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An outpatient phase 3 efficacy study of Ecopipam (PSYRX 101) in the symptomatic treatment of self-injurious behavior in subjects with Lesch-Nyhan disease.

The primary objective of this study is to assess the efficacy of Ecopipam to reduce self-injurious behaviors (SIB) in adults and children with Lesch-Nyhan Disease (LND) in an outpatient setting. The secondary objectives of this study are to assess…

Memantine Add-On Therapy to Clozapine

This proposal entails a proof-of-concept study into the neuropsychological effects of memantine augmentation in a random cross-over comparison to placebo, as add-on treatment to ongoing clozapine in severely mentally ill (SMI) patients with…

A randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subject with Cystic Fibrosis aged six to seventeen years.

The purpose of this trial is primarily to assess the efficacy of inhaled mannitol compared with a true placebo in subjects with cystic fibrosis aged 6 to 17 years.We hypothesize that inhaled mannitol will improve the overall health and hygiene of…

Transcranial Direct Current Stmulation in Children with Unilateral Motor Deficits: A New Approach for Pediatric Rehabilitation.

The main objective of this study is to investigate the effect of a single tDCS session in children with mild CP on different motor tasks. The second objective is to identify the optimal site of stimulation. In tDCS research the electrodes can be…

A phase 1, double blind (3rd party open), randomized, placebo controlled, crossover single dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06372865 in healthy subjects

The objective of the first two cohorts of this study is to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06372865 after a single dose across a wide exposure range up to the maximum tolerated dose or the maximum…

A double-blind, placebo controlled, randomised, parallel group study with an open-label cross-over part, investigating safety, tolerability, pharmacokinetics, and pharmacodynamics after single ascending oral doses and a single intravenous dose of the vasopressin V2-receptor agonist FE 201836

The purpose of the study is to investigate to what extent FE 201836 is tolerated. It will also be investigated how quickly and to what extent FE 201836 is absorbed and eliminated from the body (this is called pharmacokinetics). Also the effect on…

Beneficial effects of the amino-acid food supplement L-Citrulline in Participants with Peripheral artery disease

Some studies have reported improved vascular function with the supplementation of L-arginine in participants with CVD. Several clinical studies have also begun the investigation of L-arginine supplementation in participants with PAD. This is…

A randomized, double blind, double-dummy placebo controlled, 3-way cross-over study to determine the test-retest reliability of, and the effect of oral retigabine and riluzole on, peripheral motor nerve excitability measurements in patients with ALS.

Patients with ALS are routinely prescribed riluzole, the only registered drug for the treatment of ALS. This study will evaluate the concentration-effect relationship of riluzole (100 mg) and retigabine (300 mg) on axonal excitability measures. In…

Father Trials: Hormonal Experiments on Prenatal and Postnatal Parenting

In a series of randomized control trials (RCTs) the following hypothesis will be tested: Intranasal administration of oxytocin and vasopressin affect neural and behavioral responses to infant signals and threat to the infant.* Oxytocin and…

The effect of an encapsulated nutrient mixture on ileal brake activation: A double-blind randomized study to investigate the effects on body weight, food intake and satiety

First part of study (Phase 1)Aim: To evaluate the efficacy of ileal brake activation, by ingestion of an encapsulated nutrient mixture delivered to the stomach (placebo) or distal small intestine (active) analysed by the amount of food consumed…

Randomized, double-blind, placebo-controlled oxytocin trial in children with Prader-Willi syndrome.
Effects on social behaviour.

To evaluate the effects of intranasal oxytocin versus placebo on social behaviour and also on eating behaviour in children with PWS.

A randomized, placebo and active comparator (oxycodone)-controlled study on the effect of tapentadol on respiration and analgesia in healthy volunteers

The objective of this study is to investigate the extent of respiratory depression at equi-analgesic dosages of tapentadol and oxycodone

Double blind, randomized, 2-way cross-over, placebo controlled study to evaluate the therapeutic and preventive effect of GLPG1205 on nociceptive and inflammation/sensitization induced pain in the UVB sunburn model in healthy male subjects

PrimaryTo assess the preventative effect of GLPG1205 on nociceptive and inflammation/sensitization induced pain in the UVB sunburn model using HPTol upon multiple dosing of GLPG1205 versus placebo.SecondaryTo further assess the preventative effect…

Acute effects of 40 mg cortisol on emotion and cognition.

To investigate acute effects of a single 40 mg dose hydrocortisone, compared with placebo, on stress and various aspects of attention and other cognitive processing of emotionally relevant stimuli in healthy anxious young females. The main question…

A randomized, double-blind, placebo controlled, crossover study to determine the effect of 5g egg protein hydrolysate (NWT-03) on arterial stiffness, microcirculation and blood pressure in otherwise healthy subjects with Metabolic Syndrome

To assess the acute (2h) and short term (2 days and 4 week) effects of daily administration of 5g of NWT03 (an egg-protein hydrolysate) on carotid-radial Pulse Wave Velocity (cr-PWV). Secondary objectives are to assess its effects on carotid-femoral…

A randomized, double blind, cross-over trial to study the effects of adding bezafibrate to standard lipid lowering therapy on postprandial lipids in patients with Familial Dysbetalipoproteinemia

To evaluate the difference in the post fat load non HDL after an oral fatload between bezafibrate and placebo in patients with FD using standard lipid-lowering therapy

Intra-subject variability in pain scoring and the consequences for analgesia treatment

In the current study we want to further explore the predictability of pre-treatment pain variability on the probability to experience pain relief. Knowledge on the understanding of individual differences in analgesic properties of a drug is of…

The effects of dietary nitrate supplementation on metabolic efficiency in patients with COPD

To assess whether ingestion of dietary nitrate in the form of NaNO3 solution is able to improve metabolic efficiency and exercise training compared to a NaCl solution placebo. A secondary objective will be to gain more insight in potential…

A randomized, double-blind, repeat dose cross-over study
to assess the bronchodilator effects of once daily QVM149
following morning or evening dosing for 14 days compared
to placebo in patients with asthma

To investigate the potential influence of time of dosing (morning or evening)on the bronchodilator effect of once daily orally inhaled QVM149 compared toplacebo.

Bilateral vs. unilateral transcranial magnetic stimulation of the primary motor cortex to treat chronic orofacial pain: a pilot study with a randomized controlled design

In 2016, Henssen et al. discuss that orofacial pain may be conducted in a bilateral fashion, inducing activation of both thalami [1]. For this reason, bilateral stimulation of the motor cortex is thought to induce a stronger analgesic effect…