5 results
Main Objective:To demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in (at least) 1 of the following populations with migraine: the overall pediatric population (6 to 17 year-olds) or the adolescent population…
The main objectives of the trial are to:• evaluate the safety of venetoclax monotherapy.• determine dose limiting toxicities (DLT) and the recommended Phase 2 dose (RPTD) of venetoclax monotherapy.• assess the pharmacokinetics (PK) of venetoclax…
The primary objective is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) and T-cell ALL as measured by the complete response (CR) rate.The secondary…
Primary Objectives Efficacy: To demonstrate the superiority of InO monotherapy vs ALLR3 induction in paediatric participants between 1 and < 18 years with HR first bone marrow relapse CD22-positive BCP ALL Secondary Objectives:Key Secondary…
This IDE trial is proposed herein to gather clinical data on the safety and effectiveness of a hybridsinus node sparing ablation procedure utilizing the AtriCure ISOLATOR Synergy Surgical AblationSystem to obtain an IST indication.