Study of Terguride Plus Symptomatic Therapy in patients with dcSSc
Research type
Research Study
Full title
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 (TERGISS)
IRAS ID
207414
Contact name
Christopher Paul Denton
Contact email
Sponsor organisation
medac GmbH
Eudract number
2015-002586-39
Duration of Study in the UK
3 years, 2 months, 10 days
Research summary
Medac GmbH is conducting this study to investigate if a drug called Terguride is safe and effective in the treatment of diffuse cutaneous systemic sclerosis (dcSSc). dcSSC is an autoimmune disease of which outward signs are thickening and hardening of the skin. This form of the disease can also result in hardening of internal organs which can lead to problems in the lungs, kidneys, heart, digestive system, and other areas. \nAt present there are no approved drugs for the treatment of dcSSC and there is no cure. Current approved treatments are aimed at slowing progression and relieving symptoms. Terguride is approved in Japan for the treatment conditions related to excess prolactin. To date, over 200,000 people have been treated and side effects are known. A recent study showed that Terguride may be of benefit to people with dcSSc and further research is needed to confirm this.\nIn this study participants will receive Terguride as an oral tablet. For 12 months participants will receive either Terguride or placebo, neither patient or doctor will know which they are receiving. In the second year all participants will receive Terguride. Prior to both phases, participants will have 4 weeks of taking Terguride at different doses to determine the highest individually well-tolerated dose. Individuals metabolise Terguride differently therefore the total daily dose will be tailored to the participant.\nIt is expected that approximately 148 male and female participants, over 18 with dcSSC, will take part in this study worldwide with approximately 8 participants being recruited at 3 hospital sites in the UK. The duration of participation is expected to be 26.5 months with approximately 13 clinic visits and phone contacts between visits. Procedures include blood and urine samples, ECG, physical examinations, gynaecological examinations , patient diary and questionnaires. There are optional pharmacokinetic and skin biopsy sub-studies.\n\n
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
16/LO/1555
Date of REC Opinion
18 Oct 2016
REC opinion
Further Information Favourable Opinion