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    Summary
    EudraCT Number:2014-000348-14
    Sponsor's Protocol Code Number:NSTATIN
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-02-27
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2014-000348-14
    A.3Full title of the trial
    Statin-treatment and peripheral neuropathy - a randomized clinical trial
    Statin-behandling og perifer neuropati - et randomiseret klinisk forsøg
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cholesterol-lowering treatment and neuropathy
    Kolesterolsænkende medicin og nervebetændelse
    A.4.1Sponsor's protocol code numberNSTATIN
    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 SponsorOdense University Hospital, Department of Neurology
    B.1.3.4CountryDenmark
    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 supportRegion Syddanmark
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportOdense University Hospital - The Free Fonding
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportOdense University Hospital, Department og Neurology
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOdense University Hospital, Department of Neurology
    B.5.2Functional name of contact pointSøren Hein Sindrup
    B.5.3 Address:
    B.5.3.1Street AddressSøndre Boulevard 29
    B.5.3.2Town/ cityOdense
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4565412471
    B.5.5Fax number+4565413389
    B.5.6E-mailsoeren.sindrup@rsyd.dk
    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 Simvastatin
    D.2.1.1.2Name of the Marketing Authorisation holderBluefish
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.11 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 Yes
    D.2.1.1.1Trade name Simvastatin
    D.2.1.1.2Name of the Marketing Authorisation holderBluefish
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.11 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 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 Simvastatin
    D.2.1.1.2Name of the Marketing Authorisation holderOrion
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.11 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
    Patients with cerebral infarction or transient ischemic attack.
    Patienter med cerebralt infarkt, eller transitorisk iskæmisk attak.
    E.1.1.1Medical condition in easily understood language
    Patients with ischemic stroke or transient ischemic stroke.
    Patients med blodprop i hjernen eller forbigående blodprop i hjernen.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to investigate whether simvastatin in 3 different doses can cause peripheral neuropathy after 6 months of treatment assessed by nerve conduction, quantitative sensory testing and quantification of nerve fiber density in the dermo-epidermal transition.
    Formålet med studiet er at undersøge om simvastatin i 3 forskellige doser kan give perifer neuropati efter 6 måneders behandling bedømt ved nerveledning, kvantitativ sensorisk testning og kvantitering af nervefibertæthed i den dermo-epidermale overgang.
    E.2.2Secondary objectives of the trial
    Not applicable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Admitted to Odense University Hospital at the Department of Neurology or the Common Emergency Department at Neurology level.
    - Age: 40-80 years.
    - Newly diagnosed cerebral infarction or transient ischemic attack from clinical point of view and / or CT / MRI verification.
    For the treatment group applies:
    - In relation to the infarction the patients are in need of preventive statin therapy according to the guidelines of the department.
    For the control group applies:
    - In relation to the infarction the patients are not in need of preventive statin therapy according to the guidelines of the department or the patient does not want treatment.
    - Indlagt på Odense Universitetshospitals Neurologisk Afdeling eller hospitalets Fælles Akut Modtagelse i Neurologisk regi.
    - Alder: 40-80 år.
    - Nydiagnosticeret cerebralt infarkt eller TIA ud fra sikker klinik og/eller CT/MR-verifikation.
    For behandlingsgruppen gælder:
    - I relation til infarktet vurderes patienten at have behov for forebyggende statinbehandling ud fra afdelingens instruks.
    For kontrolgruppen gælder:
    - I relation til infarktet vurderes patienten ikke at have behov for forebyggende statinbehandling ud fra afdelingens instruks eller patienten ønsker ikke behandlingen.
    E.4Principal exclusion criteria
    - Previous or current treatment with statins ( simvastatin , atorvastatin, rosuvastatin , fluvastatin , lovastatin and pravastatin ) .
    - Contraindications against statin therapy .
    - Current or previous treatment with drugs with known neurotoxic effects.
    - Current or previous co-morbidities that may cause polyneuropathy such as diabetes mellitus , cancer, disease , AIDP , CIDP , connective tissue diseases (ex. Sjogren 's syndrome, SLE , etc. . ), Vitamin B12 deficiency , hypothyroidism, myelomatosis , alcohol overuse (> 21 units for men and 14 units for women respectively per week ) , etc. . Furthermore patients who are being investigated for the same are being excluded.
