Safety and Tolerability of the D1 Dopamine Receptor Antagonist Ecopipam in Patients With Lesch-Nyhan Disease
Completed
Psyadon Pharma
Phase 1
The purpose of this study is to determine the effects of ecopipam in patients with
Lesch-Nyhan Disease (LND). Ecopipam specifically blocks the actions of one chemical in the
brain that helps nerves talk to one another; ecopipam does this by stopping the chemical
(dopamine) from binding to one of its family of receptors (i.e, the D1 family). LND is a very
rare genetic disease. The sponsor is doing this study to find out what side effects ecopipam
causes in LND patients, and whether ecopipam may be able to relieve the self-injurious
behaviors seen in these patients.
Tourette's Syndrome is a neurological disease characterized by verbal and motor tics. The
currently available drug treatments are considered to be inadequate. This clinical trial is
designed to test if ecopipam is effective for the treatment of Tourette's Syndrome in adults.
Safety and Tolerability Comparison of Immediate and Controlled Release Formulations of Ecopipam
Completed
Psyadon Pharma
Phase 1
Ecopipam hydrochloride (HCl) is an investigational drug being studied for several possible
diseases. To date, all clinical studies have been done using the ecopipam immediate release
(IR) tablet. However, a controlled release (CR) capsule formulation of ecopipam has been
produced that may be able to improve its effectiveness and reduce its side effects. The main
purpose of this study is to evaluate the safety and tolerability of ecopipam CR capsules when
given as single oral dose in healthy volunteers.
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