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

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ClinicalTrials.gov Identifier: NCT02117076
Recruitment Status : Terminated (Recruitment not successful due to overly restrictive inclusion/exclusion criteria.)
First Posted : April 17, 2014
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Theresa Zesiewicz, 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.

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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

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 ]

Secondary Outcome Measures :
  1. Restless Leg Syndrome Quality of Life Scale (RLSQoL) [ Time Frame: Baseline, day 35, day 54. ]

Other Outcome Measures:
  1. Medical Outcomes Study (MOS) Sleep Scale [ Time Frame: Baseline, day 35, day 54 ]


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.


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

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


Locations
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United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Theresa Zesiewicz
Investigators
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Principal Investigator: Theresa Zesiewicz, MD, FAAN University of South Florida

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Responsible Party: Theresa Zesiewicz, 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: June 29, 2016
Last Verified: June 2016
Keywords provided by Theresa Zesiewicz, University of South Florida:
Restless leg syndrome
RLS
gabapentin
gabapentin enacarbil
Neurontin
Horizant
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
Signs and Symptoms
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