Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
XenoPort, Inc.
ClinicalTrials.gov Identifier:
NCT00748098
First received: September 5, 2008
Last updated: July 15, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.


Condition Intervention Phase
Restless Legs Syndrome
Restless Legs Syndrome (RLS)
Drug: GSK1838262 Extended Release Tablets
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study RXP110908, a Polysomnography Study of GSK1838262 (XP13512) Extended Release Tablets Versus Placebo in the Treatment of Restless Legs Syndrome (RLS) and Associated Sleep Disturbance

Resource links provided by NLM:


Further study details as provided by XenoPort, Inc.:

Primary Outcome Measures:
  • Adjusted Mean Change From Baseline in Wake Time During Sleep (WTDS) at Week 4/10 Measured by Polysomnography (PSG) (Sleep Study) Using Last Observation Carried Forward (LOCF) [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    PSG is a comprehensive recording of the bio-physiological changes that occur during sleep. It is also known as a "sleep study" that monitors participants as they sleep or try to sleep. WTDS, defined as the total amount of time spent awake after falling asleep until the last awakening, was measured by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.


Secondary Outcome Measures:
  • Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    PLMAI is defined as the number of Periodic Limb Movements (PLMs or involuntary jerks of the legs that cause a participant to arouse from sleep per hour of sleep). Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

  • Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    The IRLS is a measure of RLS disease severity. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

  • Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    The IRLS is a measure of RLS disease severity. Item 4 of the IRLS evaluates RLS-related sleep impairment. It asks: "In the past week, how severe was your sleep disturbance due to your RLS symptoms?". The item is participant rated using a 5-point scale, where 0 is the absence of any sleep disturbance and 4 is very severe disturbance. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

  • Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    Stage N1 is considered "light sleep," during which participants drift in and out of sleep and can be awakened easily. In this stage, the eyes move slowly and muscle activity slows. This stage is sometimes referred to as "somnolence" or "drowsy sleep." Sudden twitches and hypnic jerks may be associated with the onset of sleep during N1. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

  • Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N1 Sleep Stage at Week 4/10 Using LOCF [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    Percentage of stage N1 sleep time was defined as the time spent in stage N1 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

  • Adjusted Mean Change From Baseline in Time Spent in the N2 Sleep Stage as Measured by Polysomnography at Week 4/10 Using LOCF [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    In stage N2 of sleep, eye movement stops and brain waves become slower, with only an occasional burst of rapid brain waves. Participants may also experience spontaneous periods of muscle tone mixed with periods of muscle relaxation. During this stage, muscular activity, and conscious awareness of the external environment disappears. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

  • Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N2 Sleep Stage at Week 4/10 [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    Percentage of stage N2 sleep time was defined as the time spent in stage N2 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

  • Mean Change From Baseline in the Total Time Spent in Stage N3 Sleep Time at Week 4/10 Measured by PSG Using LOCF [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    Stage N3 is referred to as deep sleep; it is very difficult to wake a participant in this stage of sleep. In deep sleep, there is no eye movement or muscle activity. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

  • Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N3 Sleep Stage at Week 4/10 [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    Percentage of stage N3 sleep time was defined as the time spent in stage N3 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

  • Adjusted Mean Change From Baseline in Time Spent in the REM (Rapid Eye Movement) Sleep Stage at Week 4/10 as Measured by Polysomnography Using LOCF [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    In REM sleep, a participant's breathing becomes more rapid, irregular, and shallow; eyes jerk rapidly; and limb muscles are temporarily paralyzed. Brain waves during this stage increase to levels experienced when a person is awake. This is the stage when most dreams occur. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

  • Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the REM Sleep Stage at Week 4/10 [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    Percentage of stage REM sleep time was defined as the time spent in stage REM sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

  • Adjusted Mean Change From Baseline in Periodic Limb Movements Causing Awakening (PLMAWI) at Week 4/10 as Measured by Polysomnography Using LOCF [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    PLMAWI is defined as the number of PLMs (involuntary leg movements) that caused participants to wake up per hour of sleep. It is calculated by dividing the number of PLMs causing awakening by the total number of hours of sleep. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

  • Number of PLMAI Responders at Week 4/10 Using LOCF [ Time Frame: Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    PLMAI is defined as the number of PLMs associated with arousal per hour of sleep. Participants with <=5 PLMAI were evaluated as responders.

