documented cognitive fluctuations endorsed on the Dementia Cognitive Fluctuation Scale (DCFS) with a combined score of >8 in items 4, 11, 12 and 14.
    17.Montreal Cognitive Assessment (MoCA) score ≥ 18 and ≤ 26.
    18.Subject having informant or caregiver throughout the study who will submit written consent to cooperate with this study, who routinely stays with subject 12 hours or more a week, assists with treatment compliance, provides assessments and is able to escort the subject on required visits to study institution.
    19.Subject who is Modified Hoehn & Yahr ≥ stage 1 and ≤ stage 3 during “On” period as documented in the 3 months prior to Screening or completed at Screening.
    20.Stable concomitant medical and/or psychiatric illnesses in the judgement of the PI.

    For ALL Subjects:
    21.Unless confirmed to be azoospermic (vasectomized or secondary to medical cause), males must agree to use a male condom from Day 1 throughout the study when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant.
    Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a condom during each episode of penile-vaginal penetration until after the Follow-Up Visit.
    22.Females of childbearing potential (i.e., not postmenopausal or surgically sterile) who have a male partner must have a negative serum pregnancy test result and must agree to one of the following from start of Screening through 30 days after the last study medication administration:
    a.use a reliable method of birth control (refer to protocol section 5.6), or
    b.monogamous relationship with a male partner of confirmed sterility, or
    c.practice complete abstinence (refer to protocol section 5.6).
    23.Females of non-childbearing potential may be enrolled if it is documented that they are postmenopausal (refer to protocol section 5.6).
    24.Body weight greater or equal to 50 kg and body mass index (BMI) between 18 and 35 kg/m2, inclusive at Screening.
    25.Stable medical conditions for 3 months prior to Screening visit (e.g., controlled hypertension, dyslipidemia).
    26.Willing to follow the protocol requirements and comply with protocol restrictions.
    27.Capable of providing informed consent and complying with study procedures (completion of self-assessment rating scales and use of wearable devices). Subjects who are unable to provide consent may use a Legally Authorized Representative
    E.4Principal exclusion criteria
    1.Subjects with poorly controlled hypertension despite lifestyle modifications and/or pharmacotherapy.
    2.Subjects with pulmonary disease, including asthma if requiring use of a β2-adrenergic bronchodilator, or evidence of clinically significant moderate or severe pulmonary symptoms.
    3.Clinical signs indicating syndromes such as corticobasal degeneration, supranuclear gaze palsy, multiple system atrophy, chronic traumatic encephalopathy, signs of frontotemporal dementia, history of stroke, head injury or encephalitis, cerebellar signs, early severe autonomic involvement, or Babinski sign.
    4.Current evidence or history in past two years of epilepsy, focal brain lesion, head injury with loss of consciousness or meeting DSM-IV diagnostic criteria for psychotic disorders, such as Schizophrenia or Bipolar Disorder, or have unstable concomitant psychiatric symptomatology that is not believed by the Investigator to be associated with PDD or DLB.
    5.Evidence of any significant clinical disorder or laboratory finding (or in the case of potassium levels below the normal range)that renders the participant unsuitable for receiving an investigational drug including clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine (excluding managed hypo and hyperthyroidism), metabolic, renal or other systemic disease or laboratory abnormality.
    6.Participants with a history of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
    7.Any clinically significant illness or disease (apart from those typically associated with NDD) as determined by medical and surgical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory assessments conducted at Screening.
    8.Clinically significant abnormalities of ECG, including QTcF > 450 ms, for males and QTcF > 470 ms for females, and/or HR < 50 beats per minute, or evidence of clinically significant bundle branch blocks, as indicated by 12-lead ECG in a supine position at Screening or during the Lead-In Period.
    9.A calculated creatinine clearance of ≤70 mL/min according to the Cockcroft-Gault equation.
    10.Current use of any prohibited prescription medication, over-the-counter medication, or herbal supplements/products (listed in protocol section 5.4), during Screening or throughout study, unless approved by both the Investigator and the Sponsor Medical Monitor.
    11. Known hypersensitivity to Spiropent (clenbuterol), Corgard (nadolol) or intolerance to lactose. Subjects with hereditary galactose intolerance (e.g., galactosemia, lactase deficiency or glucose galactose malabsorption) should be excluded.
    12.Prior treatment with any investigational drug ≤90 days prior to dosing (Day 1), or ≤5 half-lives of the drug (whichever is longer), or current enrollment in any other study treatment or disease study except for observational studies.
    13.Prior treatment with any β-AR agonists or β-AR blockers (includes oral meds, IV or inhaled) or any meds that impact adrenergic signalling within the last month prior to Screening.
    14.Known or suspected alcohol or substance abuse within the past 12 months and/or positive test for alcohol or drugs of abuse at Screening or Day 1.
    15.Suicidal ideation with actual intent or plan (“Yes” answer on the C-SSRS ideation items 4 or 5) within 3 months prior to study Screening.
    16.Positive screening test for hepatitis C antibody (HCV Ab) or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] at Screening). Subjects with immunity to hepatitis B (defined as negative HBsAg and positive hepatitis B surface antibody [HBsAb]) are eligible to participate in the study.
    17.Positive screening test for human immunodeficiency virus (HIV).
    18.Current infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
    19.Known hypersensitivities to adhesives or hydrogel.
    20. Females who are breastfeeding.
    21.Any other reason for which the PI considers it is not in the best interest of the participant to undertake the study.
    22. Inability to undergo a clinical MRI of the brain due to claustrophobia, inability to lie supine for a prolonged time period, or other contraindications to undergoing an MRI of the brain including, but not limited to, pacemakers; implantable cardioverter defibrillators; cochlear implants; cerebral aneurysm clips; implanted infusion pumps; implanted nerve stimulators; metallic splinters in the eye; and, other magnetic, electronic or mechanical implants or clinical findings that in the judgment of the investigator would pose a potential hazard in combination with MRI. (NOTE: this is a procedural exclusion, not a study exclusion.)

