The Effects of Aplindore on the Treatment of Signs and Symptoms of Restless Legs Syndrome
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess the efficacy and tolerability of single doses of
aplindore compared to placebo in RLS. Patients will be required to spend 5-8 nights in a
sleep laboratory. This includes 1 adaptation night, 1 placebo night, and 3-6 drug treatment
nights. Ascending doses of active drug will be administered on study nights 3 through 5 to
determine the maximum well tolerated efficacious dose (defined as a decrease in Periodic Limb
Movement Index (PLMI) of at least 50% from placebo baseline). If an efficacious dose cannot
be identified the Investigator in consultation with the sponsor may decide to examine higher
doses in up to 3 additional PSG nights in an attempt to identify a tolerable efficacious
dose. This study will utilize up to 24 evaluable patients, each meeting International
Classification of Sleep Disorders (ICSD-2) diagnostic criteria for primary RLS who are not
currently taking any RLS medication including DAs ( and L-dopa) or who are able to
discontinue their RLS medication at least 5 half-lives prior to the adaptation night.