6 results
Primary objective:Part 1: To determine the safety, tolerability, and RP2D of a daily dosing schedule (induction) of GSK3745417 Part 2: To evaluate clinical efficacy following the daily dosing *induction* period of GSK3745417 in participants with…
Phase 2:• To assess the safety, tolerability, systemic exposure, and efficacy of AMT-101 in subjects with chronic antibiotic-resistant pouchitis• To select an AMT-101 dose for Phase 3Phase 3:Co-primary Objectives:• To determine the effect of AMT-101…
Primary Objective: To determine the effectiveness of methylphenidate in reduction of ADHD symptomatology, operationalized by personalized goals that are important to the patient and its environment, in individuals with late-diagnosed PKU. Secondary…
To evaluate the effects of AMT-101 in combination with adalimumab on UC disease activity as measured by symptoms, endoscopy, histology, and biomarkers. To evaluate the safety and tolerability of oral AMT-101 over 8 weeksTo assess the PK parameters…
The main objective of this study is to compare the acute effects of methylphenidate on behavioral and cognitive functioning in 6 to 12 year old treatment naïve children compared to the effects after nine months of treatment with methylphenidate in…
The primary objective is to determine the efficacy of methylphenidate on ADHD symptoms in Smith Magenis syndrome.The secondary objectives include the efficacy of methylphenidate on emotion dysregulation and specific goals that are important to the…