TEDDY is involved in the planning, designing, managing and conducting of preclinical studies and paediatric clinical studies (including innovative/traditional studies design, population PK, modeling, extrapolation, monitoring and statistical evaluation, recruitment governance, etc.).
The most important ongoing studies include:
Pharmacokinetics/Pharmacodynamics and safety/efficacy paediatric clinical trials
- DEEP-1: Multi-centre, oral single dose experimental and modelling PK study of deferiprone in children under six years of age. The study has been successfully completed with 18 children recruited
- DEEP-2: Open label, randomised, controlled, multicentre safety and efficacy active-controlled trial, comparing the efficacy of deferiprone versus deferasirox. The trial is ongoing and will involve paediatric patients starting from 1 month of age in 18 recruting sites
- NeoMero 1: Open label, randomised, multicentre, controlled study to evaluate the PK, efficacy and safety of meropenem as compared with standard antibiotic therapy in neonates and infants treated in neonatal intensive care units for late onset sepsis
- NeoMero 2: Open label, single arm, multicentre PK and safety study testing meropenem in neonates and infants with bacterial meningitis
- NeoVanc: Randomised controlled PK/PD study to compare the proportion of subjects reaching PD target and to evaluate safety and efficacy of vancomycin in children aged less than 3 months with late-onset neonatal sepsis
- GABA-1: Randomised, double-blind, active-controlled, multicentre trial to evaluate PK, efficacy and safety of gabapentin in children from 3 months to less than 18 years of age experiencing moderate chronic neuropathic or mixed chronic pain
- GABA-2: Randomised, double blind, placebo controlled, multi-centre trial to evaluate the safety, pharmacokinetic and efficacy of gabapentin as add-on to morphine in children from 3 months to less than 18 years of age suffering from severe chronic neuropathic or mixed pain
- Double-blind randomised, multicentre, active controlled trial to evaluate PK, safety and efficacy of clonidine for sedation in children from birth to less than 18 years of age
- Prospective multicentre randomised, placebo-controlled double-blind trial to verify the effects of the administration of probiotics on intestinal microflora in paediatric patients with Cystic Fibrosis
Non-interventional studies
- DEEP-3: Long-term observational safety study of deferiprone use in paediatric patients
Other studies
- Population pharmacokinetics meta-analysis based on all available published studies and data collected during clinical practice to determine the optimised dosage regimen of vancomycin to be used in children less than 3 months of age
- GABA-3: Model-based bridging of clinical data for children from 3 months to < 3 years to simulate PK/PD, clinical efficacy and safety data of gabapentin in children from 3 years to less than 18 years of age in chronic pain