Page last updated: 2024-10-16

carbamates and Dizziness

carbamates has been researched along with Dizziness in 10 studies

Dizziness: An imprecise term which may refer to a sense of spatial disorientation, motion of the environment, or lightheadedness.

Research Excerpts

ExcerptRelevanceReference
" The slopes of the exposure-response relationship for probability of dizziness and abnormal coordination were similar to that for efficacy, whereas the slopes for dysarthria, somnolence, tremor, and blurred vision were shallower, indicating that the probability of these events occurring was less affected than the probability of efficacy by increases in retigabine/ezogabine AUC0-τ."5.17Efficacy and tolerability exposure-response relationship of retigabine (ezogabine) immediate-release tablets in patients with partial-onset seizures. ( Berry, NS; Crean, CS; Reeve, R; Tompson, DJ, 2013)
" Pharmacodynamic measures were limited to subject assessment of somnolence, dizziness, and nausea conducted by using a visual analog scale (VAS)."2.80Gabapentin enacarbil and morphine administered in combination versus alone: a double-blind, randomized, pharmacokinetic, and tolerability comparison. ( Arumugham, T; Chen, C; Davy, M; Stier, B; Upward, J, 2015)
" Treatments were generally tolerated, with no serious adverse events or discontinuations owing to adverse events."2.78The effects of ethanol on the pharmacokinetics, pharmacodynamics, safety, and tolerability of ezogabine (retigabine). ( Crean, CS; Tompson, DJ, 2013)
" XP13512 immediate-release (up to 2800 mg single dose and 2100 mg twice daily) was well absorbed (>68%, based on urinary recovery of gabapentin), converted rapidly to gabapentin, and provided dose-proportional exposure, whereas absorption of oral gabapentin declined with increasing doses to <27% at 1200 mg."2.73Clinical pharmacokinetics of XP13512, a novel transported prodrug of gabapentin. ( Canafax, DM; Cundy, KC; Luo, W; Moors, TL; Sastry, S; Zou, J, 2008)
" We calculated the risk ratio (RR) of ≥50%, ≥75% and 100% reduction in seizure frequency from baseline, as well as dropout and serious adverse events related to treatment."2.72Efficacy and safety of cenobamate in patients with uncontrolled focal seizures: A meta-analysis. ( Wang, C; Wang, J; Zhang, L, 2021)
"Few studies have investigated restless legs syndrome (RLS) treatment effects on individual International RLS Study Group Rating Scale (IRLS) items."2.53Effect of Gabapentin Enacarbil on Individual Items of the International Restless Legs Study Group Rating Scale and Post-sleep Questionnaire in Adults with Moderate-to-Severe Primary Restless Legs Syndrome: Pooled Analysis of 3 Randomized Trials. ( Ahmed, M; Hays, R; Jaros, MJ; Kim, R; Shang, G; Steven Poceta, J, 2016)

Research

Studies (10)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's2 (20.00)29.6817
2010's7 (70.00)24.3611
2020's1 (10.00)2.80

Authors

AuthorsStudies
Zhang, L1
Wang, J1
Wang, C1
Tompson, DJ2
Crean, CS2
Reeve, R1
Berry, NS1
Chen, C1
Upward, J1
Arumugham, T1
Stier, B1
Davy, M1
Ahmed, M1
Hays, R1
Steven Poceta, J1
Jaros, MJ1
Kim, R1
Shang, G1
Cundy, KC1
Sastry, S1
Luo, W1
Zou, J1
Moors, TL1
Canafax, DM2
Kushida, CA1
Becker, PM1
Ellenbogen, AL1
Barrett, RW2
Sperling, MR1
Greenspan, A1
Cramer, JA1
Kwan, P1
Kälviäinen, R1
Halford, JJ1
Schmitt, J1
Yuen, E1
Cook, T1
Haas, M1
Novak, G1
Lee, DO1
Ziman, RB1
Perkins, AT1
Poceta, JS1
Walters, AS1
Gil-Nagel, A1
Brodie, MJ1
Leroy, R1
Cyr, T1
Hall, S1
Castiglia, M1
Twomey, C1
VanLandingham, K1

