Trial Outcomes & Findings for XP13512 (Gabapentin Enacarbil) Extension Study in Patients With Restless Legs Syndrome. (NCT NCT00333359)

Last Updated: 2013-07-22

Results Overview

The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the Week 52 value minus the baseline value. Change scores with higher value represents greater improvement in RLS symptoms.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

581 participants

Primary outcome timeframe

Baseline and Week 52

Results posted on

2013-07-22

Participant Flow

Participants completing one of four parent studies (110963 \[NCT00298623\], 111460 \[NCT00365352\], 111462 \[NCT01332305\], and 111463 \[NCT01332318\]) were eligible to enroll in Study 111490 (NCT00333359) if eligibility criteria were met.

Participant milestones

Participant milestones
Measure	Naïve; 1200 mg GEn Naïve participants received placebo (therefore naïve to gabapentin enacarbil \[GEn\]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	Non-naïve; 1200 mg GEn Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
Overall Study STARTED	199	382
Overall Study COMPLETED	126	260
Overall Study NOT COMPLETED	73	122

Reasons for withdrawal

Reasons for withdrawal
Measure	Naïve; 1200 mg GEn Naïve participants received placebo (therefore naïve to gabapentin enacarbil \[GEn\]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	Non-naïve; 1200 mg GEn Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
Overall Study Adverse Event	29	35
Overall Study Withdrawal by Subject	19	37
Overall Study Physician Decision	2	2
Overall Study Protocol Non-compliance	2	8
Overall Study Lost to Follow-up	15	25
Overall Study Termination or Withdrawal by Sponsor	1	1
Overall Study Treatment Failure	3	8
Overall Study Withdrew before Receiving One Dose	2	6

Baseline Characteristics

XP13512 (Gabapentin Enacarbil) Extension Study in Patients With Restless Legs Syndrome.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naïve; 1200 mg GEn n=197 Participants Naïve participants received placebo (therefore naïve to gabapentin enacarbil \[GEn\]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	Non-naïve; 1200 mg GEn n=376 Participants Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	Total n=573 Participants Total of all reporting groups
Age Continuous	49.5 Years STANDARD_DEVIATION 12.03 • n=93 Participants	50.6 Years STANDARD_DEVIATION 11.82 • n=4 Participants	50.2 Years STANDARD_DEVIATION 11.89 • n=27 Participants
Sex: Female, Male Female	119 Participants n=93 Participants	217 Participants n=4 Participants	336 Participants n=27 Participants
Sex: Female, Male Male	78 Participants n=93 Participants	159 Participants n=4 Participants	237 Participants n=27 Participants
Race/Ethnicity, Customized White or Caucasian	192 participants n=93 Participants	360 participants n=4 Participants	552 participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	1 participants n=93 Participants	5 participants n=4 Participants	6 participants n=27 Participants
Race/Ethnicity, Customized Asian	1 participants n=93 Participants	3 participants n=4 Participants	4 participants n=27 Participants
Race/Ethnicity, Customized Black or African American	2 participants n=93 Participants	5 participants n=4 Participants	7 participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants
Race/Ethnicity, Customized Unknown	0 participants n=93 Participants	3 participants n=4 Participants	3 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and Week 52

Population: Safety Population: all participants who received one dose or any part of one dose of GEn. Week 52 (end of treatment) results included only Week 52 observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.

Outcome measures

Outcome measures
Measure	Naïve; 1200 mg GEn n=125 Participants Naïve participants received placebo (therefore naïve to gabapentin enacarbil \[GEn\]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	Non-naïve; 1200 mg GEn n=254 Participants Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	All Participants; 1200 mg GEn n=379 Participants All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC)	-16.3 points on a scale Standard Deviation 8.23	-17.0 points on a scale Standard Deviation 8.20	-16.8 points on a scale Standard Deviation 8.21

PRIMARY outcome

Timeframe: Weeks 0, 1, 4, 12, 24, 36, and 52

Population: Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.

