115 results
The primary objective of this study is to assess efficacy and safety of BI 409306 at doses of 10 mg, 25 mg and 50 mg once daily, 25 mg twice daily compared to placebo over a 12-week treatment period in patients with the following criteria: mild…
Primary:* Evaluate the safety and tolerability of ALKS 7119 following oral administration of multiple ascending doses of ALKS 7119 in healthy male and female adultsSecondary:* Evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ALKS 7119…
To evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ALKS 7119 following oral administration of single ascending doses of ALKS 7119 in healthy male adults
Determine efficiency and safety of two different doses of pregabalin as compared to placebo.
This study aims to demonstrate the clinical efficacy of patisiran and to establish the safety of chronic dosing in ATTR patients with FAP.The primary objective of the study is to determine the efficacy of patisiran by evaluating the difference…
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),…
To study sensory processing and hyperexcitability in children with ASD and epilepsy using neurophysiological measurements (EEG/ERP).
Various brain areas play a crucial role in both pain and cognition, supporting the existence of a close relationship between pain and cognition. Consequently, it is important to examine whether pain experience changes at the moment the patient shows…
This safety study in subjects in the early (predementia) AD spectrum is performed to investigate primarily the safety and tolerability of JNJ-54861911 during 6 months of treatment.
To provide further insight into Souvenaid*s hypothesised mode of action, the current NL-ENIGMA study explores brain glucose metabolism in mild cognitive impairment (MCI) and mild dementia due to AD, using Positron Emission Tomography with 18F-FDG-…
The aim of this study is to examine the daily level of activities and participation after LTH in children and adolescents (6-18 years) and to identify possible predictors. In addition, experimental research is done in a subgroup to measure the…
To establish the incidence and consequences (impairments op body functions, limitations in participation) of traumatic brain injury in children and youth in a region of The Netherlands as well as the incidence of the same symptoms in a group of…
The primary objective of the SafeBoosC trial is to examine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants (gestational age < 28 wks) during the first 72 hours of life through the application of cerebral…
The objective of the trial is to assess the safety and tolerability of i.c.v. administration of sNN0029 infusion solution at a dose of 4 µg per day delivered via a Medtronic SynchroMed® II Infusion System.
- Can early Botox-injections in the bladder of patients with meningomyelocèle (MMC) prevent deterioration of the bladder and renal function?- Can early Botox-injections in the bladder of patients with meningomyelocèle (MMC) decrease the need for an…
To explore the effects of the test product compared to the control product on brain phospholipid metabolism in mild AD patients using 31P-MRS. To explore the effects of the test product compared to the control product on the level of brain…
This proof-of-mechanism (POM) study in subjects with early AD, being subjects asymptomatic at risk for AD and subjects with pAD, is performed to confirm a drug interaction with the intended enzyme (BACE) at the intended target location (brain) by…
Primary ObjectivesTo evaluate the safety and efficacy of 2 fixed doses of EVP-6124 hydrochloride (HCl) ( 2 or 3 mg daily) compared to placebo for 26 weeks in subjects with mild to moderate dementia due to Alzheimer*s disease (AD) currently receiving…
Primary objectives:To determine the exposure-response relationship of EVP-6124 over a range of plasma concentrations in a scopolamine-induced cognitive deficit model in healthy elderly subjects.Secundary objectives:To determine the exposure-response…
Primary Efficacy Objective* The primary objective of this study is to evaluate the efficacy of two dose levels of pregabalin compared to placebo as an adjunctive treatment in reducing the frequency of partial onset seizures in pediatric subjects 1…