Actively Recruiting
Treatment of Graves´ophthalmopathy with Simvastatin (GO-S)
Led by Lund University · Updated on 2024-09-25
80
Participants Needed
1
Research Sites
530 weeks
Total Duration
On this page
Sponsors
L
Lund University
Lead Sponsor
R
Region Skane
Collaborating Sponsor
AI-Summary
What this Trial Is About
In an investigator initiated multicenter trial (Malmö, Odense, Århus) the investigators aim at evaluating activity of Graves´ophthalmopathy (GO) and progress to severe GO in patients with mild to moderate Graves´ ophthalmopathy treated with simvastatin or no treatment.
CONDITIONS
Official Title
Treatment of Graves´ophthalmopathy with Simvastatin (GO-S)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Active mild to moderate Graves' ophthalmopathy with at least one mild sign (NO SPECS class 2a or 2b)
- Exophthalmos up to 24 mm with disease duration less than 18 months
- Graves' disease with clinical and laboratory euthyroidism achieved by stopping or using anti-thyroid drugs, radioiodine treatment 6 months prior, or thyroidectomy
- Euthyroidism confirmed by normal fT4, fT3 and TSH below local upper limit during study period
You will not qualify if you...
- Pregnancy or breastfeeding
- Previous treatment for Graves' ophthalmopathy
- Severe Graves' ophthalmopathy needing corticosteroids, irradiation, or orbital decompression surgery
- Current or past use of simvastatin or other statins within 3 months
- Allergy to statins
- Congestive heart failure
- Kidney insufficiency with glomerular filtration rate below 60 ml/min
- Elevated liver enzymes (ASAT or ALAT more than 2.5 times upper limit)
- Alcoholism by local criteria
- Blood clotting disorders or use of anticoagulant medications
- Previous or current gastric ulcer
- Inflammatory bowel disease, diabetic retinopathy, or diabetic nephropathy
- Trauma within 10 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dpt. of Endocrinology, SUS Malmö
Malmö, Sweden
Actively Recruiting
Research Team
T
Tereza Planck, MD, PhD
CONTACT
S
Sabina Andersson, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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