6 results
The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…
The overall objectives of the iSPOT-D trial are to use standardised genetic-brain-cognitionprotocols to:1. Identify markers of MDD as a diagnostic group and its subtypes2. Identify markers which change with acute (8 weeks) drug treatment in MDD3.…
We propose to conduct a study in healthy subjects where a serotonergic challenge is given in a placebo-controlled, crossover fashion. Before each challenge, participants will be measured 1 time to define their baseline resting state networks (RSNs)…
To examine in depressed patients who reach a stable depression remission during optimal AD treatment: 1) whether discontinuation is possible; 2) when discontinuation is possible; and 3) in whom discontinuation is possible.
The objective of this pivotal study is to assess the long-term safety, tolerability, pharmacokinetics and pharmacodynamics of RP103 in pediatric and adult patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support…
To conform the procedural safety of the OSSURE LOEP Kit in the specific clinical setting of use in the femoral neck in patients with osteoporosis. Secondary objective: To evaluate the post-market clinical performance of the OSSURE LOEP Kit.