Efficacy and Safety Study of Aplindore in Patients With Restless Legs Syndrome
Status:
Terminated
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
This is a clinical trial to be conducted at multiple sites in the USA. Patients diagnosed
with moderate to severe Restless Legs Syndrome will be randomly allocated to one of 5
treatment arms in the study. The 5 arms include 4 arms with different doses of aplindore MR
tablets and 1 placebo arm. The treatment will be taken once a day. The study is blinded and
neither patients, nor the investigators, will know what treatment the patient is receiving.
Patients will be assigned a dose and will be maintained at that dose for several weeks (2
treatment arms include a short titration period). The entire study will take about 6 weeks.
The study will measure how effective aplindore is in decreasing symptoms of Restless Legs
Syndrome, and will also assess the safety and tolerability of aplindore.