17 results
The primary objective is to assess the proportion of patients in each treatment arm with a satisfactory clinical response as defined by a composite primary endpoint at Week 24.The secondary objective is to demonstrate safety and clinical effect at…
The aim of this research project is to investigate cannabidiol as a new medicine to target the cannabinoid system in the reduction of anxiety disorder symptoms. The research question is whether cannabidiol, as an augmentation strategy of exposure…
Primary Objective: To determine whether GWP42003-P affects the pharmacokinetic (PK) profile of stiripentol (STP) or valproate (VPA).Secondary Objective: To assess the safety and tolerability of GWP42003-P in the presence of STP or VPA.To assess…
To assess the efficacy of GWP42003-P as an adjunctive antiepileptic treatment compared with placebo, with respect to the percentage change from baseline during the treatment period of the study in convulsive seizure frequency. The dose response…
The purpose of the study is to investigate to what extent CBD is safe and tolerated. It will also be investigated how quickly and to what extent CBD is absorbed and eliminated from the body (this is called pharmacokinetics). Furthermore the effect…
The properties of CBD, namely potential effects on variables pertaining to fear extinction and potentially on fear retention/reinstatement while having non of the problematic side-effects found in Δ9-THC, make CBD plausibly preferential over Δ9-THC…
Primary objective: To evaluate the efficacy of GWP42003-P as adjunctive treatment inreducing the number of drop seizures when compared with placebo, inpatients with LGS.Drop seizure is defined as an attack or spell (atonic, tonic or tonic-clonic)…
Primary objectiveTo investigate wether Sildenafil treatment results in a reduction of pulmonary artery pressure without decrease of cardiac output in HFpEF patients with PHSecondary objectivesTo investigate wether Sildenafil treatment results in a…
This study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone treatment (study treatments) in patients with advanced idiopathic pulmonary fibrosis (IPF) and intermediate or high probability of Group 3…
Primary Objective Blinded Phase:• To evaluate the efficacy of GWP42003-P as add-on therapy in reducing the frequency of seizures when compared with placebo in patients with TSC.Open-label Extension:• To evaluate via the adverse events (AE) profile…
The primary objective of this study is to compare microglia activation as measured with proton Magnetic Resonance Spectroscopy (1H-MRS) between recent-onset schizophrenia patients who are randomised to CBD and those randomised to placebo. Secondary…
PrimaryTo demonstrate the non-inferior antiviral activity of switching to DTG +3TC once daily compared to continuation of TBR over 48 weeks in HIV-1 infected, ART therapy (ART)-experienced, virologically suppressed subjectsSecondary- To demonstrate…
The properties of CBD, namely potential effects on variables pertaining to fear extinction and potentially on fear retention/reinstatement while having non of the problematic side-effects found in *9-THC, make CBD plausibly preferential over *9-THC…
We aim to compare the effectiveness of sildenafil versus placebo in achieving healthy perinatal survival, in women with singleton pregnancies with severe fetal growth restriction of placental origin.
The aim of this project is to investigate CBD as a new medicine to target the ECS in the reduction of anxiety symptoms. Subsidiary aims of the project are to investigate the effects of CBD on fear extinction and extinction consolidation, stress…
To determine the most effective drug (iNO or IV sildenafil) for the treatment of PH in newborns with CDH and to reach evidence based dosing of this drug. Subsequently this drug will be added to the international guidelines for the treatment of…
Primary- To demonstrate non-inferior antiviral activity of DTG + 3TC versus DTG + TDF/FTC at 48 weeks in HIV-1-infected, ART-naïve subjectsSecondary- To demonstrate the antiviral activity of DTG + 3TC versus DTG + TDF/FTC at 24, 96 and 144 weeks- To…