N/A N=10 Treatment

The Effect of Horizant (Gabapentin Enacarbil) on Augmentation

Restless Legs Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02642315 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2022

Primary outcome: Primary: Change in Augmentation Severity From Day 0 to Day 90 — 6.5; 0 score on a scale — p=0.0131

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Horizant (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Missouri-Columbia
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Augmentation Severity From Day 0 to Day 90	6.5; 0	0.0131 sig
SECONDARY Change in Augmentation Severity Rating Scale Form Day 0 to Day 360 (270 Days After Discontinuation pf Dopaminergic Medication)	6.5; 0	0.0131 sig

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.

Eligibility Criteria

Inclusion Criteria

Adult patients with diagnosis of RLS for more than one year.
Patients who are on DA therapy for 6 months or longer.
Patients who developed Augmentation (on stable dose of DA) lasting for 3 months or longer.
Augmentation severity rating scale of 5 to 15.
Both males and females
Age range = 18-85 year

Exclusion Criteria

Known Hypersensitivity to Horizant or Gabapentin products
Peripheral neuropathy
Radiculopathy
Peripheral vascular disease
Uremia [abnormal blood urea nitrogen (BUN) or Creatinine on Comprehensive Metabolic Panel (CMP)]
Anemia
Patients who are currently pregnant
Patients who currently take opioids, lithium, anti-nausea medications (e.g. metoclopramide), dopaminergic antagonists (e.g. Haloperidol), 1st generation antihistamines (e.g. diphenhydramine, pseudoephedrine), anti-psychotic medications and iron therapy.
Subjects with impaired decision making capability.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02642315). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.