The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being "very much improved" and a score of 7 being "very much worse" compared to the start of the study. Responders on the CGI-I are defined as those with a score of 1 or 2, corresponding to "very much improved" or "improved," respectively.

Outcome measures

Outcome measures
Measure	Naïve; 1200 mg GEn n=197 Participants Naïve participants received placebo (therefore naïve to gabapentin enacarbil \[GEn\]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	Non-naïve; 1200 mg GEn n=376 Participants Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	All Participants; 1200 mg GEn n=573 Participants All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC Week 0, n=197, 376, 573	84 participants	300 participants	384 participants
Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC Week 1, n=185, 363, 548	152 participants	294 participants	446 participants
Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC Week 4, n=171, 354, 525	143 participants	308 participants	451 participants
Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC Week 12, n=150, 324, 474	133 participants	297 participants	430 participants
Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC Week 24, n=138, 305, 443	126 participants	275 participants	401 participants
Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC Week 36, n=132, 281, 413	120 participants	260 participants	380 participants
Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC Week 52, n=126, 262, 388	115 participants	247 participants	362 participants

SECONDARY outcome

Timeframe: Weeks 0, 1, 4, 12, 24, and 36

The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the value at each visit minus the baseline value. Change scores with higher values represent greater improvement in RLS symptoms.

Outcome measures

Outcome measures
Measure	Naïve; 1200 mg GEn n=197 Participants Naïve participants received placebo (therefore naïve to gabapentin enacarbil \[GEn\]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	Non-naïve; 1200 mg GEn n=376 Participants Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	All Participants; 1200 mg GEn n=573 Participants All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC Week 1, n=186, 360, 546	-15.6 points on a scale Standard Deviation 7.44	-13.5 points on a scale Standard Deviation 8.47	-14.2 points on a scale Standard Deviation 8.19
Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC Week 0, n=197, 376, 573	-9.4 points on a scale Standard Deviation 8.08	-14.6 points on a scale Standard Deviation 8.40	-12.8 points on a scale Standard Deviation 8.64
Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC Week 4, n=174, 352, 526	-15.6 points on a scale Standard Deviation 7.72	-15.8 points on a scale Standard Deviation 7.80	-15.7 points on a scale Standard Deviation 7.77
Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC Week 12, n=150, 322, 472	-15.8 points on a scale Standard Deviation 8.76	-16.3 points on a scale Standard Deviation 7.84	-16.1 points on a scale Standard Deviation 8.14
Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC Week 24, n=139, 305, 444	-16.2 points on a scale Standard Deviation 7.53	-16.5 points on a scale Standard Deviation 7.80	-16.4 points on a scale Standard Deviation 7.71
Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC Week 36, n=130, 281, 411	-16.8 points on a scale Standard Deviation 7.79	-16.6 points on a scale Standard Deviation 8.23	-16.7 points on a scale Standard Deviation 8.09

SECONDARY outcome

Timeframe: Weeks 0, 1, and 52

The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being "very much improved," 2 being "much improved," 3 being "minimally improved," 4 being "no change," 5 being "minimally worse," 6 being "much worse," and 7 being "very much worse" compared to the start of the study.

