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A 2-Part Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-63733657 in Healthy Subjects and Subjects With Alzheimer*s Disease

This will be the first study with JNJ-63733657 in humans to investigate the safety, tolerability and pharmacokinetics of JNJ-63733657 and to explore potential pharmacodynamic (PD) effects in healthy subjects following single dose administration and…

A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of padsevonil as adjunctive treatment of focal-onset seizures in adult subjects with drug-resistant epilepsy

Objectives:Primary objective:To evaluate the efficacy of the 3 selected dose regimens of Padsevonil (PSL) administered concomitantly with up to 3 antiepileptic drugs (AEDs) compared with Placebo for treatment of observable focal-onset seizures in…

A two-part, single dose, randomized, single-blinded, placebo controlled, phase I study to assess the safety and pharmacokinetics of oral MT1980 in healthy volunteers when dosed in the fasted state

In this study we will investigate how safe the new compound MT1980 is and how well it is tolerated when it is used by healthy participants. We also investigate how quickly and to what extent MT1980 is absorbed, transported, and eliminated from the…

A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis

To demonstrate that ofatumumab is superior to teriflunomide in reducing the frequency of confirmed relapses as evaluated by the annualized relapse rate (ARR) in patients with relapsing MS

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…

Improving cognitive performance in MS by transcranial alternating current brain stimulation (tACS): a pilot study

Here we will test the hypothesis that tACS (theta-tACS at 6 Hz) will enhance brain synchrony in MS patients, thereby improving their cognitive functioning. We further want to achieve the increase in fronto-temporal brain synchronization measured by…

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…

A Randomized, Double-blind, Placebo-controlled, Parallel-group,
Multicenter Study to Assess the Efficacy and Safety of JNJ-63733657, an
Anti-tau Monoclonal Antibody, in Participants with Early Alzheimer's
Disease

This study has been transitioned to CTIS with ID 2022-501188-42-00 check the CTIS register for the current data. This Phase 2 study for JNJ-63733657 will assess the possible slowing of cognitive decline seen inprodromal AD and mild AD dementia (…

A DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 24 WEEKS TREATMENT WITH REN001 IN PATIENTS WITH PRIMARY MITOCHONDRIAL MYOPATHY (PMM)

Main Objective:To evaluate the efficacy of REN001 in subjects with PMM treated for 24 weeks, assessed by the effect on exercise endurance.Secondary Objective:To evaluate the efficacy of REN001 in subjects with PMM treated for 24 weeks, assessed by…

A randomized, double-blind, placebo-controlled study of the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of CFTX-1554 in healthy subjects, with comparison of intake of CFTX-1554 as liquid formulation and as capsule, and after a high-fat breakfast versus fasted.

In this study we will investigate how safe the new compound CFTX-1554 is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent CFTX-1554 is absorbed, distributed, metabolized, and…

Phase 1 open-label, crossover study to evaluate the effect of food on the pharmacokinetics and safety of a single oral dose of PTC518 in healthy volunteers.

In this study we will investigate what the effect of food is on how the study compound PTC518 is absorbed, transported, and eliminated from the body.We will also investigate how safe the new compound PTC518 is and how well it is tolerated when it is…

A randomised, double-blind, placebo-controlled crossover study to investigate the effect of buprenorphine on fentanyl induced effects on nociceptive thresholds and CNS functioning in opioid tolerant patients.

Primary objectives- To evaluate the effects of buprenorphine on fentanyl induced analgesia using the PainCart test battery in OT patients, when compared to placebo.Secondary objectives- To evaluate the effects of buprenorphine on fentanyl induced…

A Phase 1, Randomized, Open-Label, Crossover Study to Evaluate Relative Oral Bioavailability of 2 Formulations of PTC857 When Administered as a Single Dose to Healthy Subjects

In this research study we will compare a new PTC857 formulation to the current PTC857 formulation. The aim of the new formulation is to improve ease of manufacturing and to reduce the effect of food on PTC857 uptake. Our aim is to study how quickly…

A Non-Randomized, Open Label, Adaptive, Single Center, Positron Emission Tomography (PET) Study to Assess Distribution of RO7248824 in the Central Nervous System Following Single Intrathecal Doses of [89Zr]-Labeled RO7248824 in Healthy Male Participants

The new compound RO7248824 is being developed for the treatment of Angelman syndrome (AS). The purpose of this study is to find out how RO7248824 spreads in the brain and spine after injection into the spinal canal (intrathecal administration). This…

A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy Study To Evaluate Safety And Efficacy Of Ocrelizumab In comparison with Fingolimod in Children And Adolescents With Relapsing-Remitting Multiple Sclerosis

This study has been transitioned to CTIS with ID 2023-506516-40-00 check the CTIS register for the current data. The primary efficacy objective for this study is to demonstrate non-inferiority of ocrelizumab compared with fingolimod

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTINATIONAL, MULTICENTER STUDY WITH OPEN-LABEL TREATMENT EXTENSION TO ASSESS THE EFFECT OF MIN-102 ON THE PROGRESSION OF ADRENOMYELONEUROPATHY IN MALE PATIENTS WITH X-LINKED ADRENOLEUKODYSTROPHY

Main StudyPrimary efficacy objective: To evaluate the efficacy of MIN-102 on the progression ofadrenomyeloneuropathy (AMN) in male patients as determined by the change from baseline in Six-Minute Walk Test (6MWT) compared with placebo after 96 weeks…

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

This study has been transitioned to CTIS with ID 2023-507906-15-00 check the CTIS register for the current data. This study is designed to collect long-term safety, tolerability, effectiveness and health outcomes data in RMS patients.COVID-19…

A PHASE 1B, ADAPTIVE, MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL DESIGN STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO7486967 IN PARTICIPANTS WITH EARLY IDIOPATHIC PARKINSON*S DISEASE

The objective of the study is to assess the safety and tolerability, and to characterize the pharmacokinetics (PK) and pharmacodynamics (e.g., Cerebrospinal fluid [CSF] levels of IL-1β, TSPO positron emission tomography [PET] imaging) of selnoflast…

A Phase Ib/IIa Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Doses, Regimens and Combinations of Tau Targeted Vaccines in Subjects with Early Alzheimer*s Disease

The purpose of this research study is to evaluate the safety and tolerability of two study vaccines, ACI-35.030 and JACI-35.054 in subjects with a mild form of Alzheimer*s disease who are 50-75 years-old. Both study vaccines have been designed to…

A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib.

This study has been transitioned to CTIS with ID 2023-509345-12-00 check the CTIS register for the current data. The purpose of the study is to provide efficacy, safety and tolerability data for remibrutinib to support regulatory approval worldwide…