MedTrace Logo

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

NCT02117076 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-11-16

No results posted yet for this study

Summary

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

Conditions

  • Restless Leg Syndrome

Interventions

DRUG

Gabapentin immediate release

up to 1200 mg per day

DRUG

Gabapentin enacarbil extended release

up to 1200 mg per day

Sponsors & Collaborators

  • Theresa Zesiewicz, MD

    lead OTHER

Principal Investigators

  • Theresa Zesiewicz, MD, FAAN · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02117076 on ClinicalTrials.gov