Outcome measures

Outcome measures
Measure	Naïve; 1200 mg GEn n=197 Participants Naïve participants received placebo (therefore naïve to gabapentin enacarbil \[GEn\]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	Non-naïve; 1200 mg GEn n=376 Participants Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	All Participants; 1200 mg GEn n=573 Participants All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 52, Minimally worse, n=126, 262, 388	0 participants	0 participants	0 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 0, Very much improved, n=197, 376, 573	38 participants	192 participants	230 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 0, Much improved, n=197, 376, 573	46 participants	108 participants	154 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 0, Minimally improved, n=197, 376, 573	47 participants	37 participants	84 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 0, No change, n=197, 376, 573	55 participants	36 participants	91 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 0, Minimally worse, n=197, 376, 573	9 participants	0 participants	9 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 0, Much worse, n=197, 376, 573	2 participants	2 participants	4 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 0, Very much worse, n=197, 376, 573	0 participants	1 participants	1 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 1, Very much improved, n=185, 363, 548	82 participants	155 participants	237 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 1, Much improved, n=185, 363, 548	70 participants	139 participants	209 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 1, Minimally improved, n=185, 363, 548	28 participants	40 participants	68 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 1, No change, n=185, 363, 548	4 participants	25 participants	29 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 1, Minimally worse, n=185, 363, 548	0 participants	3 participants	3 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 1, Much worse, n=185, 363, 548	1 participants	1 participants	2 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 1, Very much worse, n=185, 363, 548	0 participants	0 participants	0 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 52, Very much improved, n=126, 262, 388	72 participants	187 participants	259 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 52, Much improved, n=126, 262, 388	43 participants	60 participants	103 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 52, Minimally improved, n=126, 262, 388	7 participants	9 participants	16 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 52, No change, n=126, 262, 388	4 participants	4 participants	8 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 52, Much worse, n=126, 262, 388	0 participants	1 participants	1 participants
Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC Week 52, Very much worse, n=126, 262, 388	0 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: Weeks 0, 1, 4, 12, 24, 36, and 52

Population: Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.

The Participant-rated CGI-I is a self-reported measure completed by the participant, who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being "very much improved" and a score of 7 being "very much worse". Responders on the Participant-rated CGI-I are defined as those with a score of 1 or 2, corresponding to "very much improved" and "improved," respectively.

Outcome measures

Outcome measures
Measure	Naïve; 1200 mg GEn n=197 Participants Naïve participants received placebo (therefore naïve to gabapentin enacarbil \[GEn\]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	Non-naïve; 1200 mg GEn n=376 Participants Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	All Participants; 1200 mg GEn n=573 Participants All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC Week 12, n=148, 318, 466	131 participants	283 participants	414 participants
Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC Week 36, n=129, 276, 405	115 participants	252 participants	367 participants
Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC Week 0, n=197, 376, 573	86 participants	304 participants	390 participants
Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC Week 1, n=182, 351, 533	145 participants	261 participants	406 participants
Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC Week 4, n=171, 348, 519	143 participants	299 participants	442 participants
Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC Week 24, n=133, 300, 433	117 participants	275 participants	392 participants
Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC Week 52, n=122, 247, 369	107 participants	227 participants	334 participants

SECONDARY outcome

Timeframe: Weeks 0, 1, and 52

The Participant-rated CGI-I is a self-reported measure completed by the participant who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being "very much improved," 2 being "much improved," 3 being "minimally improved," 4 being "no change," 5 being "minimally worse," 6 being "much worse," and 7 being "very much worse" compared to the start of the study.

Outcome measures

Outcome measures
Measure	Naïve; 1200 mg GEn n=197 Participants Naïve participants received placebo (therefore naïve to gabapentin enacarbil \[GEn\]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	Non-naïve; 1200 mg GEn n=376 Participants Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	All Participants; 1200 mg GEn n=573 Participants All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 0, Much improved, n=197, 376, 573	47 participants	110 participants	157 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 0, Minimally improved, =197, 376, 573	47 participants	35 participants	82 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 0, Minimally worse, n=197, 376, 573	8 participants	6 participants	14 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 1, Very much improved, n=182, 351, 533	91 participants	171 participants	262 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 1, No change, n=182, 351, 533	4 participants	28 participants	32 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 1, Much worse, n=182, 351, 533	2 participants	7 participants	9 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 52, Much improved, n=122, 247, 369	27 participants	50 participants	77 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 52, Minimally improved, n=122, 247, 369	11 participants	13 participants	24 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 52, No change, n=122, 247, 369	3 participants	5 participants	8 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 52, Minimally worse, n=122, 247, 369	0 participants	0 participants	0 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 52, Much worse, n=122, 247, 369	0 participants	1 participants	1 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 52, Very much worse, n=122, 247, 369	1 participants	1 participants	2 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 0, Very much improved, n=197, 376, 573	39 participants	194 participants	233 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 0, No change, n=197, 376, 573	50 participants	29 participants	79 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 0, Much worse, n=197, 376, 573	5 participants	1 participants	6 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 0, Very much worse, n=197, 376, 573	1 participants	1 participants	2 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 1, Much improved, n=182, 351, 533	54 participants	90 participants	144 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 1, Minimally improved, n=182, 351, 533	29 participants	48 participants	77 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 1, Minimally worse, n=182, 351, 533	1 participants	6 participants	7 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 1, Very much worse, n=182, 351, 533	1 participants	1 participants	2 participants
Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC Week 52, Very much improved, n=122, 247, 369	80 participants	177 participants	257 participants

