Long-Term Study of Gabapentin Enacarbil (GEn, XP13512) vs. Placebo in Patients With Restless Legs Syndrome.

Summary

The primary objective of this trial is to assess the maintenance of efficacy of gabapentin enacarbil (GEn, XP13512) taken once daily in the long-term treatment of patients suffering from Restless Legs Syndrome (RLS).

Timeline

Start

2006-04

Primary completion

2007-11

Completion

2007-11

Outcome

Met primary endpoint

registry DB Placebo vs DB GEn 1200 mg; p = 0.0158; Odds Ratio (OR) 0.353 (95% CI 0.2 to 0.8) NCT00311363 ↗

Publications

• Background Bogan RK, Bornemann MA, Kushida CA, Tran PV, Barrett RW; XP060 Study Group. Long-term maintenance treatment of restless legs syndrome with gabapentin enacarbil: a randomized controlled study. Mayo Clin Proc. 2010 Jun;85(6):512-21. doi: 10.4065/mcp.2009.0700.

Drugs

Indications