7 results
The primary objective of this study is to provide access to SPD503 following participation in SPD503-315 or SPD503-316. The primary outcome of this study is to evaluate the long-term safety of SPD503. The evaluation of safety will be based on the…
The primary objective of this study is to evaluate the long-term maintenance of efficacy of SPD503 in childrenand adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label,short-term treatment…
Objectives: The following trial objectives for adult patients with plasma therapy-resistantAtypical Hemolytic-Uremic Syndrome (aHUS) are to:Primary:• Assess the effect of eculizumab to reduce thrombotic microangiopathy (TMA) asindicated by…
Objectives: The following trial objectives for adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS) are to:Primary:* Assess the effect of eculizumab on TMA-Event Free status defined as the absence of [1] decrease in…
Objectives: The following trial objectives for adolescent patients (from 12 and up to 18 years of age) with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS) are to:Primary:* Assess the effect of eculizumab on TMA-Event Free status…
Objectives: The following trial objectives for adult patients with plasma therapy-resistantAtypical Hemolytic-Uremic Syndrome (aHUS) are to:Primary:• Assess the effect of eculizumab to reduce thrombotic microangiopathy (TMA) asindicated by…
Primary objectives:Cohorts 1 and 2Maintenance Arm(s) Combinations:-To assess efficacy of combination therapy with ONC201 and novel agent in participants with DMG based on median progression-free survival at 6 months (PFS6) Cohort 3-To assess…