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Therapeutic Areas: Neurology | Family Medicine
Disease Category: Restless Leg Syndrome
Location: United States, FL

Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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

To Learn more

CW ID: 204750
Date Last Changed: March 8, 2016

Clinical Trial Snapshot

Phase
4
Gender
Both Male and Female
Age
18 to 80 Years
Overall Status
Recruiting
Facility Type
N/A

Eligibility

Inclusion Criteria:

  • Outpatients with a diagnosis of primary restless leg syndrome using the International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria
  • RLS symptoms ≥ 15 nights of the month prior to study enrollment and for ≥ 4 of 7 consecutive nights in the week prior to study enrollment (if untreated)
  • Age 18 years to 80 years
  • International Restless Legs Scale (IRLS) Total severity score of ≥ 15 (moderate to severe severity)
  • Had significant sleep disturbance on item 4 of IRLS
  • Women of child-bearing potential must use a reliable method of contraception
  • Informed consent. Subject must be willing and able to complete all study procedures.

Exclusion Criteria:

  • Any illness that in the investigator's opinion preclude participation in this study
  • Subjects with non-RLS-related sleep disorders (e.g., sleep apnea)
  • Subjects with neurological diseases or movement disorders other than RLS (e.g., diabetic neuropathy, Parkinson's disease, multiple sclerosis, dyskinesias, and dystonias)
  • Pregnancy or lactation
  • Concurrent participation in another clinical study
  • Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini-Mental State Examination scores less than 27)
  • Legal incapacity or limited legal capacity
  • History of RLS symptom augmentation or early-morning rebound with previous dopamine-agonist treatment
  • Clinically significant abnormalities in renal function
  • Presence of severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease
  • Concomitant treatment with drugs known to affect sleep/wake, RLS or periodic limb movements, including antidepressants. Subjects receiving treatment for RLS at screening will be required to discontinue and wash out for a minimum of 5 half-lives
  • Body mass index greater than 34 kg/m2

Contact

Jessica Shaw
University of South Florida - Morsani Center for Advanced Healthcare
13330 USF Laurel Drive
Tampa, FL 33612
Phone: (813)974-1414

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