Azurity Pharmaceuticals: Restless Legs Syndrome trials

The registry lists 13 Restless Legs Syndrome studies with Azurity Pharmaceuticals as lead sponsor. 0 are open to participants now and 7 have results posted.

Phase 1 4Phase 2 2Phase 3 5Phase 4 2(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment StudyCompletedNCT01668667Phase 4Results posted
• Simulated Driving Study in Restless Legs SyndromeCompletedNCT01332318Phase 2Results posted
• Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs SyndromeCompletedNCT01332305Phase 2Results posted
• Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep DisturbanceCompletedNCT00748098Phase 3Results posted
• XP13512 vs. Placebo in Patients With Restless Legs Syndrome.CompletedNCT00365352Phase 3Results posted
• XP13512 (Gabapentin Enacarbil) Extension Study in Patients With Restless Legs Syndrome.CompletedNCT00333359Phase 3Results posted
• Long-Term Study of Gabapentin Enacarbil (GEn, XP13512) vs. Placebo in Patients With Restless Legs Syndrome.CompletedNCT00311363Phase 3Results posted
• An Extension Study to Evaluate the Efficacy and Safety of HORIZANT in Adolescents With Moderate-to-Severe Primary RLSStatus unknownNCT02633683Phase 4
• A PK and Safety Evaluation of HORIZANT (Gabapentin Enacarbil) in Adolescents With Moderate-to-Severe Primary RLSWithdrawnNCT02633657Phase 1
• A Study to Evaluate the Effect of Gabapentin on Cardiac Repolarization in Healthy VolunteersCompletedNCT01516372Phase 1
• Drug Drug Interaction Study With Gabapentin Enacarbil and MorphineCompletedNCT01476124Phase 1
• Study to Assess the Effect of Gabapentin Enacarbil on Simulated Driving in Healthy SubjectsCompletedNCT01411124Phase 1
• XP13512 (GSK1838262) Versus Placebo in Patients With Restless Legs Syndrome.CompletedNCT00298623Phase 3