Clinical Trials (6)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Double-Blind, 3-Part Crossover Study to Assess the Pharmacokinetics and Tolerability of Single Doses of Gabapentin Enacarbil and Morphine Administered Alone and in Combination in Healthy Subjects[NCT01476124]Phase 118 participants (Actual)Interventional2011-08-31Completed
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome.[NCT00298623]Phase 3222 participants (Actual)Interventional2006-03-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to Assess the Efficacy, Safety, and Pharmacokinetics of XP13512 (GSK1838262) in Patients With Restless Legs Syndrome[NCT01332305]Phase 2217 participants (Actual)Interventional2007-01-31Completed
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome.[NCT00365352]Phase 3325 participants (Actual)Interventional2006-08-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects With Partial Onset Seizures Followed by an Open-Label Extension Study.[NCT00425282]Phase 3566 participants (Actual)Interventional2006-11-30Completed
Epilepsy Phase III Trial[NCT00433667]Phase 3563 participants (Actual)Interventional2006-11-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Mean AUCss

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. (NCT01332305)
Timeframe: Weeks 4 and 12

,,,
Interventionng*hour/ml (Mean)
Week 4, n=0, 38, 33, 33, 35Week 12, n=0, 32, 30, 30, 30
GEn 1200 mg96.195.7
GEn 1800 mg141146
GEn 2400 mg176173
GEn 600 mg49.351.4

Mean Css, Max and Css, Min

"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." (NCT01332305)
Timeframe: Weeks 4 and 12

,,,
Interventionnanograms per milliliter (ng/ml) (Mean)
Css, max; Week 4, n=0, 39, 33, 33, 36Css, max; Week 12, n=0, 32, 30, 30, 31Css, min; Week 4, n=0, 39, 33, 33, 36Css, min; Week 12, n=0, 32, 30, 30, 31
GEn 1200 mg7.147.151.371.32
GEn 1800 mg11.412.01.631.60
GEn 2400 mg14.013.32.342.41
GEn 600 mg3.864.140.6900.600

Mean Tmax and T1/2

"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." (NCT01332305)
Timeframe: Weeks 4 and 12

,,,
Interventionhours (Mean)
Tmax; Week 4, n=0, 39, 33, 33, 36Tmax; Week 12, n=0, 32, 30, 30, 31T1/2; Week 4, n=0, 38, 33, 33, 35T1/2, Week 12, n=0, 32, 30, 30, 30
GEn 1200 mg8.578.726.676.63
GEn 1800 mg7.618.005.825.89
GEn 2400 mg8.018.136.056.09
GEn 600 mg8.766.965.826.27

"Number of Participants With a Score of Much Improved or Very Much Improved on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF"

"The investigator -rated Clinical Global Impression of Improvement (CGI-I) scale is an assessment designed to allow investigators to rate the change of a participant's disease severity over time based on a seven-point scale, with a score of 1 being very much improved, a score of 2 being much improved, a score of 3 being minimally improved, a score of 4 being no change, a score of 5 being minimally improved,a score of 6 being much worse, and a score of 7 being very much worse. Participants with a response of much improved or very much improved were classified as responders." (NCT00365352)
Timeframe: Week 12

Interventionparticipants (Number)
Placebo43
GEn (XP13512/GSK1838262) 1200 mg86

Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF)

The International Restless Legs Syndrome (IRLS) Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. (NCT00365352)
Timeframe: Baseline and Week 12

Interventionscores on a scale (Mean)
Placebo-9.8
GEn (XP13512/GSK1838262) 1200 mg-13.0

Change From Baseline in Sleep Adequacy, an Item on the MOS Sleep Scale, at Week 12 Using LOCF

"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep adequacy domain ranged from 1 to 100, with a high score indicating greater adequacy. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)." (NCT00365352)
Timeframe: Basline and Week 12

Interventionscores on a scale (Mean)
Placebo13.6
GEn (XP13512/GSK1838262) 600 mg29.1
GEn (XP13512/GSK1838262) 1200 mg27.7

Change From Baseline in Sleep Quantity, an Item on the MOS Sleep Scale, at Week 12 Using LOCF

"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep quantity domain were measured in time (number of hours of sleep each night). The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)." (NCT00365352)
Timeframe: Baseline and Week 12

Interventionhours (Mean)
Placebo0.3
GEn (XP13512/GSK1838262) 600 mg0.6
GEn (XP13512/GSK1838262) 1200 mg0.8

