ClinicalTrials.gov
ClinicalTrials.gov Menu

Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome (XP081)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01332305
Recruitment Status : Completed
First Posted : April 11, 2011
Results First Posted : May 26, 2011
Last Update Posted : July 22, 2013
Sponsor:
Information provided by (Responsible Party):
XenoPort, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Restless Legs Syndrome
Interventions Drug: GEn (XP13512/GSK1838262)
Drug: Placebo
Enrollment 217
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GEn Placebo GEn 600 mg GEn 1200 mg GEn 1800 mg GEn 2400 mg
Hide Arm/Group Description Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet. Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet. Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet. Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet. Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
Period Title: Overall Study
Started 41 48 45 38 45
Completed 31 34 31 30 33
Not Completed 10 14 14 8 12
Reason Not Completed
Adverse Event             1             4             6             3             5
Withdrawal by Subject             6             5             4             1             0
Lost to Follow-up             0             2             3             2             3
Protocol Violation             1             2             1             0             3
Withdrawal by Sponsor             1             0             0             1             1
Treatment Failure             1             1             0             0             0
Physician Decision             0             0             0             1             0
Arm/Group Title GEn Placebo GEn 600 mg GEn 1200 mg GEn 1800 mg GEn 2400 mg Total
Hide Arm/Group Description Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet. Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet. Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet. Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet. Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet. Total of all reporting groups
Overall Number of Baseline Participants 41 48 45 38 45 217
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 48 participants 45 participants 38 participants 45 participants 217 participants
47.1  (11.16) 47.3  (12.78) 49.8  (11.51) 50.2  (13.79) 45.9  (13.93) 48.0  (12.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 48 participants 45 participants 38 participants 45 participants 217 participants
Female
29
  70.7%
31
  64.6%
23
  51.1%
27
  71.1%
29
  64.4%
139
  64.1%
Male
12
  29.3%
17
  35.4%
22
  48.9%
11
  28.9%
16
  35.6%
78
  35.9%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 48 participants 45 participants 38 participants 45 participants 217 participants
White or Caucasian 39 48 44 35 42 208
Black or African American 1 0 1 2 2 6
American Indian or Alaska Native 1 0 0 0 1 2
Asian 0 0 0 1 1 2
[1]
Measure Description: There was one participant in the GEn 2400 mg arm who was categorized in more than one race.
1.Primary Outcome
Title Mean Css, Max and Css, Min
Hide Description Css, max is defined as the maximum or “peak” concentration of a drug observed after multiple administration, at steady state. Css, max is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Css, min is defined as the minimum concentration of a drug observed after its administration, in steady state. ng, nanograms; PK, pharmacokinetic; W, week; BLQ, below limit of quantitation.
Time Frame Weeks 4 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants (par.) who were randomized and received at least one (or any portion of a) dose of study drug. Population was analyzed as randomized. Placebo par. had no exposure to GEn and were not included in the PK assessments. Of par. who completed the study, some were not included at W12 (sample not taken or BLQ).
Arm/Group Title GEn Placebo GEn 600 mg GEn 1200 mg GEn 1800 mg GEn 2400 mg
Hide Arm/Group Description:
Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
Overall Number of Participants Analyzed 0 39 33 33 36
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/ml)
Css, max; Week 4, n=0, 39, 33, 33, 36 3.86  (1.25) 7.14  (2.62) 11.4  (3.54) 14.0  (4.23)
Css, max; Week 12, n=0, 32, 30, 30, 31 4.14  (1.19) 7.15  (2.76) 12.0  (3.83) 13.3  (3.83)
Css, min; Week 4, n=0, 39, 33, 33, 36 0.690  (0.359) 1.37  (0.894) 1.63  (0.967) 2.34  (1.78)
Css, min; Week 12, n=0, 32, 30, 30, 31 0.600  (0.332) 1.32  (1.15) 1.60  (0.994) 2.41  (1.29)
2.Primary Outcome
Title Mean Tmax and T1/2
Hide Description Tmax is defined as the time to the maximum or “peak” concentration of a drug observed after multiple administration. T1/2 is defined as the time to when half of the total amount of a particular substance is eliminated from the body.
