Soleno Therapeutics, Inc. announced that it has initiated a randomized withdrawal period of Study C602, an ongoing open-label extension study of DCCR (Diazoxide Choline) Extended-Release tablets for the treatment of Prader-Willi syndrome (PWS). The randomized withdrawal period of Study C602 is a multi-center, randomized, double-blind, placebo-controlled study of DCCR in approximately 80 patients with PWS at 17 sites in the U.S. and 5 sites in the U.K. This randomized withdrawal period consists only of patients currently enrolled in Study C602 and will not enroll any new patients. Upon Institutional Review Board/Ethics approvals at their respective sites, patients who consent to participate in the randomized withdrawal period, will be randomized to receive DCCR or placebo for a period of four months.
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- Soleno Therapeutics, Inc. Therapeutics Announces Initiation of Randomized Withdrawal Study of DCCR for the Treatment of Prader-Willi Syndrome