Taking peopleNo phase
Prospective Evaluation of OptiThyDose
Key facts
- Who runs it
- University Children's Hospital Basel
- Where
- Paris, FranceSee the siteAlso in 2 other countries, 6 sites
- Trial code
- Status
- Recruiting
- People taking part
- 150 people, planned
- Started
- 28 Aug 2025
- Expected to end
- Feb 2029
- Type of study
- Interventional, 4 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- OptiThyDose
- Record updated
- 2 October 2026
Who can take part
- Age
- Up to 18 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Congenital hypothyroidism (CH)
- Newborns with pathological neonatal screening and confirmation of an increased Thyrotropin (TSH) level in an independent venous blood sample; Graves' disease (GD)
- Children until 18 years with new diagnosis of GD, recurrence of GD, or insufficiently controlled GD under CMZ/MMZ during follow-up according to:; Pathological lab values (suppressed TSH, increased thyroid hormone levels, positive Anti-TSH-receptor antibodies); Typical clinical picture, if present (goitre, tachycardia, palpitations, weight loss, hyperphagia, altered mood); CH and GD
- The study participant must be accessible for scheduled visits, treatment and follow-up
- Signed Informed Consent form (ICF) obtained prior to any study related procedure. Written IC for study participation must be signed and dated by the patient and/or his/her legal representative(s) in accordance with national legal requirements
Who cannot take part
- Exclusion of children with known other aetiologies of hyperthyroidism than GD without elevated Anti-TSH-receptor antibodies e.g.:; known toxic thyroid nodules proven by ultrasound/scintigraphy; known amiodarone induced hyperthyroidism; known McCune Albright syndrome (based on clinical, laboratory, and genetic diagnosis) associated hyperthyroidism; known genetically proven hyperthyroidism caused by activating mutations of the TSH receptor gene
- CH and GD
- Exclusion of newborns from mothers with GD
- Exclusion of patients in case of a life-threatening event; GD
Where in France
Also in 2 other countries, 6 sites
- Department of Paediatric Endocrinology, Diabetology and Gynaecology, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de ParisParis, FranceContact: Gabor Szinnai, Prof. MD, PhDNot yet recruiting
About the trial
What the trial wants to find out
The aim of this multicentric, randomised, two-arms and single-blinded clinical trial is to prospectively evaluate OptiThyDose for Congenital hypothyroidism (CH) and Graves' disease (GD).
The 4 groups in the trial
- Control group w/ Congenital HypothyroidismNo study treatment, for comparison
Patients with Congenital Hypothyroidism receiving routine levothyroxine (LT4) treatment
- OptiThyDose w/ Congenital HypothyroidismTreatment being tested
Patients with Congenital Hypothyroidism receiving routine levothyroxine (LT4) treatment
Treatment: OptiThyDose
- Control group w/ Graves' DiseaseNo study treatment, for comparison
Patients with Graves' Disease receiving routine carbimazole (CMZ) or methimazole (MMZ) treatment
- OptiThyDose w/ Graves' DiseaseTreatment being tested
Patients with Graves' Disease receiving routine carbimazole (CMZ) or methimazole (MMZ) treatment
Treatment: OptiThyDose
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective Evaluation of OptiThyDose, a Mathematical Model for Calculating Appropriate Dose Ranges in Children With Thyroid Diseases
- Record updated
- 2 October 2026