Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in Restless Legs Syndrome

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Restless Legs Syndrome

In brief

This is a phase IV single-blind, placebo run-in fixed dose single-group study to assess objective and subjective effects of GEn on sleep EEG, BP, and anterior tibialis EMG responsivity in patients with RLS. The study will include 8 visits over a period of up to 8 weeks for eligible subjects including a 1 to 3-week Screening/Washout Period, a 1-week placebo run-in period, and a 4-week Treatment Period.The first placebo dose will be administered within 1 to 3 weeks after Screening/Washout. The total duration of the study from the first subject enrolled to the last subject completed will be approximately 1 year.

Key facts

Study ID: NCT02424695
Run by: Cleveland Sleep Research Center
People needed: 20
Starts: 2015-06-01
Expected to finish: 2016-07-01
Last updated by the study team: 2015-04-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female subjects ages 18 to 65 years with a diagnosis of primary moderate to severe RLS
A minimum of 6-month history of RLS symptoms
IRLS score >15 points (at visits 1 and 2) and a score of > 2 on item 4
RLS symptoms on at least 15 days during the month prior to screening (or if on treatment, similar symptom frequency before the start of treatment)
RLS symptoms for >4 out of 7 evenings /day during the week prior to screening
History of sleep disturbance due to RLS over the last 3 months
Subjective history of WASO ≥ 60 min; TST < 6.5 hours; subjective sleep latency ≥ 30 min on at least 3 nights per week within the last 3 months
Subjective complaint of WASO ≥ 60 min; TST< 6.5 hours; subjective sleep latency ≥ 30 min on at least 3 nights out of 7on the SSQ during the 1 week prior to Visit 2
Objective WASO of ≥30 minutes, TST < 6.5 hours and PLMI ≥ 10 during adaptation in baseline PSG 1
Females of child bearing potential willing to use birth control
Subject can read understand and sign consent form
Subject able to complete the study and to comply with study instructions and procedures

You may not qualify if…

Subject has an apnea-hypopnea index of ≥10/ hour during adaptation/baseline night PSGs. Subjects with OSA controlled by CPAP will be accepted
Evidence of secondary RLS
Subject has any of the following medical conditions, laboratory abnormalities or disorders:
Hepatic impairment Impaired renal function or renal dysfunction requiring hemodialysis; Serum ferritin level <20 mcg/L (ng/mL)
Clinically significant ECG abnormalities
Any unstable medical condition that could impact subject's safety and study outcomes
Uncontrolled hypertension at Screening or at time of treatment initiation
Subjects diagnosed with additional sleep disorders other than RLS-associated sleep disturbance
Neurologic disease or movement disorder, rheumatoid arthritis, fibromyalgia, uncontrolled psychiatric illness, current diagnosis or history of epilepsy or seizure disorder
Chronic hepatitis B or hepatitis C
Subject currently suffering from moderate or severe depression
Subject unable to discontinue prohibited medications during the Screening period and throughout the duration of the study.
Subject has consumed food or beverages containing more than 400 mg of caffeine or other xanthines (e.g., coffee, cola, tea, chocolate) per day over the preceding month prior to Screening or unwilling to refrain from consuming any caffeinated food or beverage within 8 hours prior to any PSG assessment.
Subject has typical consumption of >14 alcoholic units in any week, or more than 5 alcoholic units in any single day, over the month preceding the Screening visit or unwilling to refrain from consuming alcohol within 24 hours of any PSG assessment
Night workers, shift workers or any others whose sleeping habits are incompatible with the study design, or who would be required to make significant changes to their bedtime during the course of the study
Subject who might be non-compliant with the visit schedule, procedures, or medication administration
Subject is a pregnant or nursing female
A history of allergy or medically significant adverse reaction or intolerance to gabapentin or GEn
A history of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence within the past year
A history of augmentation or early morning rebound of RLS symptoms without a history of prior response to treatment.
Subject has received previous treatment with levodopa/carbidopa, dopamine agonists, pregabalin, gabapentin or GEn in the 3 weeks prior to Visit
Subject has received' other treatments for RLS (e.g., opioids, benzodiazepines) at least 2 weeks prior to Visit 2
Participation in any clinical drug or device trial within 30 days prior to Baseline

Where it is running

Cleveland Sleep Research Center — Middleburg Heights, Ohio, United States

Full record on ClinicalTrials.gov

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