3 results
Primary• To assess the efficacy of a fixed dose of pregabalin to placebo during the first12-week treatment period in subjects with RLS.• To compare the rate of augmentation of a fixed dose of pregabalin to 2 fixed doses ofpramipexole over 9 or 12…
The primary endpoint is overall survival (OS) in patients with low hENT1 expression. Ifthe hENT1 expression data are available for analysis prior to randomizing 250 patientsthen an interim analysis for sample size re-estimation may be performed.
To provide subjects who have completed participation in a Phase 2 or Phase 3 trial continued access to therapy and to evaluate the long-term safety and tolerability of leuco-methylthioninium bis(hydromethanesulfonate) given in flexible doses of up…