Time Frame Weeks 4 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Placebo participants (par.) were not included in the PK assessments, as they had no exposure to GEn. At W4, there were two par. excluded from the T1/2, as a result of no sample taken or a PK profile not possible. Of par. who completed the study, some were not included at W12 (sample not taken or below limit of quantitation).
Arm/Group Title GEn Placebo GEn 600 mg GEn 1200 mg GEn 1800 mg GEn 2400 mg
Hide Arm/Group Description:
Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
Overall Number of Participants Analyzed 0 39 33 33 36
Mean (Standard Deviation)
Unit of Measure: hours
Tmax; Week 4, n=0, 39, 33, 33, 36 8.76  (3.81) 8.57  (3.16) 7.61  (2.67) 8.01  (3.62)
Tmax; Week 12, n=0, 32, 30, 30, 31 6.96  (3.76) 8.72  (3.68) 8.00  (2.58) 8.13  (3.20)
T1/2; Week 4, n=0, 38, 33, 33, 35 5.82  (1.46) 6.67  (1.94) 5.82  (1.56) 6.05  (1.11)
T1/2, Week 12, n=0, 32, 30, 30, 30 6.27  (1.77) 6.63  (2.23) 5.89  (1.36) 6.09  (1.28)
3.Primary Outcome
Title Mean AUCss
Hide Description The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUCss is the area under the curve during the steady-state period. The AUCss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUCss used concentration data from 0 to 24 hours at steady-state for Weeks 4 and 12.
Time Frame Weeks 4 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Placebo participants were not included in the PK assessments, as they had no exposure to GEn. Of participants who completed the study, some were not included at Week 12 (sample not taken or below limit of quantitation).
Arm/Group Title GEn Placebo GEn 600 mg GEn 1200 mg GEn 1800 mg GEn 2400 mg
Hide Arm/Group Description:
Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
Overall Number of Participants Analyzed 0 38 33 33 35
Mean (Standard Deviation)
Unit of Measure: ng*hour/ml
Week 4, n=0, 38, 33, 33, 35 49.3  (14.8) 96.1  (30.4) 141  (41.0) 176  (53.8)
Week 12, n=0, 32, 30, 30, 30 51.4  (16.5) 95.7  (38.5) 146  (41.4) 173  (54.4)
Time Frame Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
Adverse Event Reporting Description At the end of the follow-up period (30 days after the last day of taper [Day 119]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
 
Arm/Group Title GEn Placebo GEn 600 mg GEn 1200 mg GEn 1800 mg GEn 2400 mg
Hide Arm/Group Description Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet. Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet. Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet. Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet. Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
All-Cause Mortality
GEn Placebo GEn 600 mg GEn 1200 mg GEn 1800 mg GEn 2400 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GEn Placebo GEn 600 mg GEn 1200 mg GEn 1800 mg GEn 2400 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/41 (2.44%)   0/48 (0.00%)   1/45 (2.22%)   0/38 (0.00%)   1/45 (2.22%) 
Hepatobiliary disorders           
Cholelithiasis  1  0/41 (0.00%)  0/48 (0.00%)  1/45 (2.22%)  0/38 (0.00%)  0/45 (0.00%) 
Musculoskeletal and connective tissue disorders           
Rotator cuff syndrome  1  0/41 (0.00%)  0/48 (0.00%)  0/45 (0.00%)  0/38 (0.00%)  1/45 (2.22%) 
Vascular disorders           
