Clinical trial NCT02117076: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Restless Leg Syndrome
Keywords: Restless leg syndrome
RLS
gabapentin
gabapentin enacarbil
Neurontin
Horizant
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2014-04-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: International Restless Leg Syndrome Rating Scale (IRLS)
timeFrame: 10 weeks
Secondary outcomes:
measure: Restless Leg Syndrome Quality of Life Scale (RLSQoL)
timeFrame: Baseline, day 35, day 54.
Other outcomes:
measure: Medical Outcomes Study (MOS) Sleep Scale
timeFrame: Baseline, day 35, day 54
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Theresa Zesiewicz, MD, FAAN
role: PRINCIPAL_INVESTIGATOR
References: