7 results
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…
Primary: • To evaluate the safety and effect on cholestasis of two seladelpar regimens (5 mg/day titrated to 10 mg/day and 10 mg/day) over 52 weeks of treatment compared to placeboKey Secondary: • To evaluate the effect of seladelpar on…
The purpose of this study is to compare the efficacy and the safety of an experimental drug, masitinib,in combination with riluzole to placebo in combination with riluzole administered during 48 weeks to patients suffering from ALS.You will be…
The objective is to evaluate the efficacy and safety of two doses of masitinib (4.5 mg/kg/day and 6.0 mg/kg/day) versus matching placebo in patients diagnosed with ALS treated with Riluzole (50 mg bid).The primary objective is to demonstrate…
Primary Objective: • Efficacy: To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on alkalinephosphatase (ALP) and total bilirubin at 12 months of treatment compared to placebo• Safety:…
Primary:• To evaluate the long-term safety and tolerability of seladelparSecondary:• To evaluate the long-term efficacy of seladelpar• To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)Exploratory• To evaluate the effect of…
The objective of this study is to examine the effect of riluzole on the glutamate/GABA balance in the brain in patients with 22q11.2DS. The secondary objective is to examine the effects of riluzole on psychotic symptoms and cognitive functioning. In…