SECONDARY outcome

Timeframe: Week 52

Population: Safety Population. Results at Week 52 include only Week 52 observed cases and do not include early termination values; as such, the number of participants with data at each time point differs from the number of participants in the Baseline Characteristics summary.

In the 24-Hour RLS Record (diary), participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hour intervals (8 AM to 12PM, 12 to 4PM, 4 to 8PM, 6 to 10PM, 8 to 12 Midnight, Midnight to 4AM, 4 to 8AM).

Outcome measures

Outcome measures
Measure	Naïve; 1200 mg GEn n=123 Participants Naïve participants received placebo (therefore naïve to gabapentin enacarbil \[GEn\]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	Non-naïve; 1200 mg GEn n=241 Participants Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	All Participants; 1200 mg GEn n=364 Participants All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data 8 AM to 12 PM, n=123, 241, 364	106 participants	224 participants	330 participants
Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data 12 PM to 4 PM, n=122, 240, 362	106 participants	216 participants	322 participants
Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data 4 PM to 8 PM, n=122, 240, 362	88 participants	184 participants	272 participants
Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data 6 PM to 10 PM, n=122, 241, 363	80 participants	175 participants	255 participants
Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data 8 PM to 12 AM, n=122, 241, 363	75 participants	162 participants	237 participants
Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data 12 AM to 4 AM, n=123, 241, 364	98 participants	195 participants	293 participants
Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data 4 AM to 8 AM, n=123, 241, 364	104 participants	214 participants	318 participants

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.

The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms for a 24-hour period, in 30-min increments, beginning at 8AM on the day prior to the visit.

Outcome measures

Outcome measures
Measure	Naïve; 1200 mg GEn n=127 Participants Naïve participants received placebo (therefore naïve to gabapentin enacarbil \[GEn\]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	Non-naïve; 1200 mg GEn n=285 Participants Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	All Participants; 1200 mg GEn n=412 Participants All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52 Week 24, n=127, 285, 412	15.5 hours Interval 0.0 to 21.0	20 hours Interval 0.0 to 24.0	18 hours Interval 0.0 to 24.0
Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52 Week 52, n=123, 241, 364	NA hours Interval 0.0 to 19.5 The median was not estimable with Kaplan-Meier methodology at Week 52 because fewer than 50% of participants experienced an event.	NA hours Interval 0.0 to 19.0 The median was not estimable with Kaplan-Meier methodology at Week 52 because fewer than 50% of participants experienced an event.	NA hours Interval 0.0 to 19.5 The median was not estimable with Kaplan-Meier methodology at Week 52 because fewer than 50% of participants experienced an event.

SECONDARY outcome

Timeframe: Weeks 24 and 52

The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL.

