6 results
OBJECTIVESPrimary ObjectiveThe primary objective is to evaluate the efficacy, safety, and tolerability of 800 and 1,200 mg/day of carisbamate compared with placebo in reducing the average daily pain in subjects with diabetic peripheral neuropathy (…
Double-Blind Study CARISEPY3013:The primary objectives of this study are to compare the efficacy safety, and tolerability of carisbamate as adjunctive treatment of partial onset seizures, relative to placebo. The secondary objectives of this study…
Primary ObjectivesParts 1 (Subjects with F/MF genotypes) and 2 (Optional; Subjects with the F/F genotype)* To evaluate the safety and tolerability of VX 121 in TC with TEZ/VX 561 (deuterated IVA) * To evaluate the efficacy of VX 121 in TC with TEZ/…
Main objective:Part ATo evaluate the long-term safety and tolerability of VX-661 in combination with ivacaftor in subjects with CF, homozygous or heterozygous for the F508del-CFTR mutation who are in the Treatment Cohort.Part B and Part CNot…
The purpose of the study is to investigate how quickly and to what extent radiprodil is absorbed and eliminated from the body (this is called pharmacokinetics). It will also be investigated to what extent radiprodil is tolerated. In addition, 2 new…
Primary Objective:-To determine the long-term safety and tolerability of multiple individually titrated doses of radiprodil as an addon therapy to standard of care (SOC)in pediatric participants-To establish a safe and well tolerated dose after 8…