    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints include:

    Cohort A
    Comparison of the effects of CST-103 co-administered with CST-107 vs placebo on change in Negative Emotional Bias in the Facial Expression Recognition Task.

    Cohort B
    Comparison of the effects of CST-103 co-administered with CST-107 vs placebo on Cognitive Fluctuations as measured by:
    1. Spectral analysis of waking EEG
    2. Pupillometry
    3. Dementia Cognitive Fluctuation Scale (DCFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to protocol.
    E.5.2Secondary end point(s)
    The secondary endpoints will compare the effect of CST-103 co-administered CST-107 with that of placebo on the following:
    1. Verbal fluency test (alphabet & category) and CANTAB cognitive assessments, which include the following:
    • Reaction Time (RTI)
    • Rapid Visual Information Processing (RVP)
    • Verbal Recognition Memory (VRM) Phase I
    • Adaptive Tracking Task (ATT)
    • Paired Associates Learning Task (PAL)
    • Stop Signal Task (SST)
    • Delayed Verbal Recall
    2. Assessment of sleep using the Epworth Sleepiness Scale (ESS)
    3. Change in pupillary diameter as measured using the pupillary light reflex test
    4. Geriatric Depression Scale (GDS)
    5. Adverse events (AE), electrocardiograms (ECGs), vital signs, laboratory safety tests (hematology, chemistry and urinalysis).
    6. Plasma PK parameters of CST-103 and CST-107 (including Cmax, tmax, AUCt, AUCinf, t1/2)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to protocol.
    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 Yes
    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 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 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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    New Zealand
    United Kingdom
    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 years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days30
    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: 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Incl. crit #27 allows an LAR to consent on subject's behalf.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 40
    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)
    The study medications will not be available for use after completion of the study.
    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 Decision2021-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-18
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