NCT02117076

Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizant™) in Restless Leg Syndrome

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Theresa Zesiewicz, MD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin) versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome.

Detailed description

The study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin) versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome. Subjects will be randomized to gabapentin (IR) or Horizant™ (ER). Dosing will be blinded to both patient and study team members. Once study medication dosing has been optimized, subjects will then remain on a stable dose for six weeks until study endpoint, after which subjects will be down-titrated off of study medications.

Conditions

• Restless Leg Syndrome

Interventions

Type	Name	Description
DRUG	Gabapentin immediate release	up to 1200 mg per day
DRUG	Gabapentin enacarbil extended release	up to 1200 mg per day

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2014-04-17
• Last updated: 2021-11-16

Locations

1 site across 1 country: United States