If you suffer from Restless Legs Syndrome, you may be eligible for a current trial that is recruiting a total of 230 patients from 15 states. Within these 15 states there will be a total of 24 trial sites studying the safety and efficacy of Aplindore, an experimental drug, to treat Restless Legs Syndrome. The 230 participants will be divided into a total of five groups: four groups receiving different doses of Aplindore and one group receiving the placebo.
Aplindore was studied in a previous phase II trial for RLS symptoms and the 0.5 mg starting dose achieved “statistically significant efficacy.” This indicates that the drug may be better tolerated than previously thought and that a slow phasing in process of treatment may not be necessary as it is for current drugs prescribed to treat RLS.
Partial inclusion criteria for this trial:
- Male & female RLS patients between the ages of 18 – 85.
- RLS symptoms must be moderate to severe.
- Sleep must be disrupted at least 3 nights a week for a minimum of 3 months.
- Patients must be off dopamine agonists or other meds taken for RLS for a specified period before Day 1 of the trial.
For full details on the inclusion & exclusion criteria for this trial, please visit the Clinical Trials.gov website: