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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41465   clinical trials with a EudraCT protocol, of which   6815   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2010-024005-13
    Sponsor's Protocol Code Number:3098009
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-12-30
    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 ConcernedUK - MHRA
    A.2EudraCT number2010-024005-13
    A.3Full title of the trial
    Efficacy of ORM-12741 for prevention of cold-induced vasospasm; a randomised, double-blind, placebo-controlled, single centre crossover study in patient with Raynaud's phenomenon secondary to systemic sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of ORM-12741 for the prevention of blood vessel spasm brought on by cold temperature.
    A.3.2Name or abbreviated title of the trial where available
    Reino
    A.4.1Sponsor's protocol code number3098009
    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 SponsorOrion Corporation Orion Pharma
    B.1.3.4CountryFinland
    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 supportOrion Corporation Orion Pharma
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOrion Corporation Orion Pharma
    B.5.2Functional name of contact pointAngela Ruck
    B.5.3 Address:
    B.5.3.1Street Address2-4 Weekday Cross Fletcher Gate
    B.5.3.2Town/ cityNottingham
    B.5.3.3Post codeNG1 2GB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441159487138
    B.5.5Fax number00441159487139
    B.5.6E-mailclinicaltrials@orionpharma.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 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 nameORM-12741
    D.3.2Product code ORM-12741
    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.3.9.2Current sponsor codeORM-12741
    D.3.9.3Other descriptive namealpha-2C AR antagonist
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 nameORM-12741
    D.3.2Product code ORM-12741
    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.3.9.2Current sponsor codeORM-12741
    D.3.9.3Other descriptive nameAlpha-2C AR antagonist
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Raynaud's phenomenon secondary to systemic sclerosis (Raynaud's syndrome)
    E.1.1.1Medical condition in easily understood language
    Blood vessel spasm brought on by cold temperature in patients with Raynauds phenomenon secondary to systemic sclerosis.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10037914
    E.1.2Term Raynaud's syndrome
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of ORM-12741 in the attenuation of a cold-induced reduction in finger blood flow and temperature in subjects with Raynaud's Phenomenon (RP) secondary to systemic sclerosis in a controlled environment.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of ORM-12741 in subjects with RP secondary to systemic sclerosis, and to assess dose-response relationship in terms of the effect on finger blood flow and temperature.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Written informed consent (IC) obtained.
    2.Age of 18-75 years (inclusive).
    3.Body mass index (BMI) between 18-30 kg/m2 (inclusive).
    4.Male or female patients with a diagnosis of active RP secondary to systemic sclerosis. Active RP will be defined as a history of cold sensitivity associated with colour changes of cyanosis or pallor, as well as of at least 2 attacks daily or at least 6 attacks weekly during the winter months. Diagnosis of systemic sclerosis will be defined by The European League Against Rheumatism (EULAR) criteria (Matucci-Cerinic M et al., 2009).
    5.Stable symptoms for RP and medication requirements within 2 months prior to screening.
    6.Negative pregnancy test for females of childbearing potential.
    E.4Principal exclusion criteria
    1.Treatment with nitrates.
    2.Changes in dosing of calcium channel blockers (CCBs) within 1 month prior to the screening or during the study.
    4.Changes in dosing of other vasoactive medications within 1 month prior to the screening or during the study.
    5.Inability to refrain from smoking for at least 12 hours prior to and during the treatment visits.
    6.Current active ischemic digital ulcer and/or tissue gangrene.
    7.History of sympathectomy.
    8.Upper extremity deep vein thrombosis or lymphoedema within 3 months prior to screening.
    9.Clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, psychiatric, or malignant disorder or any other major concurrent illness that in the opinion of the investigator would interfere with the interpretation of the study results or constitute a health risk for the subject if he/she takes part into the study.
    10.Supine HR > 100 bpm after a 10-minute rest at screening visit.
    11.Supine systolic BP (SPB) > 160 or diastolic BP (DPB) > 100 mmHg after a 10-minute rest at screening visit.
    12.Any other abnormal value of laboratory, vital signs or electrocardiogram (ECG) which may in the opinion of the investigator interfere with the interpretation of the study results or cause health risk for the subject if he/she takes part into the study.
    13.Pregnant or breast feeding or considering pregnancy in the next 4 months.
    14.Female subjects of childbearing potential (i.e. menstruating or less than 2 years postmenopausal) if they are not using proper contraception (hormonal contraception, intrauterine device (IUD) or surgical sterilisation, spermicidal foam in conjunction with condom on male partner).
    15.Subjects with pre-planned elective surgery during the estimated study period.
    16.Blood donation or loss of significant amount of blood within 30 days prior to the screening.
    17.Participation in a drug study within 30 days prior to the screening.
    18.Known hypersensitivity to the active substance or to any excipients of the drug.
    19.Recent or current (suspected) drug abuse.
    20.Recent or current alcohol abuse (regular drinking more than 14 units per week for females or 21 units per week for males; 1 unit = 4 cl spirits or equivalent).
    21.Inability to refrain from consuming caffeine-containing beverages for at least 12 hours prior to and during the treatment visits e.g. propensity in getting headache when refraining from caffeine-containing beverages.
    22.Inability to participate in all treatment periods.
    23.Unsuitable veins for repeated venipuncture or for cannulation.
    24.The subject is not able to swallow test capsule at screening visit.
    25.Any other condition that in the opinion of the investigator would interfere with the interpretation of the study results or constitute a health risk for the patient if he/she takes part in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Effects of treatments on finger blood flow will be assessed by measuring finger temperature and skin blood flow index by Laser Doppler Imaging (LDI).
    Continuous raw data from the finger temperature and LDI measurements will then be transformed to the following variables:
    •area above the time-response curve,
    •minimum measurement,
    •time to minimum measurement,
    •time to recovery of 70% of the baseline measurement, and rates of change in temperature and blood flow during decrease and recovery.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measurement of the finger temperature and skin blood flow index by Laser Doppler imaging (LDI) at baseline before treatment, baseline after treatment, during exposure to cold challenge and during recovery
    E.5.2Secondary end point(s)
    The concentrations of adrenaline and noradrenaline in plasma will be determined in order to assess response to the cold challenge and the study treatment (PD).
    Concentrations of ORM-12741 and the major metabolite ORM-13720 in plasma will be determined (PK).
    Assessment of safety and tolerability.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK & PD before the IMP dosing, 31 min. after dosing and 91 min. after dosing.
    Safety and tolerability until the end-of study visit
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 trial3
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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 visit of the last subject undergoing the trial
    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 months5
    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 months5
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state12
    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)
    As per protocol
    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 Decision2011-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-12-14
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