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

NCT02117076 | Terminated Phase 4

• 1 other identifier: RLS and Gabapentin or Horizant
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Restless Leg Syndrome

Keywords

Restless leg syndrome; RLS; gabapentin; gabapentin enacarbil; Neurontin; Horizant

Outcome Measures

Primary Outcomes (1)

• 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.

  10 weeks

Secondary Outcomes (1)

• Restless Leg Syndrome Quality of Life Scale (RLSQoL)

  Baseline, day 35, day 54.

Other Outcomes (1)

• Medical Outcomes Study (MOS) Sleep Scale

  Baseline, day 35, day 54

Study Arms (2)

gabapentin immediate release

ACTIVE COMPARATOR

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

gabapentin enacarbil extended release

ACTIVE COMPARATOR

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

Interventions

Gabapentin immediate release DRUG

up to 1200 mg per day

Also known as: Neurontin

gabapentin immediate release

Gabapentin enacarbil extended release DRUG

up to 1200 mg per day

Also known as: Horizant

gabapentin enacarbil extended release

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Theresa Zesiewicz, MD: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Theresa Zesiewicz, MD, FAAN

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurology, Director USf Ataxia Center

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 17, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

US (1)