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The Effect of Horizant (Gabapentin Enacarbil) on Augmentation (XP-IIT-0034)

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ClinicalTrials.gov Identifier: NCT02642315
Recruitment Status : Completed
First Posted : December 30, 2015
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Pradeep Sahota, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: Horizant Not Applicable

Detailed Description:

This is an Open label single arm study. The purpose of the study is to demonstrate the efficacy of Horizant in patients with RLS who exhibit augmentation while on Dopaminergic therapy. Adult patients (age 18-85 years) with diagnosis of primary RLS (diagnosed by study investigators) with augmentation on dopaminergic therapy will be screened for participation in the study. RLS diagnosis will be made by the study investigators using International RLS study group criteria. Patients with augmentation on dopaminergic therapy as defined by NIH 2007 with ASRS of 5 to 15 will be offered to participate in the study. Inclusion and exclusion criteria are listed below. The study will be performed after approval of the Institutional Review Board of the University of Missouri.

A total of 50 subjects will be entered into the study over a period of 1 year. Written consent will be obtained from all patients. After pre-participation evaluation for eligibility, subjects will be selected and enrolled in the study and followed for a total of 6 follow up visits (Days 0, 30, 90, 120, 180, 360). Subjects Enrollment period will last up to 12 months. The total duration of study will be 24 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Examine the Effect of Horizant (Gabapentin Enacarbil) in Primary Restless Legs Syndrome (RLS) Patients Who Are on Dopaminergic Agents and Exhibiting Augmentation
Study Start Date : January 2016
Actual Primary Completion Date : May 6, 2019
Actual Study Completion Date : May 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs

Arm Intervention/treatment
open-label

open-label single arm study

Horizant, 600 mg oral once daily at 5 pm for 360 days.

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).

Other Name: Gabapentin enacarbil




Primary Outcome Measures :
  1. The Efficacy of Dopamine Combined Therapy with Addition of Horizant on Augmentation [ Time Frame: From Day 0 (Baseline) to Day 90 ]
    1. A reduction in the Augmentation Severity Rating Scale (ASRS)
    2. Improvement in the International Restless Legs Syndrome-Rating Scale(IRLS)
    3. Improvement in the Restless Legs Syndrome-Quality of Life (RLS-QOL)
    4. Improvement in the Medical Outcome Study-Sleep Scale (MOS-SS)


Secondary Outcome Measures :
  1. The Efficacy of Horizant Alone with Dopaminergic (DA) Taper on Augmentation [ Time Frame: From Day 120 to Day 360 ]
    1. A reduction in the Augmentation Severity Rating Scale (ASRS)
    2. Improvement in the International Restless Legs Syndrome-Rating Scale (IRLS)
    3. Improvement in the Restless Legs Syndrome-Quality of Life (RLS-QOL)
    4. Improvement in the Medical Outcome Study-Sleep Scale (MOS-SS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642315


Locations
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United States, Missouri
University of Missouri Health Care
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Pradeep Sahota, MD University of Missouri Health Care
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Responsible Party: Pradeep Sahota, Professor & Chairman, Dept. of Neurology, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02642315    
Other Study ID Numbers: 0046783
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Psychomotor Agitation
Restless Legs Syndrome
Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents