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A Randomized, Two-Period, Double-Blind Placebo-Controlled and Open-Label, Multicenter Extension Study to Determine the Long-Term Safety and Tolerability of JNJ-54861911 in Subjects in the Early Alzheimer*s Disease Spectrum

The primary objective of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 in subjects in the early AD spectrum that have completed a Phase 1b or Phase 2 clinical trial with JNJ 54861911 (e.g., Study 54861911ALZ2002),…

An open-label, single arm, multi-centre, phase II study investigating safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of imlifidase (IdeS) in patients with Guillain-Barré Syndrome (GBS), in comparison with matched control patients

The objectives of this study are to:• Assess safety and tolerability of imlifidase in combination with standard IVIg treatment in GBS subjects• Evaluate pharmacokinetics of imlifidase• Evaluate pharmacodynamics profile of imlifidase• Evaluate…

A Phase IIb open-label, multi-centre, extension study to explore the long-term safety and efficacy of KH176 in subjects with a genetically confirmed mitochondrial DNA tRNALeu(UUR) m.3243A>G mutation who have completed the KHENERGYZE study KH176-202.

The primary objective of this study is to enable continued treatment with the study drug sonlicromanol for patients who have completed study KH176-202 and to investigate the safety and tolerability of sonlicromanol over an 12 months treatment period…

AN OPEN-LABEL, MULTI-CENTRE STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF REN001 IN SUBJECTS WITH PRIMARY MITOCHONDRIAL MYOPATHY (PMM)

Primary Objective:To evaluate long-term safety and tolerability of REN001 in subjects with PMM.Secondary Objective:To evaluate subjects with mtDNA-PMM who are receiving long-term treatment with REN001 in terms of PMM associated symptoms, exercise…

An open-label, multicenter, extension study to evaluate the safety and efficacy of padsevonil as adjunctive treatment of focal-onset seizures in adult subjects with drug resistant epilepsy

Objectives:Primary objectiveTo evaluate the long-term safety and tolerability of padsevonil (PSL) administered at individualized doses between 100 mg/day and 800 mg/day as adjunctive treatment for subjects with focal-onset seizures and drug-…

[18F]MC225-PET: Assessment of the blood-brain barrier integrity and P-glycoprotein function in healthy volunteers,a pilot study

Translation of [18F]-MC22518 to the clinic to measure P-gp function in healthy volunteers.