NCT01386944 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Trenkwalder C, Canelo M, Lang M, Schroeder H, Kelling D, Berkels R, Schollmayer E, Heidbrede T, Benes H
Management of augmentation of restless legs syndrome with rotigotine: a 1-year observational study. Sleep Med. 2017 Feb;30:257-265. doi: 10.1016/j.sle

Non Interventional Observational Study to Collect Data for the Effect of Switching to Neupro® on Severity of Restless Leg Syndrome (RLS) Symptoms and Augmentation as Well as the Change in Treatment Regimen Used, in RLS Patients With Previous Augmentation

Details for clinical trial NCT01386944

Clinical trial NCT01386944 - References