Outcome measures

Outcome measures
Measure	Naïve; 1200 mg GEn n=164 Participants Naïve participants received placebo (therefore naïve to gabapentin enacarbil \[GEn\]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	Non-naïve; 1200 mg GEn n=328 Participants Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	All Participants; 1200 mg GEn n=429 Participants All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52 Week 24, n=164, 328, 492	89.8 points on a scale Standard Deviation 12.27	91.1 points on a scale Standard Deviation 12.04	90.7 points on a scale Standard Deviation 12.12
Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52 Week 52, n=121, 264, 385	92.0 points on a scale Standard Deviation 9.77	92.0 points on a scale Standard Deviation 11.66	92.0 points on a scale Standard Deviation 11.09

SECONDARY outcome

Timeframe: Baseline and Weeks 24 and 52

The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Each summary score is expressed as a percentage and ranges from 0 to 100, with higher scores indicating more work missed; a negative change from baseline indicates less work missed. Change = the observed value at the current visit minus the observed value at Week 0. Change is calculated only for participants who had a value at both the current visit and at Week 0.

Outcome measures

Outcome measures
Measure	Naïve; 1200 mg GEn n=158 Participants Naïve participants received placebo (therefore naïve to gabapentin enacarbil \[GEn\]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	Non-naïve; 1200 mg GEn n=309 Participants Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	All Participants; 1200 mg GEn n=467 Participants All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores Week 24, Daily Activity Impairment, n=158,309,467	-10.3 percent change Standard Deviation 20.11	-4.3 percent change Standard Deviation 18.02	-6.3 percent change Standard Deviation 18.95
Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores Week 52, Work Time Missed, n=82, 175, 257	-0.2 percent change Standard Deviation 7.16	1.0 percent change Standard Deviation 9.86	0.6 percent change Standard Deviation 9.09
Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores Week 24, Work Time Missed, n=108, 199, 307	-0.2 percent change Standard Deviation 5.24	0.1 percent change Standard Deviation 4.88	0.0 percent change Standard Deviation 5.00
Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores Week 24, Impairment While Working, n=101, 185, 286	-7.6 percent change Standard Deviation 19.50	-2.3 percent change Standard Deviation 10.80	-4.2 percent change Standard Deviation 14.67
Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores Week 24, Overall Work Impairment, n=101, 185, 286	-7.6 percent change Standard Deviation 20.39	-2.2 percent change Standard Deviation 11.80	-4.1 percent change Standard Deviation 15.57
Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores Week 52, Impairment While Working n=78, 170, 248	-8.7 percent change Standard Deviation 18.26	-0.9 percent change Standard Deviation 5.61	-3.3 percent change Standard Deviation 16.85
Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores Week 52, Overall Work Impairment, n=78, 170, 248	-8.9 percent change Standard Deviation 19.25	-0.8 percent change Standard Deviation 17.03	-3.3 percent change Standard Deviation 18.12
Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores Week 52, Daily Activity Impairment, n=117,261,378	-11.5 percent change Standard Deviation 20.31	-3.9 percent change Standard Deviation 19.62	-6.3 percent change Standard Deviation 20.11

SECONDARY outcome

Timeframe: Baseline and Weeks 24 and 52

The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 24/52 minus the observed value at baseline. Absenteeism is recorded as the number of hours missed from work. W, Week; hr, hour.

Outcome measures

Outcome measures
Measure	Naïve; 1200 mg GEn n=108 Participants Naïve participants received placebo (therefore naïve to gabapentin enacarbil \[GEn\]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	Non-naïve; 1200 mg GEn n=199 Participants Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	All Participants; 1200 mg GEn n=307 Participants All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked W24, hr missed due to RLS, n=108, 199, 307	-0.1 hours Standard Deviation 1.08	-0.1 hours Standard Deviation 3.30	-0.1 hours Standard Deviation 2.73
Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked W24, hr missed for other reason, n=108, 199, 307	-1.8 hours Standard Deviation 8.94	-0.2 hours Standard Deviation 12.56	-0.8 hours Standard Deviation 11.43
Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked HW24, hr actually worked, n=108, 199, 307	0.8 hours Standard Deviation 18.09	2.5 hours Standard Deviation 17.60	1.9 hours Standard Deviation 17.76
Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked W52, hr missed due to RLS, n=82, 175, 257	0.1 hours Standard Deviation 2.39	0.2 hours Standard Deviation 4.10	0.2 hours Standard Deviation 3.64
Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked W52, hr missed other reason, n=82, 175, 257	0.5 hours Standard Deviation 10.78	-1.8 hours Standard Deviation 11.58	-1.0 hours Standard Deviation 11.36
Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked W52, hr actually worked, n=82, 175, 257	0.0 hours Standard Deviation 19.79	2.2 hours Standard Deviation 17.98	1.5 hours Standard Deviation 18.56

