The Effect of Horizant (Gabapentin Enacarbil) on Augmentation

NCT02642315 | Completed Results

• 1 other identifier: 2002392
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Augmentation Severity From Day 0 to Day 90

  Augmentation severity rating scale; 0-24, 0 is better, 24 is worst

  From Day 0 (Baseline) to Day 90

Secondary Outcomes (1)

• Change in Augmentation Severity Rating Scale Form Day 0 to Day 360 (270 Days After Discontinuation pf Dopaminergic Medication)

  Day 0 to day 360 (270 days after discontinuing dopaminergic medication)

Study Arms (1)

open-label

OTHER

open-label single arm study Horizant, 600 mg oral once daily at 5 pm for 360 days.

Drug: Horizant

Interventions

Horizant DRUG

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).

Also known as: Gabapentin enacarbil

open-label

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Gabapentin; 1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Limited (small numbers) open label study

Results Point of Contact

• Title: Pradeep Sahota MD
• Organization: University of Missouri Columbia

sahotap@missouri.edu

573-882-6402

Study Officials

• Pradeep Sahota, MD

  University of Missouri Health Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chairman, Dept. of Neurology

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: December 30, 2015
• Study Start: January 1, 2016
• Primary Completion: May 6, 2019
• Study Completion: May 6, 2019
• Last Updated: February 24, 2022
• Results First Posted: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)