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New treatment option for Graves Ophthalmopathy
Official title Treatment of Graves´ophthalmopathy with Simvastatin (GO-S)
ClinicalTrials.gov ID: NCT03131726
What this study is testing
What is Simvastatin 40mg?
Simvastatin 40mg is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for graves ophthalmopathy.
Also referred to as ATC-code: C10AA01.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age 18-70 years
- Active mild to moderate with at least one sign of mild GO (NO SPECS class 2a and b) with reference to Colour Atlas at EUGOGO website (www.eugogo.eu)...
- Graves´ disease with clinical and laboratory euthyroidism after stopping treatment with anti thyroid drugs (ATD), or 2 months treatment with ATD, or...
You likely can't join if
- Pregnancy or breast-feeding
- Previous treatment of Graves´ ophthalmopathy
- Severe Graves ophthalmopathy requiring corticosteroid treatment, retrobulbar irradiation, orbital decompression surgery
- Current or previous treatment with simvastatin or other statins (within 3 months)
- Allergy (skin rash or systemic reactions) to statins
- Congestive heart failure
See the full eligibility criteria
- Age 18-70 years
- Active mild to moderate with at least one sign of mild GO (NO SPECS class 2a and b) with reference to Colour Atlas at EUGOGO website (www.eugogo.eu). Exophthalmos up to 24 mm with a disease duration of \<18 months (as...
- Graves´ disease with clinical and laboratory euthyroidism after stopping treatment with anti thyroid drugs (ATD), or 2 months treatment with ATD, or euthyroid 6 months after treatment with radioiodine, or euthyroid...
- Pregnancy or breast-feeding
- Previous treatment of Graves´ ophthalmopathy
- Severe Graves ophthalmopathy requiring corticosteroid treatment, retrobulbar irradiation, orbital decompression surgery
- Current or previous treatment with simvastatin or other statins (within 3 months)
- Allergy (skin rash or systemic reactions) to statins
- Congestive heart failure
- Renal insufficiency (glomerular filtration rate \<60 ml/min)
- ASAT or ALAT \> 2.5 times the upper limit of the local laboratory
- Alcoholism as judged by local criteria
- Coagulopathy including treatment with warfarin or new oral anti-coagulation drugs
- Previous or current gastric ulcer
- Inflammatory bowel disease diabetic retinopathy or nephropathy
- Trauma within 10 days
The study team makes the final eligibility decision.
Where it's taking place
- Malmö, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Malmö, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.