Prospective Randomized Clinical Trial of Total Thyroidectomy (Tx) versus Anti-Thyroid Drugs (ATD) in Patients with Moderate-to-Severe Graves’ Ophthalmopathy - a 1-year Follow-up

Prospective Randomized Clinical Trial of Total Thyroidectomy (Tx) versus Thionamides (Anti-Thyroid Drugs) in Patients with Moderate-to-Severe Graves’ Ophthalmopathy - a 1-year Follow-up - TX vs ATD in moderate-to-severe GO

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003515-38-AT

Enrollment

Registered

2015-09-30

Start date

2016-02-23

Completion date

Unknown

Last updated

2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graves' disease, hyperthyroidism

Interventions

Trade Name: Thiamizol Pharmaceutical Form: Tablet INN or Proposed INN: METHIMAZOLE CAS Number: 60-56-0 Other descriptive name: THIAMAZOLE Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) GD and GO onset 3/7) 8) informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1) GD and GO onset > 12 months 2) more than one relapse of GO longer than 6 months from diagnosis 3) previous GD treatment by RAI or surgery 4) SNI greater than 7.0 5) urgent orbital decompression surgery 6) loss of vision 7) loss of visual field 8) loss of color vision 9) patients not receiving glucocorticoids for GO 10) cytological findings of postsurgical histopathological results suspicious for malignancy 11) pregnancy or breast-feeding 12) contraindication to GC 13) halt of GC therapy 14) age below 18 years 15) no informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine the difference in the outcome of GO in patients with moderate-to-severe GO, who receive Tx versus further ATD after suffering their first relapse following the initial decrease in ATD after 6 months. Establish a glucocorticoid scheme before and after Tx in patients with moderate-to-severe EO. The difference will primarily be measured in terms of the Muscle Index score determined through an ultrasound.;Secondary Objective: Clinical Activity Score, Superonasal Index Ultrasound, Thyroid antibodies, Quality of life score;Primary end point(s): Parameters of CAScore/NOSPECS score, Superonasal index (SNI), muscle index (MI) from ultrasound measurements (at 6 months, at 12 months);Timepoint(s) of evaluation of this end point: At 12 months following therapy	—

Measure

Time frame

Main Objective: To examine the difference in the outcome of GO in patients with moderate-to-severe GO, who receive Tx versus further ATD after suffering their first relapse following the initial decrease in ATD after 6 months. Establish a glucocorticoid scheme before and after Tx in patients with moderate-to-severe EO. The difference will primarily be measured in terms of the Muscle Index score determined through an ultrasound.;Secondary Objective: Clinical Activity Score, Superonasal Index Ultrasound, Thyroid antibodies, Quality of life score;Primary end point(s): Parameters of CAScore/NOSPECS score, Superonasal index (SNI), muscle index (MI) from ultrasound measurements (at 6 months, at 12 months);Timepoint(s) of evaluation of this end point: At 12 months following therapy

—

Secondary

Measure	Time frame
Secondary end point(s): Thyroid antibodies, Quality of life score;Timepoint(s) of evaluation of this end point: 12 months	—

Countries

Austria

Contacts

Public ContactDr. Lindsay Brammen

Medical University Vienna

lindsay.brammen@meduniwien.ac.at4314040056210

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026