Change From Baseline in the Average Daily RLS Pain Score at the End of Treatment (Week 12) for Participants With Pain at Baseline or the End of Week 12 Using LOCF

The Daily RLS pain score was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined study visits. The change from baseline was calculated as the End of Treatment (Week 12) value minus the Baseline (Day 1) value. (NCT00365352)
Timeframe: Baseline and End of Treatment (Week 12)

Interventionscores on a scale (Mean)
Placebo-1.7
GEn (XP13512/GSK1838262) 600 mg-2.5
GEn (XP13512/GSK1838262) 1200 mg-2.6

Change From Baseline in the Average Daily RLS Pain Score to Week 12 for Participants With a Baseline Pain Score of at Least 4 Using LOCF

The Average Daily RLS pain was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined visits. The change from baseline was calculated as the End of Treatment (Week 12) value minus the Baseline (Day 1) value. (NCT00365352)
Timeframe: Baseline and Week 12

Interventionscores on a scale (Mean)
Placebo-2.3
GEn (XP13512/GSK1838262) 600 mg-3.5
GEn (XP13512/GSK1838262) 1200 mg-3.5

Change From Baseline in the Daytime Somnolence Score, an Item on the Medical Outcomes Study (MOS) Sleep Scale, at Week 12 Using LOCF

"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the daytime somnolence domain ranged from 1 to 100, with a high score indicating greater daytime somnolence. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)." (NCT00365352)
Timeframe: Baseline and Week 12

Interventionscores on a scale (Mean)
Placebo-9.7
GEn (XP13512/GSK1838262) 600 mg-9.8
GEn (XP13512/GSK1838262) 1200 mg-16.1

Change From Baseline in the Overall Life-Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 12 Using LOCF

The Restless Legs Syndrome Quality of Life (RLS-QoL) questionnaire is a disease-specific, participant-rated questionnaire that assesses the impact of RLS on daily life, emotional well-being, social life, and work life of the participants. The RLS-QoL Questionnaire is presented on a 0 (lowest possible score) to 100 (highest possible score) scale. It was completed at Day 1 and at the end of Weeks 4, 8, and 12 (or Early Termination). (NCT00365352)
Timeframe: Baseline and Week 12

Interventionscores on a scale (Mean)
Placebo14.5
GEn (XP13512/GSK1838262) 600 mg19.3
GEn (XP13512/GSK1838262) 1200 mg20.4

Change From Baseline in the Profile of Mood State (POMS) Scale at Week 12 Using LOCF

"The Profile of Mood States (POMS) Brief Form contains 30 adjectives; each participant is asked to rate the degree to which each adjective describes themselves based on how they felt during the past week including the date on which the adjective was rated. The possible ratings range from 0 (Not all all) to 4 (Extremely). The Total Mood Disturbance Score (range of 0 to 120) is obtained by summing the values of six domains. Higher scores indicate a more negative mood disturbance. The POMS was completed at Baseline (Day 1), and at the end of Weeks 4, 8, and 12 (or Early Termination)." (NCT00365352)
Timeframe: Baseline to End of Treatment (Week 12)

Interventionscores on a scale (Mean)
Placebo-7.3
GEn (XP13512/GSK1838262) 600 mg-10.9
GEn (XP13512/GSK1838262) 1200 mg-11.5

Change From Baseline in the Sleep Disturbance Score, an Item on the MOS Sleep Scale, at Week 12 Using LOCF

"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep disturbance domain ranged from 1 to 100, with a high score indicating greater impairment of sleep. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)." (NCT00365352)
Timeframe: Baseline and Week 12

Interventionscores on a scale (Mean)
Placebo-17.0
GEn (XP13512/GSK1838262) 600 mg-29.5
GEn (XP13512/GSK1838262) 1200 mg-30.7

Change From Baseline to the End of Treatment (Week 12) in the IRLS Rating Scale Total Score Using LOCF

The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. (NCT00365352)
Timeframe: Baseline (Day 1) and End of Treatment (Week 12)

Interventionscores on a scale (Mean)
Placebo-9.8
GEn (XP13512/GSK1838262) 600 mg-13.8

Change From Baseline to the End of Treatment in Average Daily Total Sleep Time (Hours) Using LOCF

