Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome

PHASE2CompletedINTERVENTIONAL
Enrollment

217

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

January 31, 2008

Study Completion Date

January 31, 2008

Conditions
Restless Legs Syndrome
Interventions
DRUG

GEn (XP13512/GSK1838262)

Double-Blind Treatment Phase: 600 mg GEn (XP13512) orally, once daily for 3 days followed by 600 or 1200 mg on days 4-6, followed by 600 or 1200 or 1800 mg on days 7-9, followed by 600 or 1200 or 1800 or 2400 mg on days 10-84. Double-Blind Taper Phase: 600 or 1200 or 1800 mg GEn (XP13512) orally, once daily on days 85-86, followed by 600 mg or 1200 mg on days 87-88, followed by 600 mg on days 89-91

DRUG

Placebo

Placebo orally once daily

Trial Locations (1)

75213

GSK Investigational Site, Dallas

All Listed Sponsors
lead

XenoPort, Inc.

INDUSTRY

NCT01332305 - Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome | Biotech Hunter | Biotech Hunter