  • Adjusted Mean Change From Baseline in Sleep Quality at Week 4/10 as Measured by the Subjective Post Sleep Diary (SPSD) Using LOCF [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    Each day upon awakening, participants rated their overall sleep quality for the previous night on an 11-point scale (0=poor to 10=excellent) using the SPSD. Response to sleep quality was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

  • Adjusted Mean Change From Baseline in Participant's Ratings of Feeling Rested Upon Awakening as Measured by the Subjective Post Sleep Diary (SPSD) at Week 4/10 Using LOCF. [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    Each day upon awakening, participants rated how rested they felt upon awakening on an 11-point scale (0=poor to 10=excellent) using the SPSD. Response to feeling rested upon awakening was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

  • Adjusted Mean Change From Baseline in the Number of Awakenings Measured Objectively by Polysomnography at Week 4/10 Using LOCF [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    The number of awakenings was measured by PSG and is defined as the number of wake periods lasting at least 1 minute. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

  • Adjusted Mean Change From Baseline in the Self-reported Number of Hours Spent Awake During the Night (SPSD) Due to RLS at Week 4/10 Using LOCF [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    Each day upon awakening, participants recorded, using the SPSD, the total number of hours spent awake the previous night due to RLS. Response to number of hours awake was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

  • Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF [ Time Frame: Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    Each day upon awakening, participants recorded, using the SPSD, the number of awakenings due to RLS they experienced the previous night. Number of awakenings was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis.

  • Adjusted Mean Change From Baseline in the Total Sleep Time Measured by Polysomnography (PSG) at Week 4/10 Using LOCF [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    Total sleep time is the number of minutes participants slept on average during the 8-hour polysomnography. Scoring of PSG data to yield measure of total sleep time was conducted at a central site in the United States. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effect.

  • Adjusted Mean Change From Baseline in the Sleep Efficiency Measured by Polysomnography (PSG) at Week 4/10 Using LOCF [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    Sleep efficiency is a percentage that is calculated by dividing total sleep time by the amount of time the participant was in bed during the PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effect.

  • Adjusted Mean Change From Baseline in the Wake After Sleep Onset (WASO) Measured by Polysomnography (PSG) at Week 4/10 Using LOCF. [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    Wake After Sleep Onset (WASO) is defined as the total amount of time spent awake after falling asleep until the end of PSG recording. This endpoint is measured objectively by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects

  • Adjusted Mean Change From Baseline in the Suggested Immobilization Test (SIT) PLM Index at Week 4/10 [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    During the SIT, participants sat in bed with legs extended for 1 hour and were asked to rate their leg discomfort on a 100 millimeters visual analog scale every 5 minutes (score of 0-100, 0=none, higher numbers indicate more discomfort) and PLMs were assessed. The SIT-PLM Index is defined as the number of PLMs per hour during the SIT. Mean change from baseline was adjusted for treatment, pooled center, and period effects. Only results from SITs performed before a PSG assessment and of at least 60 minutes in length are included in the analysis.

  • Adjusted Mean Change From Baseline in the SIT MDS (Mean Leg Discomfort Score), Mean of Scores From 0 to 60 Minutes, at Week 4/10 [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    During the SIT, participants sat in bed with legs extended for 1 hour and rated their leg discomfort on a visual analog scale every 5 minutes (range 0-100, 0=none, higher numbers indicate more discomfort). The SIT MDS is the average rating of leg discomfort during the specified time frame. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. Only results from SITs performed before a PSG assessment and of at least 60 minutes in length are included in the analysis.

  • Number of Participants Who Responded Affirmatively to Each of the 4 Items of the Participant-completed Patient Global Impression of Therapy at Week 4/10 Using LOCF [ Time Frame: Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    Each participant completed the participant-completed Patient Global Impression questionnaire at the end of each Treatment Period (Weeks 4 and 10) or Early Withdrawal. This instrument was developed to capture a participant's subjective assessment of therapy and is composed of the following 4 questions with dichotomous (Yes or No) responses: "Helped me sleep," "Helped me fall asleep faster," "Helped me sleep longer," and "Helped me get a better night's sleep."

  • Adjusted Mean Change From Baseline in the Clinical Global Impression of Illness - Severity (CGI-S) Score at Week 4/10 Using LOCF [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    The CGI-S scale allows the investigator to rate the severity of participants' illness considering their total clinical experience with the participant population being studied and based on all information available at the time of rating. The scale is rated from 1-7 (1=Normal, not at all ill; 7=Among the most extremely ill patients). Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

  • Number of Participants Who Were Defined as Clinical Global Impression of Illness (CGI-I) Scale "Responders" at Week 4/10 Using LOCF [ Time Frame: Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    The CGI-I scale allows the investigator to rate the participant's global improvement or worsening compared with the condition at baseline (i.e., Day 1), and whether or not the change is thought to be due to treatment with study medication. The scale is rated from 1-7 (1=Very much improved to 7=Very much worse). Participants with a score of 1 ("Very much improved") or 2 ("Much improved") are considered to be responders.

