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The primary objective of this trial is to assess the long-term safety and efficacy of XP13512 (Gabapentin Enacarbil) taken once daily for the treatment of patients suffering from Restless Legs Syndrome (RLS).
Study XP055 is a multicenter, open-label, 52-week extension study of XP13512 (Gabapentin Enacarbil [GEn]) given once daily to eligible subjects with Restless Legs Syndrome (RLS) who had previously completed 1 of the following studies and met eligibility criteria: XP052 (110963 [NCT00298623]), XP053 (111460 [NCT00365352]), XP081 (111462 [NCT01332305]), and XP083 (111463 [NCT01332318]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XP13512 (GEn) | Experimental | 1200 mg XP13512, orally, once daily for 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XP13512 (GEn) | Drug | 1200 mg XP13512, orally, once daily for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC) | 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. | Baseline and Week 52 |
| Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | 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. | Weeks 0, 1, 4, 12, 24, 36, and 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21242741 | Background | Ellenbogen AL, Thein SG, Winslow DH, Becker PM, Tolson JM, Lassauzet ML, Chen D. A 52-week study of gabapentin enacarbil in restless legs syndrome. Clin Neuropharmacol. 2011 Jan-Feb;34(1):8-16. doi: 10.1097/WNF.0b013e3182087d48. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Non-naïve; 1200 mg GEn |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | The Safety Population, consisting of all participants who were enrolled in the study and took at least 1 dose (or any portion of a dose) of study medication, was used for summarizing all baseline characteristics. Eight enrolled participants did not meet the criteria for inclusion in the Safety Population. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC) | 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. | 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. | Posted | Mean | Standard Deviation | points on a scale | Baseline and Week 52 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| XenoPort Call Center | XenoPort, Inc. | 877-936-6778 |
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| C493250 | 1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid |
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| Weeks 0, 1, 4, 12, 24, and 36 |
| Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | 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. | Weeks 0, 1, and 52 |
| Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | 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. | Weeks 0, 1, 4, 12, 24, 36, and 52 |
| Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | 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. | Weeks 0, 1, and 52 |
| 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 | 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). | Week 52 |
| Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52 | 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. | Weeks 24 and 52 |
| Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at 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. | Weeks 24 and 52 |
| Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | 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. | Baseline and Weeks 24 and 52 |
| 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 | 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. | Baseline and Weeks 24 and 52 |
| Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity | 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). | Baseline and Weeks 24 and 52 |
| Physician Decision |
|
| Protocol Non-compliance |
|
| Lost to Follow-up |
|
| Termination or Withdrawal by Sponsor |
|
| Treatment Failure |
|
| Withdrew before Receiving One Dose |
|
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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | The Safety Population, consisting of all participants who were enrolled in the study and took at least 1 dose (or any portion of a dose) of study medication, was used for summarizing all baseline characteristics. Eight enrolled participants did not meet the criteria for inclusion in the Safety Population. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | The Safety Population, consisting of all participants who were enrolled in the study and took at least 1 dose (or any portion of a dose) of study medication, was used for summarizing all baseline characteristics. Eight enrolled participants did not meet the criteria for inclusion in the Safety Population. | Number | participants |
|
| OG000 | 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. |
| OG001 | 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. |
| OG002 | All Participants; 1200 mg GEn | 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. |
|
|
| Primary | Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC | 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. | 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. | Posted | Number | participants | Weeks 0, 1, 4, 12, 24, 36, and 52 |
|
|
|
| Secondary | Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC | 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. | 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. | Posted | Mean | Standard Deviation | points on a scale | Weeks 0, 1, 4, 12, 24, and 36 |
|
|
|
| Secondary | Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC | 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. | 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. | Posted | Number | participants | Weeks 0, 1, and 52 |
|
|
|
| Secondary | Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC | 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. | 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. | Posted | Number | participants | Weeks 0, 1, 4, 12, 24, 36, and 52 |
|
|
|
| Secondary | Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC | 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. | 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. | Posted | Number | participants | Weeks 0, 1, and 52 |
|
|
|
| Secondary | 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 | 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). | 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. | Posted | Number | participants | Week 52 |
|
|
|
| Secondary | Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52 | 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. | 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. | Posted | Median | Full Range | hours | Weeks 24 and 52 |
|
|
|
| Secondary | Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at 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. | 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. | Posted | Mean | Standard Deviation | points on a scale | Weeks 24 and 52 |
|
|
|
| Secondary | Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline and Weeks 24 and 52 |
|
|
|
| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | hours | Baseline and Weeks 24 and 52 |
|
|
|
| Secondary | Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity | 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). | 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. | Posted | Mean | Standard Deviation | points on a scale | Baseline and Weeks 24 and 52 |
|
|
|
| 7 |
| 197 |
| 114 |
| 197 |
| EG001 | 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. | 14 | 376 | 144 | 376 |
| EG002 | All Participants; 1200 mg GEn | 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. | 21 | 573 | 258 | 573 |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Meningitis Viral | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nerve Root Compression | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Angina Unstable | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Drug Withdrawal Syndrome | General disorders | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Non-Small Cell Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Postoperative Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Restless Legs Syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
|
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.