Average daily total sleep time was derived from the Pittsburgh Sleep Diary (PghSD; an instrument with separate components to be completed [self-reported] at bedtime and waketime) as the mean of non-missing total sleep time over the 7 days before each visit, where total sleep time = [(wake up time - lights out time) - time to fall asleep - time awake during the night] in hours. The change was calculated as the end of treatment (Week 12) value minus the Baseline value. (NCT00365352)
Timeframe: Baseline to End of Treatment (Week 12)

Interventionhours (Mean)
Placebo0.6
GEn (XP13512/GSK1838262) 600 mg0.7
GEn (XP13512/GSK1838262) 1200 mg1.0

Change From Baseline to the End of Treatment in Average Daily Wake Time (Minutes) After Sleep Onset Using LOCF

Average daily wake time after sleep onset was derived from the Pittsburgh Sleep Diary (PghSD) as the mean of non-missing total hours awake during the night after falling asleep over the 7 days before each visit. The change was calculated as the end of treatment (Week 12) value minus the Baseline value. (NCT00365352)
Timeframe: Baseline to End of Treatment (Week 12)

Interventionminutes (Mean)
Placebo-12.5
GEn (XP13512/GSK1838262) 600 mg-16.4
GEn (XP13512/GSK1838262) 1200 mg-18.5

Change From Baseline to the End of Week 1 in the IRLS Rating Scale Total Score Using LOCF

The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. (NCT00365352)
Timeframe: Baseline and the End of Week 1

Interventionscores on a scale (Mean)
Placebo-6.0
GEn (XP13512/GSK1838262) 600 mg-9.8
GEn (XP13512/GSK1838262) 1200 mg-8.7

Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF

"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders." (NCT00365352)
Timeframe: Week 12

Interventionparticipants (Number)
Placebo43
GEn (XP13512/GSK1838262) 600 mg83

Number of Participants Who Had an Onset of Response to Treatment at the End of Week 1 Based Upon the IRLS Rating Scale Total Score and the Investigator-rated CGI-I Using LOCF

"The IRLS Rating scale is a measure of RLS disease severity. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. Response was defined by an IRLS Rating Scale total score at the end of Week 1 < 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of much improved or very much improved." (NCT00365352)
Timeframe: End of Week 1

Interventionparticipants (Number)
Placebo13
GEn (XP13512/GSK1838262) 600 mg36
GEn (XP13512/GSK1838262) 1200 mg40

Number of Participants Who Indicated on the Mood Assessment That Their Mood Was Much Improved or Very Much Improved at Week 12 (End of Treatment) Using LOCF

The Mood Assessment is a non-disease-specific question surveying global change in a participant's overall mood. Participants were asked to rate their overall change in mood since the start of the study by choosing a score in a range from 1 (Very Much Improved) to 7 (Very Much Worse). The assessment was completed at Day 1 and the ends of Weeks 4, 8, and 12 or (Early Termination). (NCT00365352)
Timeframe: Week 12

Interventionparticipants (Number)
Placebo19
GEn (XP13512/GSK1838262) 600 mg35
GEn (XP13512/GSK1838262) 1200 mg39

Number of Participants With a Rating of Excellent for the Overall Quality of Sleep in Past Week Measured by the Post-Sleep Questionnaire (PSQ) at the End of Treatment (Week 12) Using LOCF

"The Post-Sleep Questionnaire (PSQ) was designed to evaluate overall sleep quality, ability to function, and RLS symptoms' interference with sleep over the past week. Participants were asked to rate overall sleep quality (as either Excellent, Reasonable, or Poor), ability to function, number of nights with RLS symptoms, number of nights awakened by RLS symptoms, and the number of hours spent awake due to RLS symptoms over the past week." (NCT00365352)
Timeframe: End of Treatment (Week 12)

Interventionparticipants (Number)
Placebo14
GEn (XP13512/GSK1838262) 600 mg24
GEn (XP13512/GSK1838262) 1200 mg30

Number of Total Responders to Treatment Based on the Investigator-Rated CGI of Improvement at the End of One Week of Treatment

"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders." (NCT00365352)
Timeframe: End of Week 1

Interventionresponders (Number)
Placebo26
GEn (XP13512/GSK1838262) 600 mg54
GEn (XP13512/GSK1838262) 1200 mg59

The Time to Onset of the First Response to Treatment on the IRLS Rating Scale Total Score and the Investigator-rated CGI-I

