24 trial sites in 15 states are recruiting a total of 230 patients with moderate to severe restless legs syndrome for a six-week trial of the controlled release drug aplindore MS.
The trial targets 230 patients, who will be randomly assigned to five groups – four groups taking different dosages of the drug and one group taking a placebo (fake dose).
In a previous phase 2 trial for RLS symptoms, a 0.05 mg “starting dose” of aplindore reportedly achieved “statistically significant efficacy,” possibly indicating the drug may be better tolerated and not require the slow phasing in or titration needed with drugs now prescribed for RLS. As a “dopamine partial agonist,” aplindore activates dopamine receptors, but to a lesser extent than a full dopamine agonist. (The neurotransmitter dopamine has been shown to reduce RLS symptoms. It is responsible for arousal or alertness, by comparison with serotonin, which relaxes.)
• Patients ages 18-85 of both sexes may be eligible for the trial.
• Symptoms must be moderate to severe, disrupting sleep for at least 3 nights per week for a least 3 months,
• And the person must be off dopamine agonists or other meds taken for RLS for a specified period before Day 1 of the trial.
For more information about the trial and locations of the trial sites, and to contact the trial organizers, visit the ClinicalTrials.gov site for Efficacy and safety Study of Aplindore in Patients with Restless Legs Syndrome, Identifier NCT00834327