We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02117076
Recruitment Status : Terminated (Recruitment unsuccessful due to overly restrictive inclusion/exclusion criteria.)
First Posted : April 17, 2014
Last Update Posted : November 16, 2021
Information provided by (Responsible Party):
Theresa Zesiewicz, MD, University of South Florida

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

Condition or disease Intervention/treatment Phase
Restless Leg Syndrome Drug: Gabapentin immediate release Drug: Gabapentin enacarbil extended release Phase 4

Detailed Description:
The study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin) versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome. Subjects will be randomized to gabapentin (IR) or Horizant™ (ER). Dosing will be blinded to both patient and study team members. Once study medication dosing has been optimized, subjects will then remain on a stable dose for six weeks until study endpoint, after which subjects will be down-titrated off of study medications.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizant™) in Restless Leg Syndrome
Study Start Date : April 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs

Arm Intervention/treatment
Active Comparator: gabapentin immediate release
Gabapentin IR is the immediate release form of the medication. Subjects randomized to gabapentin IR will be started out at a dose of 300mg per day, taken one hour before bedtime for the first week. Daily dose will be increased by 300 mg daily every 4 days until 1200 mg of gabapentin IR is reached or until a stable, tolerated dose of gabapentin IR that relieves symptoms has been maintained for 2 weeks (IRLS scores less than 15). Those patients who cannot tolerate gabapentin IR will be allowed to down titrate by one dose level (300 mg daily), before dropping out of the study.
Drug: Gabapentin immediate release
up to 1200 mg per day
Other Name: Neurontin

Active Comparator: gabapentin enacarbil extended release
Horizant is the extended release form of gabapentin enacarbil. Subjects randomized to Horizant will take 600mg at 5 pm. After four days of stable dosing of Horizant, subjects in this study group will be evaluated by phone for changes in RLS symptoms and Patient Global Impression scale to determine if a dose increase is warranted. Subjects in this group may be titrated up to 1200 mg daily during the 2 week titration period.
Drug: Gabapentin enacarbil extended release
up to 1200 mg per day
Other Name: Horizant

Primary Outcome Measures :
  1. International Restless Leg Syndrome Rating Scale (IRLS) [ Time Frame: 10 weeks ]

    The IRLS is a measure of severity of Restless Legs Syndrome. It includes 10 items, measured on a scale of 0-4. A score of 1-10 indicates mild severity, 11-20 indicates moderate severity, 21-30 is severe and 31-40 is very severe. Primary outcome is the difference in IRLS scores for each of the treatment regimens.

    from 0 to 4.

Secondary Outcome Measures :
  1. Restless Leg Syndrome Quality of Life Scale (RLSQoL) [ Time Frame: Baseline, day 35, day 54. ]
    The Restless Legs Syndrome Quality of Life questionnaire (RLSQoL) assesses the impact of RLS on daily life, emotional well-being, social life, and work life.

Other Outcome Measures:
  1. Medical Outcomes Study (MOS) Sleep Scale [ Time Frame: Baseline, day 35, day 54 ]
    The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 ( 1 = 0-15 min to more than 60 min) and Questions 2 to 12 are scored on a scale of 1 to 6 (1 = all of the time to 6 = none of the time. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7, and 8 and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Outpatients with a diagnosis of primary restless leg syndrome using the International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria8.
  2. 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).
  3. Age 18 years to 80 years.
  4. International Restless Legs Scale (IRLS) Total severity score of ≥ 15 (moderate to severe severity). 8
  5. Had significant sleep disturbance on item 4 of IRLS.8
  6. Women of child-bearing potential must use a reliable method of contraception.
  7. Informed consent. Subject must be willing and able to complete all study procedures.

Exclusion Criteria:

  1. Any illness that in the investigator's opinion preclude participation in this study.
  2. Subjects with non-RLS-related sleep disorders (e.g., sleep apnea)
  3. Subjects with neurological diseases or movement disorders other than RLS (e.g., diabetic neuropathy, Parkinson's disease, multiple sclerosis, dyskinesias, and dystonias)
  4. Pregnancy or lactation.
  5. Concurrent participation in another clinical study.
  6. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini-Mental State Examination scores less than 27).
  7. Legal incapacity or limited legal capacity.
  8. History of RLS symptom augmentation or early-morning rebound with previous dopamine-agonist treatment.
  9. Clinically significant abnormalities in renal function. 3,8,10
  10. Presence of severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease.
  11. 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.
  12. Body mass index greater than 34 kg/m2.

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): NCT02117076

Layout table for location information
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Theresa Zesiewicz, MD
Layout table for investigator information
Principal Investigator: Theresa Zesiewicz, MD, FAAN University of South Florida
Layout table for additonal information
Responsible Party: Theresa Zesiewicz, MD, Professor of Neurology, Director USf Ataxia Center, University of South Florida
ClinicalTrials.gov Identifier: NCT02117076    
Other Study ID Numbers: RLS and Gabapentin or Horizant
First Posted: April 17, 2014    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021
Keywords provided by Theresa Zesiewicz, MD, University of South Florida:
Restless leg syndrome
gabapentin enacarbil
Additional relevant MeSH terms:
Layout table for MeSH terms
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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