The Response was defined by an IRLS Rating Scale total score at the end of Week 1 < 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of much improved or very much improved. The median time to onset is estimated using the product-limit estimation method. (NCT00365352)
Timeframe: Baseline (Day 1) to End of Treatment (Week 12)

Interventionweeks (Median)
PlaceboNA
GEn (XP13512/GSK1838262) 600 Milligrams(mg) Taken Orally4.1
GEn (XP13512/GSK1838262) 1200 mg Taken Orally Once a Day2.1

Time to Onset of the First RLS Symptom From the 24-hour RLS Record Obtained at the End of Treatment (Week 12)

The time to onset of the first RLS symptoms from the 24-hour RLS Record is defined as the length of time from the start of the 24-hour assessment period (8:00 AM) to the time when 50% of participants experienced their first symptom. (NCT00365352)
Timeframe: Week 12

Interventionhours (Median)
Placebo12.8
GEn (XP13512/GSK1838262) 600 mg13.5
GEn (XP13512/GSK1838262) 1200 mg13.8

Change From Baseline in the IRLS Rating Scale Total Score at Week 12 by Baseline RLS Rating Scale Total Score Category (Baseline RLS Severity) Using LOCF

The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. (NCT00365352)
Timeframe: Baseline (Day 1) and Week 12

,,
Interventionscores on a scale (Mean)
IRLS Total Score < 17.5IRLS Total Score 17.5 to < 22.5IRLS Total Score 22.5 to < 27.5IRLS Total Score >= 27.5
GEn (XP13512/GSK1838262) 1200 mg-7.9-8.8-15.5-19.6
GEn (XP13512/GSK1838262) 600 mg-8.9-11.9-15.1-18.2
Placebo-6.3-8.5-9.6-13.3

Mean Change in the IRLS Rating Scale Total Score From Baseline at Week 12 by RLS Treatment History Using LOCF

The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. (NCT00365352)
Timeframe: Baseline (Day 1) and Week 12

,,
Interventionscores on a scale (Mean)
No RLS Treatment HistoryTreatment terminatedTreatment within 1 month of study start
GEn (XP13512/GSK1838262) 1200 mg-12.5-17.1-12.1
GEn (XP13512/GSK1838262) 600 mg-13.7-12.4-14.6
Placebo-8.8-13.3-10.7

Number of Participants Classified as Investigator-rated CGI-I Scale Responders at Week 12 by RLS Treatment History Using LOCF

"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders." (NCT00365352)
Timeframe: Basline and Week 12

,,
Interventionparticipants (Number)
No RLS Treatment HistoryTreatment terminatedTreatment within 1 month of study start
GEn (XP13512/GSK1838262) 1200 mg571315
GEn (XP13512/GSK1838262) 600 mg54918
Placebo26511

Number of Participants Classified as Responders to Treatment Based on the Participant-Rated CGI of Improvement at Week 1 and Week 12 (End of Treatment)

"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders." (NCT00365352)
Timeframe: Week 1 and Week 12

,,
Interventionparticipants (Number)
Responders at the End of Treatment (Week 12)Responders at the End of One Week
GEn (XP13512/GSK1838262) 1200 mg8352
GEn (XP13512/GSK1838262) 600 mg9055
Placebo4620

Number of Participants Classified as Responders With at Least 30% and 50% Improvement in the Average Daily RLS Pain Score Using LOCF

"The Mean Daily RLS pain was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined visits A Responder is a participant with a score of much improved or very much improved on the investigator rated CGI I Scale at the end of treatment (Week 12 using LOCF)." (NCT00365352)
Timeframe: Week 12

,,
Interventionparticipants (Number)
> or equal to 30% response> or equal to 50% response
GEn (XP13512/GSK1838262) 1200 mg7666
GEn (XP13512/GSK1838262) 600 mg7562
Placebo4841

Number of Participants Experiencing No RLS Symptoms in Each of the Seven 4-hour Periods From the 24-hour RLS Record at Week 12 (End of Treatment)

RLS severity ratings were summarized in 6 non-overlapping 4-hour periods beginning at 8 AM. A 4-hour period from 6 PM to 10 PM was also prospectively included to reflect the time frame when the most participants would experience their first symptoms of the day. (NCT00365352)
Timeframe: Week 12

