Prospective Evaluation of OptiThyDose

Sponsor
University Children's Hospital Basel
Study ID
NCT06864351
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • OptiThyDose — OTHER
    OptiThyDose is an iterative mathematical model applied at each patient visit, consisting of three components: (i) a disease-specific pharmacometrics (PMX) model, (ii) an empirical Bayesian estimation (EBE) component, and (iii) an optimal control theory (OCT) component. It calculates the optimal LT4 or CMZ/MMZ dose to maintain Free Thyroxine (FT4) levels within the upper half of the age-specific reference range, integrating past clinical and lab data. Dosing follows international guidelines, with physicians able to consult OptiThyDose for individualized dosing within recommended ranges. At each outpatient visit, the physician can either (A) prescribe a dose within OptiThyDose's suggested range or (B) choose a dose based on personal experience.

Study Details

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).

Key Dates

Start date
Aug 28, 2025
Status verified
Sep 2025
Primary completion
May 31, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control group w/ Congenital Hypothyroidism
    Patients with Congenital Hypothyroidism receiving routine levothyroxine (LT4) treatment
  • Experimental: OptiThyDose w/ Congenital Hypothyroidism
    Patients with Congenital Hypothyroidism receiving routine levothyroxine (LT4) treatment
  • No Intervention: Control group w/ Graves' Disease
    Patients with Graves' Disease receiving routine carbimazole (CMZ) or methimazole (MMZ) treatment
  • Experimental: OptiThyDose w/ Graves' Disease
    Patients with Graves' Disease receiving routine carbimazole (CMZ) or methimazole (MMZ) treatment

Primary Outcome Measure

Serum Free Thyroxine (FT4) value [ Time Frame: 90 days post treatment start ]

Central Contacts

Related Studies