The Effect of Horizant (Gabapentin Enacarbil) on Augmentation

NACompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

May 6, 2019

Study Completion Date

May 6, 2019

Conditions
Restless Legs Syndrome
Interventions
DRUG

Horizant

"Phase1: During phase 1 therapy, Horizant will be added on as an adjunct to all subjects taking part in the study along with stable dose of their current dopaminergic (DA) agent and both medication will be continued for a total period of 90 days from day 0 to day 90. Subjects will be evaluated for three visits (days 0, 30 and 90) during Phase I.~Phase 2: At the 90th day follow-up visit, with initiation of phase 2 therapy, all subjects will be tapered off (by 50% reduction in dose each week) of their current dopaminergic agents while maintaining the same dose of Horizant and will be on Horizant monotherapy. All subjects will be evaluated for additional three clinic visits (days 120, 180, 360)."

Trial Locations (1)

65212

University of Missouri Health Care, Columbia

All Listed Sponsors
lead

University of Missouri-Columbia

OTHER

NCT02642315 - The Effect of Horizant (Gabapentin Enacarbil) on Augmentation | Biotech Hunter | Biotech Hunter