NCT00834327

Efficacy and Safety Study of Aplindore in Patients With Restless Legs Syndrome

A Randomized, Double-Blind, Placebo-Controlled Four Week Study of the Efficacy and Safety of Four Doses (0.05 mg, 0.1 mg, 0.25 mg, 0.5 mg) of Aplindore MR Tablets vs. Placebo in Idiopathic Restless Legs Syndrome.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Neurogen Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Two hundred and thirty patients will be randomly assigned to one of five treatment arms in this outpatient study. Of the four aplindore arms, two arms will be titrated over a brief period until the targeted dose is achieved, and then as with the other arms, will be maintained for several weeks. Dosing will take place over a total of about 4 weeks.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	aplindore MR tablets or Placebo	aplindore MR tablets administered QD for about 4 weeks

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-11-01
• Completion: 2009-12-01
• First posted: 2009-02-03
• Last updated: 2009-10-14

Locations

24 sites across 1 country: United States