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The Effect of Horizant (Gabapentin Enacarbil) on Augmentation

NCT02642315 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-02-24

Study results available
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Summary

Restless Legs Syndrome (RLS) is a common neurological disorder. Augmentation is the main complication during long-term DA treatment of RLS. This study aims to examine effect of Horizant (Gabapentin Enacarbil) on Augmentation in RLS patients.

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).

Sponsors & Collaborators

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Pradeep Sahota, MD · University of Missouri Health Care

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2019-05-06
Completion
2019-05-06

Countries

  • United States

Study Locations

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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 NCT02642315 on ClinicalTrials.gov