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |
|
| Week 4, n=171, 354, 525 |
|
| Week 12, n=150, 324, 474 |
|
| Week 24, n=138, 305, 443 |
|
| Week 36, n=132, 281, 413 |
|
| Week 52, n=126, 262, 388 |
|
|
| Week 4, n=174, 352, 526 |
|
| Week 12, n=150, 322, 472 |
|
| Week 24, n=139, 305, 444 |
|
| Week 36, n=130, 281, 411 |
|
|
| Week 0, Minimally improved, n=197, 376, 573 |
|
| Week 0, No change, n=197, 376, 573 |
|
| Week 0, Minimally worse, n=197, 376, 573 |
|
| Week 0, Much worse, n=197, 376, 573 |
|
| Week 0, Very much worse, n=197, 376, 573 |
|
| Week 1, Very much improved, n=185, 363, 548 |
|
| Week 1, Much improved, n=185, 363, 548 |
|
| Week 1, Minimally improved, n=185, 363, 548 |
|
| Week 1, No change, n=185, 363, 548 |
|
| Week 1, Minimally worse, n=185, 363, 548 |
|
| Week 1, Much worse, n=185, 363, 548 |
|
| Week 1, Very much worse, n=185, 363, 548 |
|
| Week 52, Very much improved, n=126, 262, 388 |
|
| Week 52, Much improved, n=126, 262, 388 |
|
| Week 52, Minimally improved, n=126, 262, 388 |
|
| Week 52, No change, n=126, 262, 388 |
|
| Week 52, Minimally worse, n=126, 262, 388 |
|
| Week 52, Much worse, n=126, 262, 388 |
|
| Week 52, Very much worse, n=126, 262, 388 |
|
|
| Week 4, n=171, 348, 519 |
|
| Week 12, n=148, 318, 466 |
|
| Week 24, n=133, 300, 433 |
|
| Week 36, n=129, 276, 405 |
|
| Week 52, n=122, 247, 369 |
|
|
| Week 0, Minimally improved, =197, 376, 573 |
|
| Week 0, No change, n=197, 376, 573 |
|
| Week 0, Minimally worse, n=197, 376, 573 |
|
| Week 0, Much worse, n=197, 376, 573 |
|
| Week 0, Very much worse, n=197, 376, 573 |
|
| Week 1, Very much improved, n=182, 351, 533 |
|
| Week 1, Much improved, n=182, 351, 533 |
|
| Week 1, Minimally improved, n=182, 351, 533 |
|
| Week 1, No change, n=182, 351, 533 |
|
| Week 1, Minimally worse, n=182, 351, 533 |
|
| Week 1, Much worse, n=182, 351, 533 |
|
| Week 1, Very much worse, n=182, 351, 533 |
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| Week 52, Very much improved, n=122, 247, 369 |
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| Week 52, Much improved, n=122, 247, 369 |
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| Week 52, Minimally improved, n=122, 247, 369 |
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| Week 52, No change, n=122, 247, 369 |
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| Week 52, Minimally worse, n=122, 247, 369 |
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| Week 52, Much worse, n=122, 247, 369 |
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| Week 52, Very much worse, n=122, 247, 369 |
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| 4 PM to 8 PM, n=122, 240, 362 |
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| 6 PM to 10 PM, n=122, 241, 363 |
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| 8 PM to 12 AM, n=122, 241, 363 |
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| 12 AM to 4 AM, n=123, 241, 364 |
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| 4 AM to 8 AM, n=123, 241, 364 |
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| Week 24, Overall Work Impairment, n=101, 185, 286 |
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| Week 24, Daily Activity Impairment, n=158,309,467 |
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| Week 52, Work Time Missed, n=82, 175, 257 |
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| Week 52, Impairment While Working n=78, 170, 248 |
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| Week 52, Overall Work Impairment, n=78, 170, 248 |
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| Week 52, Daily Activity Impairment, n=117,261,378 |
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| HW24, hr actually worked, n=108, 199, 307 |
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| W52, hr missed due to RLS, n=82, 175, 257 |
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| W52, hr missed other reason, n=82, 175, 257 |
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| W52, hr actually worked, n=82, 175, 257 |
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