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    The EU Clinical Trials Register currently displays   43801   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:2015-002586-39
    Sponsor's Protocol Code Number:MC-TER.2/SSc
    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:2016-07-19
    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 number2015-002586-39
    A.3Full title of the trial
    Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to
    Evaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapy
    in Subjects With Diffuse Cutaneous Systemic Sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis
    A.3.2Name or abbreviated title of the trial where available
    TERGISS
    A.4.1Sponsor's protocol code numberMC-TER.2/SSc
    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 Sponsormedac GmbH
    B.1.3.4CountryGermany
    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 supportmedac GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationmedac GmbH
    B.5.2Functional name of contact pointProject Manager Clinical Research
    B.5.3 Address:
    B.5.3.1Street AddressTheaterstrasse 6
    B.5.3.2Town/ city Wedel
    B.5.3.3Post codeD 22880
    B.5.3.4CountryGermany
    B.5.4Telephone number494103 8006 434
    B.5.5Fax number494103 8006 422
    B.5.6E-mailc.guimbal-schmolck@medac.de
    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 numberEMA/OD/153/12
    D.3 Description of the IMP
    D.3.1Product nameTerguride
    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 INNTERGURIDE HYDROGENMALEATE
    D.3.9.1CAS number 37686-85-4
    D.3.9.4EV Substance CodeSUB04725MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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 Yes
    D.3.11.13.1Other medicinal product typeSemisynthetic ergot alkaloide, which was developed as dopaminergic agent and approved as drug for various indications
    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 numberEMA/OD/153/12
    D.3 Description of the IMP
    D.3.1Product nameTerguride
    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 INNTERGURIDE HYDROGENMALEATE
    D.3.9.1CAS number 37686-85-4
    D.3.9.4EV Substance CodeSUB04725MIG
    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 Yes
    D.3.11.13.1Other medicinal product typeSemisynthetic ergot alkaloide, which was developed as dopaminergic agent and approved as drug for various indications
    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 placeboTablet
    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
    Diffuse cutaneous systemic sclerosis (dcSSc)
    E.1.1.1Medical condition in easily understood language
    systemic sclerosis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10042953
    E.1.2Term Systemic sclerosis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the efficacy of terguride compared to placebo in terms of absolute change in the mRSS during the double-blind treatment phase in subjects with dcSSc.
    E.2.2Secondary objectives of the trial
    The secondary and other objectives include the following:
    • To assess the efficacy of terguride compared to placebo in terms of impact on skin thickening, visceral involvement, functional status, quality of life, and pharmacodynamic parameters during the double-blind treatment phase.
    • To assess the safety of terguride compared to placebo in a 52-week double-blind treatment phase.
    • To assess the efficacy and safety of terguride in the open-label, 52-week open-label extension phase.
    • To assess the prognostic value of CYP2D6 polymorphism with regard to the HIwT terguride dosage.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each subject must meet all of the following criteria to be enrolled in this study (criterion #7 must also be met for inclusion in the open-label extension phase of the study):
    1. Is a male or female ≥18 years of age.
    2. Fulfills the ACR/EULAR 2013 criteria for classification of SSc
    3. Has diffuse cutaneous involvement (defined by skin fibrosis in at least 1 of the following sites: upper arms, thorax, abdomen, or thighs) according to scleroderma classification criteria (LeRoy et al 1988), confirmed independently by a second investigator who is unaware of the assessment of the first investigator.
    4. Has a baseline mRSS between 10 and 25 units, inclusive.
    5. Has had onset of the first non-Raynaud’s manifestation of SSc within 36 months of screening.
    6. Is willing and able to comply with all aspects of the study; in particular, has the ability to attend study visits and assessments at least until the end of the double-blind treatment phase.
    7. If a male subject is capable of reproduction or a female subject is of childbearing potential, he/she consents to practice sexual abstinence (Sexual abstinence refers to refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The reliabilty of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.) or use another highly effective method of contraception (Pearl index < 1), such as combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone releasing system, bilateral tubal occlusion or vasectomy in combination with a second method of contraception, such as a condom or a cervical cap/diaphragm with spermicide, during the trial and for at least 6 months thereafter.
    8. Has provided written informed consent.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria will be excluded from the study:
    1. Has abnormal hematological values prior to baseline (Visit 2).
    2. Has abnormal liver function tests prior to baseline (Visit 2).
    3. Has abnormal renal function tests prior to baseline (Visit 2).
    4. Has any known renal crisis history.
    5. Has cardiac abnormalities at screening (Visit 1).
    6. Has any of the following lung criteria at screening (Visit 1):
    • Forced vital capacity (FVC) <40% predicted
    • Diffusing capacity of the lung for carbon monoxide (DLCO) <30% predicted.
    7. Has a previous diagnosis of severe pulmonary arterial hypertension (PAH).
    8. Has malabsorption requiring parenteral nutrition at screening (Visit 1).
    9. Has had treatment with putative disease-modifying agents within 8 weeks of screening.
    10. Has had treatment with cyclophosphamide within 26 weeks of screening (Visit 1).
    11. Has had treatment with rituximab within 52 weeks of screening (Visit 1).
    12. Has a known acute or uncontrolled chronic infection (eg, hepatitis B or C, tuberculosis, or human immunodeficiency virus [HIV]).
    13. History of hematopoietic stem cell transplantation or planned hematopoietic stem cell transplantation within the next 12 months, or total lymphoid irradiation.
    14. Has any concurrent medical condition(s) that, in the opinion of the investigator, may confound the results of the study.
    15. Is pregnant or lactating.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the absolute change in mRSS between baseline and Week 52 of the double-blind treatment phase.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52 of double blind phase
    E.5.2Secondary end point(s)
    • The absolute change in total score of the HAQ-DI between baseline and Week 52 of the double-blind treatment phase.
    • The binary mRSS response defined as improvement of mRSS by at least 30% (relative) or 5 points (absolute) between baseline and Week 52 of the double-blind treatment phase.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52 of double blind phase
    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 Yes
    E.6.7Pharmacodynamic Yes
    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
    Quality of life
    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 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.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    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
    Belgium
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Portugal
    Romania
    Switzerland
    United Kingdom
    United States
    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
    The end of the study is defined as the date on which all subjects have completed, or have had the opportunity to complete, the safety visit (Visit 13).
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 134
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 148
    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)
    Patient’s care after end of trial participation will be left at the doctor’s discretion. Subjects who would like to remain on protocol-specified therapy after the open-label extension phase has been completed will be permitted to continue treatment at the investigator’s discretion, as provided for by the local country’s regulatory mechanisms. Data collection during this phase will be limited to administration of protocol-specified therapy and SAE reporting.
    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 Decision2016-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-06-05
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