20 results
Primary: To evaluate the efficacy of retigabine as adjunctive therapy to each of the following specified monotherapy AED treatments: carbamazepine/ oxcarbazepine, lamotrigine, levetiracetam or valproic acid in subjects with partial-onset seizures (…
To compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight plus budesonide (9mg/d) vs. ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. To study safety and…
Primary: Long-term safety and tolerability.Secondary: Long-term efficacy.
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…
* To demonstrate efficacy of budesonide (9 mg budesonide/d) vs. placebo for induction of remission in active incomplete microscopic colitis after 8 weeks of treatment* To study the maintenance of remission after end of treatment* To study safety and…
To evaluate the efficacy of 9mg budesonide/day and 3g mesalazine/day compared to placebo for the induction of remission in lymphocitic colitis.
RationaleSince gamma band activity is thought to be an important mechanism in perceptual binding and cognitive function, interest in changes in gamma band activity in neuropsychiatric disorders has grown rapidly. Changes in gamma band oscillations…
To determine the efficacy and safety of memantine for patients with OCD.
The primary objective of this study is to evaluate whether adding intensive local anti-inflammatory therapy (Triamcinolone injection therapy combined with 9 mg oral BudenoFalk once daily for 24 weeks) to routine enteric balloon dilatation reduces…
Objectives:The objective of the trial is to evaluate efficacy and safety of two different doses of Nefecon® in the treatment of patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease, under rigorous blood pressure…
Purpose of the study is to find out if memantine in humans also has benificial effects on memory when given in combination with ecstacy. Therefore, ecstacy will be given in combination with memantine. A secondary goal is to find out the effects of…
The Primary objective is: 1) To investigate clinical effectiveness of the glutamatergic compound memantine in paediatric patients with: - Obessive-Compulsive Disorder (OCD) GOAT-1 - Autism Spectrum Disorder (ASD) GOAT-2 with respect to symptoms of…
Primary:* To assess the efficacy of 2 x 1 mg/d budesonide effervescent tablets vs. placebo for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis (EoE).Secondary:* To study safety and tolerability…
Primary objective: To study the effects of budesonide on the incidence of cabazitaxel induced diarrhea Secondary objectives: To study the effects of budesonide on other side effects of cabazitaxel (e.g. myelotoxicity), To study the pharmacogenetics…
Primary objective- Survival without BPD at 36 weeks gestational age (GA)Secondary objectives- Neurodevelopment at a corrected age of 18-22 months- Adverse treatment effects- Mortality at 36 weeks gestational age- BPD incidence at 36 weeks…
To study the effect size of FMT after a 3 weeks course of budesonide as induction therapy in patients with active ulcerative colitis despite previous therapy. The purpose of the pre-treatment is to reduce active inflammation prior to donor feces…
The Budesonide oral suspension is a new drug formulation especially developed for the treatment of eosinophile esophagitis in children and adolescents. The purpose of this clinical study is to investigate whether Budesonide oral suspension is…
Primary:* To assess the efficacy of a 48-week treatment with 2 x 0.5 mg/d or 2 x 1 mg/d budesonide effervescent tablets vs. placebo for the maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis (EoE).Secondary…
The objective of the study is to investigate whether the use of budesonde orodispergible tablets after ESD can prevent the devolpment of oesophageal strictures
Primary Objective To demonstrate that ICS can be safely withdrawn in T2-low asthma patients with obesity in secondary care (i.e. without loss of asthma control).Secondary Objectives1. To determine predictive factors for successful ICS withdrawal.2.…