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SOM230 Graves Orbitopathy pilot trial

SOM230 Graves Orbitopathy pilot trial - SOMGO

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38562
Enrollment
12
Registered
2013-07-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Graves Orbitopathy/Eye Disease

Interventions

Admnistration of SOM230 (Pasireotide)

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -moderate * severe GO -corticosteroids contraindicated due to diabetes mellitus (see below), severe osteoporosis, heart failure, psychosis, infectious diseases or other clinical relevant comorbidities -corticosteroids refused by patients -age > 18

Exclusion criteria

Exclusion criteria: -inability/refusal to give informed consent -pregnancy -GO (dysthyroid optical neuropathy) necessitating high dose steroids or acute decompression -abnormal thyroid function (defined as TSH >4.0 mU/l or FT4 21 pmol/l) -pregnancy -drug abuse and smoking.

Design outcomes

Primary

MeasureTime frame
Predefined combined clinical endpoints: see protocol.

Secondary

MeasureTime frame
n.a.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)