Diffuse scleroderma MedDRA version: 12.1 Level: LLT Classification code 10012941 Term: Diffuse scleroderma
Conditions
Interventions
Product Name: Terguride
Product Code: PR1
Pharmaceutical Form: Tablet
INN or Proposed INN: Terguride
CAS Number: 37686-84-3
Current Sponsor code: -
Other descriptive name: transdihydrolisuride
Concent
Sponsors
University Hospital Zurich
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients of age between > 18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 Major surgery within two months prior to treatment start 2 Any of the following abnormal baseline hematological values • Hb 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess in patients with diffuse scleroderma the effects of the serotonin receptor antagonist Terguride on established biomarkers of the disease.;Primary 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).;Secondary Objective: 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). | — |
Countries
Germany
Outcome results
None listed