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

Primary Purpose

Restless Leg Syndrome

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gabapentin immediate release
Gabapentin enacarbil extended release
Sponsored by
Theresa Zesiewicz, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restless Leg Syndrome focused on measuring Restless leg syndrome, RLS, gabapentin, gabapentin enacarbil, Neurontin, Horizant

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of South Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

gabapentin immediate release

gabapentin enacarbil extended release

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

International Restless Leg Syndrome Rating Scale (IRLS)
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

Restless Leg Syndrome Quality of Life Scale (RLSQoL)
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.

Full Information

First Posted
April 15, 2014
Last Updated
November 8, 2021
Sponsor
Theresa Zesiewicz, MD
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1. Study Identification

Unique Protocol Identification Number
NCT02117076
Brief Title
Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizant™) in Restless Leg Syndrome
Official Title
Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizant™) in Restless Leg Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Recruitment unsuccessful due to overly restrictive inclusion/exclusion criteria.
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Theresa Zesiewicz, MD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Leg Syndrome
Keywords
Restless leg syndrome, RLS, gabapentin, gabapentin enacarbil, Neurontin, Horizant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gabapentin immediate release
Arm Type
Active Comparator
Arm Description
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.
Arm Title
gabapentin enacarbil extended release
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gabapentin immediate release
Other Intervention Name(s)
Neurontin
Intervention Description
up to 1200 mg per day
Intervention Type
Drug
Intervention Name(s)
Gabapentin enacarbil extended release
Other Intervention Name(s)
Horizant
Intervention Description
up to 1200 mg per day
Primary Outcome Measure Information:
Title
International Restless Leg Syndrome Rating Scale (IRLS)
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Restless Leg Syndrome Quality of Life Scale (RLSQoL)
Description
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.
Time Frame
Baseline, day 35, day 54.
Other Pre-specified Outcome Measures:
Title
Medical Outcomes Study (MOS) Sleep Scale
Description
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.
Time Frame
Baseline, day 35, day 54

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients with a diagnosis of primary restless leg syndrome using the International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria8. 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). 8 Had significant sleep disturbance on item 4 of IRLS.8 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. 3,8,10 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Zesiewicz, MD, FAAN
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

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

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