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    The EU Clinical Trials Register currently displays   43800   clinical trials with a EudraCT protocol, of which   7272   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:2009-013097-40
    Sponsor's Protocol Code Number:NP031112-08B02
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-013097-40
    A.3Full title of the trial
    A double-blind, placebo-controlled, randomized, parallel-group study evaluating the
    safety, tolerability and efficacy of two different oral doses of NP031112, a GSK-3
    inhibitor, versus placebo in the treatment of patients with mild to moderate
    Progressive Supranuclear Palsy.
    A.3.2Name or abbreviated title of the trial where available
    TAUROS
    A.4.1Sponsor's protocol code numberNP031112-08B02
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNoscira S.A.
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/679
    D.3 Description of the IMP
    D.3.1Product nameNP031112
    D.3.2Product code NP031112 600mg
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 865854-05-3
    D.3.9.2Current sponsor codeNP031112
    D.3.9.3Other descriptive name4-benzyl-2-naphtalen-1-yl-1,2,4-thiadiazolidine-3,5-dione
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/679
    D.3 Description of the IMP
    D.3.1Product nameNP031112
    D.3.2Product code NP031112 800mg
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 865854-05-3
    D.3.9.2Current sponsor codeNP031112
    D.3.9.3Other descriptive name4-benzyl-2-naphtalen-1-yl-1,2,4-thiadiazolidine-3,5-dione
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboPowder for oral suspension
    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 placeboPowder for oral suspension
    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
    Mild to Moderate Progressive Supranuclear Palsy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10036813
    E.1.2Term Progressive supranuclear palsy
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level PT
    E.1.2Classification code 10036813
    E.1.2Term Progressive supranuclear palsy
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the overall clinical change assessed by the Progressive Supranuclear Palsy Rating Scale of Golbe after 52 weeks of treatment with 2 different doses of NP031112 vs. placebo in patients with possible or probable mild-to-moderate Progressive Supranuclear Palsy (PSP).
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of 2 different doses of NP031112 administered over 52 weeks in patients with possible or probable mild to moderate PSP.
    To evaluate the clinical functional changes after 52 weeks of treatment with 2 different doses of NP031112 vs. placebo on:
    o motor function
    o cognition
    o behavior
    o activities of daily living (ADL)
    o quality of life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women with a diagnosis of possible or probable PSP according to the clinical criteria of the National Institute of Neurologic Diseases and Stroke – the Society for PSP (Appendix 1)

    2. Age of 40 to 85 years (patients over 85 years could be included after a previous assessment by the Investigator and approved by the sponsor).

    3. Brain MRI study within 24 months before the Baseline visit excluding other potential causes of parkinsonism, especially cerebrovascular lesions and space occupying lesions.

    4. Mild to moderate stage of disease severity according to a score of 1 to 4 in the Golbe Staging System (Appendix 2).

    5. Female patients must be without childbearing potential: either surgically sterilized or at least 1 year postmenopausal (confirmed by follicle-stimulating hormone [FSH] >20 international units [IUs]). Male patients must be willing to use barrier contraception (condom) during the study and for 6 months after the last treatment administration.

    6. A caregiver (or dedicated nurse) living in the same household or interacting with the patient for >4 hours every day able to assure the correct preparation and administration of the study drug.

    7. Patients living at home or in a retirement home not requiring continuous nursing care.

    8. General health status acceptable for a participation in a 64-week clinical trial.

    9. Ability to swallow 100 mL of water suspension.

    10. Any concomitant medication for PSP must be well-tolerated and unchanged for at least 4 weeks prior to the Baseline visit and its dose and regimen should be maintained during the study if there are no clinical reasons to modify it.

    11. Occupational, physical, respiratory, or speech therapy is allowed but it must be stable for at least 4 weeks prior to baseline.

    12. Pharmacological treatment of any other chronic condition must be stable and well-tolerated for at least 4 weeks prior to baseline. Analgesics, occasional per request nonsteroidal anti-inflammatory agents, and treatments for transient or emergent conditions are allowed.

    13. Signed informed consent (IC) by the patient (or his/her legal representative, this is applicable in Spain) prior to the initiation of any study-specific procedure.
    E.4Principal exclusion criteria
    1. Failure to perform screening or baseline examinations.

