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A Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study of Patient Reported Outcomes in Friedreichâ¤*s Ataxia Patients after withdrawal from Treatment with Idebenone (PROTI Study)

The primary objective of the PROTI study is to establish whether patients can correctly determine which treatment assignment they received during the randomised phase of the trial.The key secondary objective is to compare the rate of withdrawal from…

*Working memory training in children with neuropsychiatric disorders and borderline intellectual functioning*

1. To investigate the efficacy of Cogmed working memory training in reducing behavioral symptoms in children with neuropsychiatric disorders and borderline intellectual functioning.2. To investigate whether WM training improves neurocognitive…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multinational Clinical Study to Evaluate the Efficacy and Safety of 2.0 mg/kg/week and 2.0 mg/kg/every other week BMN 110 in Patients with Mucopolysaccharidosis IVA (Morquio A Syndrome)

This study will evaluate the efficacy and safety of 2.0 mg/kg/week and 2.0 mg/kg/every other week BMN 110 in patients with mucopolysaccharidosis IVA (Morquio A Syndrome). This study will compare the effects of 24 weeks of infusions of BMN 110 at…

Trial consisting of an 8-week double-blind placebo-controlled part to evaluate efficacy, safety, tolerability and pharmacokinetics of prucalopride in paediatric subjects with functional constipation, aged ???6 months to <18 years, followed by a 16-week open-label comparator (PEG) controlled part, to document safety and tolerability up to 24 weeks

The primary objective is to evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged *6 months to <18 years. Secondary objectives include:1. Investigation of the…

Multicenter, double-blind, placebo-controlled, randomized, prospective study of bosentan as adjunctive therapy to inhaled nitric oxide in the management of persistent pulmonary hypertension of the newborn (PPHN)

To assess the efficacy of bosentan in neonates with persistent pulmonary hypertension of the newborn (PPHN) who are in need of continued inhaled nitric oxide (iNO) after at least 4 hours of continuous iNO treatment and to evaluate the…

Fibrinogen therapy for massive blood loss during elective surgery for craniosynostosis repair, a double blinded randomized controlled study

Primary outcome parameter is the amount of intra- and postoperative transfusions required. Secondary outcome parameters include intra- and postoperative blood loss, operation time, and postoperative complications and the outcome of…

Beyond conventional treatment of Atopic eczema in infants: Management By specific prObiOtic strains. A double blind placebo-controlled trial.

To investigate the therapeutic effect of a selected probiotic mixture on the severity of AD in infants aged 0-15 months. The probiotic mixture has been studied in vitro and has proven IL-10 stimulating effects. Therefore it is thought to decrease AD…

A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 4 -16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES

The primary objective of this study is to evaluate the efficacy of 2 dose levels of pregabalin (Level 1: 2.5 mg/kg/day; maximum 150 mg day and Level 2: 10 mg/kg/day; maximum 600 mg day) compared to placebo as an adjunctive treatment in reducing the…

Efficacy of RAD001/everolimus in Autism and NeuroPsychological deficits in children with TSC (RAPIT-trial)

The objective of this study is to determine whether influencing the protein pathway thought to underlie TSC by Everolimus treatment will improve cognitive abilities in these children.

An efficacy, safety and pharmacokinetic study on the short-term and long-term use of METFORMIN in obese children and adolescents.

The primary objective of the METFORMIN study is to determine the efficacy of metformin in combination with lifestyle-intervention in obese children and adolescents with insulin resistance versus placebo with lifestyle-intervention. The secondary…

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Patients

The purpose of this current study is to evaluate the efficacy and safety of the 3-day oral aprepitant regimen when administered concomitantly with ondansetron, with or without dexamethasone, in pediatric patients, from 6 months to 17 years of age,…