    - Pre-existing peripheral neuropathy diagnose or symptoms suggestive of peripheral neuropathy
    - Patients with hypertriglyceridemia (> 10 mmol / l) .
    - Bilateral symptomatic cerebral infarcts , where one or both extremities are involved bilaterally , or other neurological disease which obviously will lead to sources of error in assessment with neuropathy rating scales.
    - High NIHSS if it is expected to result in a lasting , severe functional impact.
    - Aphasia , which makes an adequate information base for consent impossible.
    - Other neuropsychological sequelae than aphasia that makes the patient incapable of understanding the given information sufficiently.
    - Tidligere eller aktuel behandling med statiner (simvastatin, atorvastatin, rosuvastatin, fluvastatin, lovastatin og pravastatin).
    - Kontraindikationer mod statinbehandling.
    - Aktuel eller tidligere behandling med lægemidler med kendt neurotoksisk effekt.
    - Aktuel eller tidligere co-morbiditeter, der kan give polyneuropati så som diabetes mellitus, cancer sygdom, AIDP, CIDP, bindevævssygdomme (ex. Sjøgren syndrom, SLE mv.), vitamin B12-mangel, hypothyroidisme, myelomatose, kendt alkoholoverforbrug (> hhv. 21 genstande for mænd og 14 genstande for kvinder ugentligt) mv. Desuden eksluderes patienter, der er under udredning for samme.
    - Kendt diagnose med perifer neuropati eller i forvejen bestående symptomer tydende på perifer neuropati.
    - Patienter med hypertriglyceridæmi (>10 mmol/l).
    - Bilaterale symptomatiske cerebrale infarkter, hvor en eller begge ekstremiteter er involverede bilateralt, eller anden neurologisk sygdom, der åbenlyst vil medføre fejlkilder ved vurdering med benyttede neuropati-ratingsskalaer.
    - Høj NIHSS såfremt, det forventes at medføre en varig, svær funktionspåvirkning.
    - Afasi, der umuliggører et tilstrækkelig informationsgrundlag for samtykke.
    - Andre neuropsykologiske sequelae end afasi, der gør, at patienten vurderes ikke at kunne forstå den givne information i tilstrækkelig grad.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be nerve fiber density and nerve conduction assessed by the amplitude of the sensory action potential and conduction velocity in the sural nerve, amplitude of motor action potential and conduction velocity of the peroneal nerve and minimal F-wave latency in the tibial nerve.
    De primære effektvariable vil være nervefibertæthed samt nerveledning vurderet ved amplitude af sensorisk aktionspotentiale og ledningshastighed i n. suralis, amplitude af motorisk aktionspotentiale og ledningshastighed i n. peroneus, samt minimal F-wave latens i n. tibialis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessments are made before and after 6 months of treatment.
    Der måles før og efter 6 måneders behandling.
    E.5.2Secondary end point(s)
    Other variables are secondary.
    Øvrige variable betragtes som sekundære.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessments are made before and after 6 months of treatment.
    Der måles før og efter 6 måneders behandling.
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    The aim is to investigate whether simvastatin can cause peripheral neuropathy as a side effect.
    Formålet er at undersøge om simvastatin kan give perifer neuropati som bivirkning.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Forskellige dosis-niveauer.
    Different dose levels.
    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
    Forskellige dosis-niveuaer + "Kontrolgruppen" får ikke nogen behandling.
    Diffenrent dose levels + The "control group" does not receive any treatment.
    E.8.2.4Number of treatment arms in the trial4
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The trial will end when 45 patients in each group (including the control group) has completed.
    Forsøget vil afsluttes, når 45 patienter i hver gruppe (inklusiv kontrolgruppen) har gennemført.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-02-27. Yes
    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 state180
    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 the study the simvastatin dose will for all subjects be 40 mg/day after individuel assessment.
    Efter studiet vil alle forsøgspersoners simvastatin-dosis rettes ind til 40 mg/dag efter individuel vurdering.
    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 Decision2014-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-03-25
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