NCT02424695 - 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)

Alessandria M, Provini F
Periodic Limb Movements during Sleep: A New Sleep-Related Cardiovascular Risk Factor? Front Neurol. 2013 Aug 12;4:116. doi: 10.3389/fneur.2013.00116. eCollection 2013.
Earley CJ, Silber MH
Restless legs syndrome: understanding its consequences and the need for better treatment. Sleep Med. 2010 Oct;11(9):807-15. doi: 10.1016/j.sleep.2010.07.007. Review.
Sforza E, Jouny C, Ibanez V
Time course of arousal response during periodic leg movements in patients with periodic leg movements and restless legs syndrome. Clin Neurophysiol. 2003 Jun;114(6):1116-24.
Walters AS, Rye DB
Review of the relationship of restless legs syndrome and periodic limb movements in sleep to hypertension, heart disease, and stroke. Sleep. 2009 May;32(5):589-97. Review.
Winkelman JW, Shahar E, Sharief I, Gottlieb DJ
Association of restless legs syndrome and cardiovascular disease in the Sleep Heart Health Study. Neurology. 2008 Jan 1;70(1):35-42. doi: 10.1212/01.wnl.0000287072.93277.c9.

Effects of Gabapentin Enacarbil on Intensity of Cortical Arousal, Heart Rate, Blood Pressure and Anterior Tibialis EMG Responses Associated With PLMs During Sleep in Patients With RLS Using a Novel Computer Assisted Scoring System

Details for clinical trial NCT02424695

Clinical trial NCT02424695 - References