SECONDARY outcome

Timeframe: Baseline and Weeks 24 and 52

Population: Safety Population: all participants who received one dose or any part of one dose of GEn. Results include only observed cases and do not include early termination values; as such the number of participants analyzed at each week differs from the number of participants in the Baseline characteristics summary.

The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 52 minus the observed value at baseline. Productivity affected while working is estimated on a 0 (no effect) to 10 scale (completely preventing productivity).

Outcome measures

Outcome measures
Measure	Naïve; 1200 mg GEn n=197 Participants Naïve participants received placebo (therefore naïve to gabapentin enacarbil \[GEn\]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	Non-naïve; 1200 mg GEn n=376 Participants Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	All Participants; 1200 mg GEn n=573 Participants All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity Week 24, n=101, 185, 286	-0.8 points on a scale Standard Deviation 1.95	-0.2 points on a scale Standard Deviation 1.08	-0.4 points on a scale Standard Deviation 1.47
Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity Week 52, n=78, 170, 248	-0.9 points on a scale Standard Deviation 1.83	-0.1 points on a scale Standard Deviation 1.56	-0.3 points on a scale Standard Deviation 1.68

Adverse Events

Naïve; 1200 mg GEn

Serious events: 7 serious events

Other events: 114 other events

Deaths: 0 deaths

Non-naïve; 1200 mg GEn

Serious events: 14 serious events

Other events: 144 other events

Deaths: 0 deaths

All Participants; 1200 mg GEn

Serious events: 21 serious events

Other events: 258 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Naïve; 1200 mg GEn n=197 participants at risk Naïve participants received placebo (therefore naïve to gabapentin enacarbil \[GEn\]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	Non-naïve; 1200 mg GEn n=376 participants at risk Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.	All Participants; 1200 mg GEn n=573 participants at risk All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
Nervous system disorders Somnolence	27.4% 54/197 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.	15.7% 59/376 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.	19.7% 113/573 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
Nervous system disorders Dizziness	19.8% 39/197 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.	7.2% 27/376 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.	11.5% 66/573 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
Nervous system disorders Headache	7.6% 15/197 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.	6.9% 26/376 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.	7.2% 41/573 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
General disorders Fatigue	7.6% 15/197 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.	4.3% 16/376 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.	5.4% 31/573 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
Gastrointestinal disorders Nausea	5.1% 10/197 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.	5.3% 20/376 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.	5.2% 30/573 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
Infections and infestations Nasopharyngitis	4.1% 8/197 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.	5.3% 20/376 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.	4.9% 28/573 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
Infections and infestations Upper Respiratory Tract Infection	5.1% 10/197 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.	4.0% 15/376 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.	4.4% 25/573 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
Nervous system disorders Restless Legs Syndrome	7.1% 14/197 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.	2.7% 10/376 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.	4.2% 24/573 • Adverse event (AE) and serious adverse event (SAE) collection started immediately following informed consent and continued throughout the study (up to Week 53). At the end of the follow-up period, Week 57 (30 days after the last day of taper), the study coordinator called participants to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.

Additional Information

XenoPort Call Center

XenoPort, Inc.

Phone: 877-936-6778

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER