Restless Leg Syndrome
Conditions
Keywords
Restless leg syndrome, RLS, gabapentin, gabapentin enacarbil, Neurontin, Horizant
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.
Interventions
DRUGGabapentin immediate release
up to 1200 mg per day
DRUGGabapentin enacarbil extended release
up to 1200 mg per day
Sponsors
Theresa Zesiewicz, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Restless Leg Syndrome Rating Scale (IRLS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Restless Leg Syndrome Quality of Life Scale (RLSQoL) | 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
| Measure | Time frame | Description |
|---|---|---|
| Medical Outcomes Study (MOS) Sleep Scale | 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. |
Countries
United States
Outcome results
None listed