Chelsea Therapeutics has enrolled 118 randomised patients for Study 301, the second of two pivotal Phase III clinical trials in Chelsea’s registration program of Droxidopa for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH).
The company said, the Droxidopa Phase III registration program in NOH includes two, double-blind, placebo-controlled studies: Study 301 and Study 302. Both studies compare Droxidopa to placebo for the treatment of symptomatic NOH and are designed to demonstrate a mean improvement over placebo of 1.6 units on the Orthostatic Hypotension Symptom Assessment (OHSA) scale.
Dr Simon Pedder, president and CEO of Chelsea, said: “With top-line data from Study 302 expected within weeks, reaching our target enrollment in Study 301 marks a significant turning point in our Droxidopa development program as we conclude our clinical efficacy evaluations and move ahead with our regulatory submission and commercialisation efforts. Top-line data from Study 301 is expected late next quarter and we anticipate initiating a rolling NDA submission in the same quarter.”