  • Number of Participants Who Self-reported "Very Satisfied" or "Satisfied" With the Investigational Product at Week 4/10 Using LOCF [ Time Frame: Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] [ Designated as safety issue: No ]
    Participant satisfaction with RLS medication was captured on a seven-point ordinal scale. The scale asked "Overall, how satisfied are you with the medication you received for the treatment of your RLS symptoms during the study." The participant responses ranged from 1 ("Very satisfied") to 7 ("Very dissatisfied"). A "satisfied" response was scored a 2.


Enrollment: 136
Study Start Date: October 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
GSK1838262:placebo
GSK1838262 extended release tablets for Treatment Period 1 followed by Placebo for Treatment Period 2
Drug: Placebo
Placebo
Placebo:GSK1838262
Placebo for Treatment Period 1 followed by GSK1838262 for Treatment Period 2
Drug: GSK1838262 Extended Release Tablets
GSK1838262 extended release tablets
Other Names:
  • XP13512
  • gabapentin enacarbil

Detailed Description:

Double-blind, multi-center, placebo-controlled, 2-period crossover study which assessed the efficacy and safety of gabapentin enacarbil (GEn; GSK1838262; XP13512) extended release tablets in adults with Restless Legs Syndrome (RLS)-associated sleep disturbance. One hundred thirty-six (136) adult subjects with RLS-associated sleep disturbance and periodic limb movements (PLM) were randomized from 23 centers in the United States. Subjects who met all eligibility criteria were randomized to receive a treatment sequence of GEn:placebo or placebo:GEn. Investigational product was taken with food at approximately 5pm. Investigational product was dosed as 600mg/day x3 days followed by 1200mg/day x25 days for each 4-week treatment period. There was a 1-week taper at 600mg after each treatment period followed by a 1-week washout between treatments. Polysomnography (PSG) was used to objectively evaluate changes in sleep and PLMs.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Provided written informed consent.
  • Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
  • Have history of RLS symptoms at least 15 nights/month.
  • Minimum average of 15 Periodic Limb Movements during Sleep per hour (measured using actigraphy).

Exclusion criteria:

  • Secondary RLS
  • Primary sleep disorder
  • Sleep apnea
  • Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
  • Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
  • Use of any prohibited medication.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748098

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Jasper, Alabama, United States, 35501
United States, California
GSK Investigational Site
San Diego, California, United States, 92103
GSK Investigational Site
San Diego, California, United States, 92121
United States, Florida
GSK Investigational Site
Hallandale Beach, Florida, United States, 33009
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
GSK Investigational Site
Macon, Georgia, United States, 31201
United States, Kansas
GSK Investigational Site
Lenexa, Kansas, United States, 66214
GSK Investigational Site
Overland Park, Kansas, United States, 66211
United States, Kentucky
GSK Investigational Site
Crestview Hills, Kentucky, United States, 41017
GSK Investigational Site
Lexington, Kentucky, United States, 40509
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21224
GSK Investigational Site
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
GSK Investigational Site
Brighton, Massachusetts, United States, 02135
United States, Michigan
GSK Investigational Site
Kalamazoo, Michigan, United States, 49048
United States, New York
GSK Investigational Site
West Seneca, New York, United States, 14224
United States, North Carolina
GSK Investigational Site
Greenville, North Carolina, United States, 27835
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45245
GSK Investigational Site
Cleveland, Ohio, United States, 44130
GSK Investigational Site
Dublin, Ohio, United States, 43017
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, South Carolina
GSK Investigational Site
Columbia, South Carolina, United States, 29201
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78756
United States, Washington
GSK Investigational Site
Walla Walla, Washington, United States, 99362
Sponsors and Collaborators
XenoPort, Inc.
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
M Calloway; M Bharmal; C Hill-Zabala; R Allen. Development and Validation of a Subjective Post Sleep Diary to Assess Sleep Status in Subjects with Restless Legs Syndrome . [Sleep Med]. 2011;DOI 10.1016(/j.sleep.):2010.09.020.

Responsible Party: XenoPort, Inc.
ClinicalTrials.gov Identifier: NCT00748098     History of Changes
Other Study ID Numbers: RXP110908
Study First Received: September 5, 2008
Results First Received: April 21, 2011
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by XenoPort, Inc.:
PSG
Restless Legs Syndrome
gabapentin enacarbil
XP13512
GSK1838262
sleep disturbance
RLS
polysomnography

Additional relevant MeSH terms:
Restless Legs Syndrome
Sleep Disorders
Dyssomnias
Parasomnias
Psychomotor Agitation
Nervous System Diseases
Sleep Disorders, Intrinsic
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Dyskinesias
Psychomotor Disorders
Neurobehavioral Manifestations
Gabapentin
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on July 31, 2014