Peripheral vascular disorder  1  1/41 (2.44%)  0/48 (0.00%)  0/45 (0.00%)  0/38 (0.00%)  0/45 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GEn Placebo GEn 600 mg GEn 1200 mg GEn 1800 mg GEn 2400 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/41 (51.22%)   24/48 (50.00%)   33/45 (73.33%)   25/38 (65.79%)   42/45 (93.33%) 
Ear and labyrinth disorders           
Vertigo  1  0/41 (0.00%)  0/48 (0.00%)  0/45 (0.00%)  2/38 (5.26%)  2/45 (4.44%) 
Eye disorders           
Vision blurred  1  0/41 (0.00%)  0/48 (0.00%)  2/45 (4.44%)  0/38 (0.00%)  4/45 (8.89%) 
Gastrointestinal disorders           
Nausea  1  5/41 (12.20%)  3/48 (6.25%)  4/45 (8.89%)  3/38 (7.89%)  3/45 (6.67%) 
Diarrhea  1  4/41 (9.76%)  1/48 (2.08%)  3/45 (6.67%)  2/38 (5.26%)  2/45 (4.44%) 
Dry mouth  1  1/41 (2.44%)  0/48 (0.00%)  2/45 (4.44%)  2/38 (5.26%)  3/45 (6.67%) 
Constipation  1  0/41 (0.00%)  1/48 (2.08%)  3/45 (6.67%)  2/38 (5.26%)  0/45 (0.00%) 
Vomiting  1  1/41 (2.44%)  0/48 (0.00%)  1/45 (2.22%)  2/38 (5.26%)  1/45 (2.22%) 
General disorders           
Fatigue  1  4/41 (9.76%)  2/48 (4.17%)  4/45 (8.89%)  1/38 (2.63%)  2/45 (4.44%) 
Irritability  1  2/41 (4.88%)  2/48 (4.17%)  3/45 (6.67%)  2/38 (5.26%)  2/45 (4.44%) 
Feeling drunk  1  0/41 (0.00%)  0/48 (0.00%)  0/45 (0.00%)  3/38 (7.89%)  4/45 (8.89%) 
Peripheral edema  1  1/41 (2.44%)  0/48 (0.00%)  2/45 (4.44%)  1/38 (2.63%)  3/45 (6.67%) 
Feeling abnormal  1  0/41 (0.00%)  0/48 (0.00%)  2/45 (4.44%)  3/38 (7.89%)  1/45 (2.22%) 
Non-cardiac chest pain  1  1/41 (2.44%)  1/48 (2.08%)  0/45 (0.00%)  0/38 (0.00%)  3/45 (6.67%) 
Pyrexia  1  0/41 (0.00%)  0/48 (0.00%)  3/45 (6.67%)  1/38 (2.63%)  0/45 (0.00%) 
Infections and infestations           
Nasopharyngitis  1  3/41 (7.32%)  1/48 (2.08%)  3/45 (6.67%)  3/38 (7.89%)  2/45 (4.44%) 
Sinusitis  1  1/41 (2.44%)  1/48 (2.08%)  3/45 (6.67%)  0/38 (0.00%)  3/45 (6.67%) 
Musculoskeletal and connective tissue disorders           
Muscle spasms  1  1/41 (2.44%)  4/48 (8.33%)  2/45 (4.44%)  0/38 (0.00%)  1/45 (2.22%) 
Pain in extremity  1  1/41 (2.44%)  2/48 (4.17%)  2/45 (4.44%)  2/38 (5.26%)  0/45 (0.00%) 
Nervous system disorders           
Somnolence  1  2/41 (4.88%)  7/48 (14.58%)  11/45 (24.44%)  10/38 (26.32%)  23/45 (51.11%) 
Dizziness  1  1/41 (2.44%)  10/48 (20.83%)  10/45 (22.22%)  10/38 (26.32%)  18/45 (40.00%) 
Headache  1  7/41 (17.07%)  2/48 (4.17%)  9/45 (20.00%)  4/38 (10.53%)  6/45 (13.33%) 
Sedation  1  1/41 (2.44%)  0/48 (0.00%)  0/45 (0.00%)  3/38 (7.89%)  3/45 (6.67%) 
Disturbance in attention  1  0/41 (0.00%)  1/48 (2.08%)  0/45 (0.00%)  2/38 (5.26%)  0/45 (0.00%) 
Psychiatric disorders           
Insomnia  1  1/41 (2.44%)  5/48 (10.42%)  1/45 (2.22%)  1/38 (2.63%)  1/45 (2.22%) 
Disorientation  1  1/41 (2.44%)  0/48 (0.00%)  1/45 (2.22%)  2/38 (5.26%)  1/45 (2.22%) 
Depression  1  0/41 (0.00%)  0/48 (0.00%)  3/45 (6.67%)  0/38 (0.00%)  1/45 (2.22%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: XenoPort Call Center
Organization: XenoPort, Inc.
Phone: 877-936-6778
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: XenoPort, Inc.
ClinicalTrials.gov Identifier: NCT01332305     History of Changes
Other Study ID Numbers: 111462
First Submitted: April 7, 2011
First Posted: April 11, 2011
Results First Submitted: April 28, 2011
Results First Posted: May 26, 2011
Last Update Posted: July 22, 2013