    2. Hospitalization or change of chronic concomitant medication 1 month prior to or during the screening period (apart from pre-planned hospitalization for a condition, which did not deteriorate since 1 month prior to the screening period).

    3. Clinical, laboratory or neuroimaging findings consistent with:
    • other primary degenerative diseases such as Parkinson’s disease; dementia with Lewy bodies; corticobasal degeneration; frontotemporal dementia; multiple system atrophy; parkinsonism-dementia complex of Guam, Kii or Guadalupe; Alzheimer’s disease; amyotrophic lateral sclerosis; Creutzfeld-Jakob Disease; Huntington’s disease; Down’s syndrome; etc.
    • cerebrovascular disease as major, strategic or multilacunar infarcts, or extensive white matter lesions scoring 3 in the Wahlund’s scale [Wahlund et al., 2001].
    • other central nervous system diseases (hydrocephalus, severe head trauma, tumours, subdural haematoma or other relevant space occupying processes, etc.).
    • epilepsy.
    • other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present clinically active hypothyroidism, clinically significant vitamin B12 or folate deficiency, clinically significant serum electrolyte disturbances, juvenile onset diabetes mellitus, etc.).

    4. A current Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnosis of active major depression, schizophrenia or bipolar disorder.

    5. Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, may bias the clinical or mental assessment or put the patient at special risk, such as:
    • chronic liver disease, as indicated by liver function test abnormalities (ALAT, ASAT, bilirubin or GGT out of range) positive serology for Hepatitis C, or other clinical manifestations of liver disease
    • respiratory insufficiency
    • renal insufficiency (serum creatinine >2 mg/dL (>150 μmol/L) and creatinine clearance <60 (according to Cockcroft-Gault formula)
    • heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within 6 months before screening).
    • bradycardia (heart beat <50/min) or tachycardia (heart beat >95/min)
    • episodes of unstable or uncontrolled hypertension (systolic pressure >160 mm Hg or diastolic pressure >100 mm Hg) or hypotension (systolic pressure <90 mm Hg or diastolic pressure <45 mm Hg) during the 2 months prior to the Baseline visit.
    • atrioventricular block (type II / Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcF interval (males >450 msec and females >470 msec using Fridericia’s formula: QTc = QT/cube root of RR).
    • uncontrolled diabetes mellitus.
    • malignant tumors within the last 5 years except skin malignancies (other than melanoma) or indolent prostate cancer.
    • metastases.

    6. Disability that may prevent the patient from completing all study requirements (e.g. blindness, deafness, and severe language difficulty).

    7. Chronic daily drug intake of:
    • drugs metabolized by the cytochrome P450 (CYP)3A4 with narrow therapeutic window
    (acenocoumarol, warfarin, and digitoxin)
    • anticonvulsants indicated for epileptic seizures
    • systemic anticholinergics with relevant action on central nervous system
    • acetylcholinesterase inhibitors
    • neuroleptics except quetiapine, clozapine or other atypical neuroleptics
    • nootropics such as piracetam, propentofylline, hydergine, vinpocetine, ginkgo biloba, coenzyme Q-10, idebenone and derivatives
    • centrally active anti-hypertensive drugs such as clonidine, α-methyl dopa, guanidine, and guanfacine
    • systemic cortico-steroids or immunosuppressants
    • systemic nonsteroidal anti-inflammatory agents (except taken as occasional medication per request or acetylsalicylic acid up to 100 mg/day as an antiplatelet agent).
    • memantine, lithium, valproic acid or other GSK-3 inhibitors within 3 months prior to the Baseline visit.

    8. Suspected or known history of drug abuse or excessive alcohol intake*

    9. Suspected or known allergy to any components of the study treatments.

    10. Enrollment in another investigational drug study within 3 months before the Baseline visit.

    11. Any condition, which in the opinion of the Investigator, makes the patient unsuitable for inclusion or likely to be non-compliant.

    * More than 21 units per week for men and more than 14 units a week for women; or consumption of more than 8 units in a single episode. 1 unit equals approximately 1 glass of wine, 250 ml of beer or 1 shot (25 ml) of a spirit
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoint: The change from Baseline between the 2 active study medication groups compared with the placebo group in the Progressive Supranuclear Palsy Rating Scale of Golbe.


    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 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
    Bioanalysis
    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.8.3 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Last Patient Last 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 months20
    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 months20
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 140
    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)
    Standard care will resume
    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 Decision2009-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-10
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