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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:2009-017869-27
    Sponsor's Protocol Code Number:TERSSC-001 incl. Amendment 1
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-07-14
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-017869-27
    A.3Full title of the trial
    A dual-center, open-label Proof of Concept study to evaluate the efficacy of Terguride for the treatment of fibrosis in patients with systemic sclerosis.
    A.4.1Sponsor's protocol code numberTERSSC-001 incl. Amendment 1
    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 SponsorUniversity Hospital Zurich
    B.1.3.4CountrySwitzerland
    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 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTerguride
    D.3.2Product code PR1
    D.3.4Pharmaceutical form Tablet
    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.3.8INN - Proposed INNTerguride
    D.3.9.1CAS number 37686-84-3
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nametransdihydrolisuride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diffuse scleroderma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10012941
    E.1.2Term Diffuse scleroderma
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess in patients with diffuse scleroderma the effects of the serotonin receptor antagonist Terguride on established biomarkers of the disease.
    E.2.2Secondary objectives of the trial
    1 To assess the safety of Terguride in SSc patients.
    2 To assess improvement in skin fibrosis as assessed by the modified Rodnan skin score.
    3 To assess improvement on quality of life using the Scleroderma Health Assessment Questionnaire (SHAQ).
    4 To assess the improvement in lung functions as measured by CO diffusion capacity (DLCO) and Forced Vital Capacity (FVC).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients of age between > 18 and < 75 years
    2. Patients fulfilling the American College of Rheumatology criteria for systemic sclerosis (SSc)
    3. Diffuse cutaneous SSc (dcSSc) according to the LeRoy criteria
    4. Female patients of child bearing potential must be using a double-barrier local contraception, i.e. intra-uterine device plus spermicidal gel, or spermicidal gel plus condom up to Study Completion visit
    5. Male patients must be using a double-barrier local contraception, i.e., spermicidal gel plus condom, for the entire duration of the study, up to Study Completion visit
    6. Capability of understanding the nature of the study and giving written informed consent
    7. Willingness and ability to comply with the study protocol for the duration of the study
    E.4Principal exclusion criteria
    1 Major surgery within two months prior to treatment start
    2 Any of the following abnormal baseline hematological values
    • Hb < 10g/dl
    • WBC < 3.0 x 10^9/l
    • Neutrophils < 1.5 x 10^9/l
    • Platelets < 100 x 10^9/l
    3 Any of the following abnormal baseline liver function tests:
    • Serum bilirubin > 2.0 x upper normal limit
    • ALAT and/or ASAT > 5.0 x upper normal limit
    4 The following abnormal baseline renal function test:
    • Serum creatinine > 1.5 mg/dl
    • Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault criteria:
    [CLcrea = Weight (kg) x (140 – Age)/72 x serum creatinine concentration]
    For male: x 1, for female: × 0.85
    5 Renal crisis (acute onset of renal failure, moderate to marked hypertension, and normal urine sediment with mild proteinuria) in the 2 months prior to treatment
    6 All Cardiovascular: clinically relevant abnormalities, i.e. myocardial infarction within the prior six months, cardiac arrhythmia requiring medication, evidence of fibrosis on heart valves, or uncontrolled hypertension
    7 Abnormal cardiac function or non compensated active heart disease (* class II of NYHA classification)
    8 Lung
    • FVC < 50% predicted
    • CO diffusion capacity < 40% predicted
    9 Gut
    • Pseudo obstruction
    • Malabsorption requiring parenteral nutrition
    10 History of psychiatric disabilities, seizures or central nervous system disorders thought to be clinically relevant in the opinion of the Investigator that could interfere with informed consent or adequate follow-up
    11 Treatment with other potentially disease modifying agents during the last 3 months, including prednisone or corticosteroid equivalent in doses higher than 15 mg/d. Doses of prednisone lower than 15 mg/d are allowed
    12 Serious (grade 3-4) uncontrolled intercurrent infections
    13 Evidence or history of drug or alcohol abuse
    14 Participation in any investigational drug study within 60 days preceding treatment start or during the study
    15 Pregnancy or breast feeding women
    16 Any condition which in the judgment of the Investigator would place the subject at undue risk or interfere with the results of the study
    E.5 End points
    E.5.1Primary end point(s)
    Primary activity endpoints are changes of biomarkers from skin biopsies and plasma and serum biomarkers at the EOS-visit compared to baseline (Day 0).
    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 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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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 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
    provided in the protocol
    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 months10
    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 months10
    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 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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7
    F.4.2.2In the whole clinical trial 14
    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 period, the participants will be treated according to the current standard of care as before.
    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 Decision2010-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-22
    P. End of Trial
    P.End of Trial StatusOngoing
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