Clinical Trial: EASE (Efficacy of ATX01 Study in Erythromelalgia)
Study Status: Completed
Recruit Status: RECRUITING
Condition: Erythromelalgia
Study Type: INTERVENTIONAL
Official Title: A Randomized, Double-blind, Placebo-controlled, 2-period, Crossover Study to Evaluate the Efficacy and Safety of ATX01 (Topical Amitriptyline Hydrochloride 15% w/w) in Adult Patients With Pain Du
Brief Summary:
The goal of this two-center, randomized, double-blinded, parallel-group, placebo-controlled clinical study is designed to compare the efficacy of twice daily applications of ATX01 versus placebo during two consecutive 3-week treatment periods.The primary objective is the comparison between Treatments (ATX01 15% vs. Placebo) of mean pain attack intensity score assessed for the final week of each treatment period using an 11-point Numerical Pain Rating Scale (NPRS).Mean pain attack intensity is defined as the sum of…
Read more