,,
Interventionparticipants (Number)
8 AM to 12 PM12 PM to 4 PM4 PM to 8 PM6 PM to 10 PM8 PM to 12 AM12 AM to 4 AM4 AM to 8 AM
GEn (XP13512/GSK1838262) 1200 mg74696155486772
GEn (XP13512/GSK1838262) 600 mg85746855497479
Placebo52514539273856

Reviews

2 reviews available for carbamates and Dizziness

ArticleYear
Efficacy and safety of cenobamate in patients with uncontrolled focal seizures: A meta-analysis.
    Acta neurologica Scandinavica, 2021, Volume: 144, Issue:1

    Topics: Anticonvulsants; Carbamates; Chlorophenols; Dizziness; Dose-Response Relationship, Drug; Drug Resist

2021
Effect of Gabapentin Enacarbil on Individual Items of the International Restless Legs Study Group Rating Scale and Post-sleep Questionnaire in Adults with Moderate-to-Severe Primary Restless Legs Syndrome: Pooled Analysis of 3 Randomized Trials.
    Clinical therapeutics, 2016, Volume: 38, Issue:7

    Topics: Carbamates; Dizziness; Double-Blind Method; Fatigue; gamma-Aminobutyric Acid; Humans; Randomized Con

2016
Effect of Gabapentin Enacarbil on Individual Items of the International Restless Legs Study Group Rating Scale and Post-sleep Questionnaire in Adults with Moderate-to-Severe Primary Restless Legs Syndrome: Pooled Analysis of 3 Randomized Trials.
    Clinical therapeutics, 2016, Volume: 38, Issue:7

    Topics: Carbamates; Dizziness; Double-Blind Method; Fatigue; gamma-Aminobutyric Acid; Humans; Randomized Con

2016
Effect of Gabapentin Enacarbil on Individual Items of the International Restless Legs Study Group Rating Scale and Post-sleep Questionnaire in Adults with Moderate-to-Severe Primary Restless Legs Syndrome: Pooled Analysis of 3 Randomized Trials.
    Clinical therapeutics, 2016, Volume: 38, Issue:7

    Topics: Carbamates; Dizziness; Double-Blind Method; Fatigue; gamma-Aminobutyric Acid; Humans; Randomized Con

2016
Effect of Gabapentin Enacarbil on Individual Items of the International Restless Legs Study Group Rating Scale and Post-sleep Questionnaire in Adults with Moderate-to-Severe Primary Restless Legs Syndrome: Pooled Analysis of 3 Randomized Trials.
    Clinical therapeutics, 2016, Volume: 38, Issue:7

    Topics: Carbamates; Dizziness; Double-Blind Method; Fatigue; gamma-Aminobutyric Acid; Humans; Randomized Con

2016
Effect of Gabapentin Enacarbil on Individual Items of the International Restless Legs Study Group Rating Scale and Post-sleep Questionnaire in Adults with Moderate-to-Severe Primary Restless Legs Syndrome: Pooled Analysis of 3 Randomized Trials.
    Clinical therapeutics, 2016, Volume: 38, Issue:7

    Topics: Carbamates; Dizziness; Double-Blind Method; Fatigue; gamma-Aminobutyric Acid; Humans; Randomized Con

2016
Effect of Gabapentin Enacarbil on Individual Items of the International Restless Legs Study Group Rating Scale and Post-sleep Questionnaire in Adults with Moderate-to-Severe Primary Restless Legs Syndrome: Pooled Analysis of 3 Randomized Trials.
    Clinical therapeutics, 2016, Volume: 38, Issue:7

    Topics: Carbamates; Dizziness; Double-Blind Method; Fatigue; gamma-Aminobutyric Acid; Humans; Randomized Con

2016
Effect of Gabapentin Enacarbil on Individual Items of the International Restless Legs Study Group Rating Scale and Post-sleep Questionnaire in Adults with Moderate-to-Severe Primary Restless Legs Syndrome: Pooled Analysis of 3 Randomized Trials.
    Clinical therapeutics, 2016, Volume: 38, Issue:7

    Topics: Carbamates; Dizziness; Double-Blind Method; Fatigue; gamma-Aminobutyric Acid; Humans; Randomized Con

2016
Effect of Gabapentin Enacarbil on Individual Items of the International Restless Legs Study Group Rating Scale and Post-sleep Questionnaire in Adults with Moderate-to-Severe Primary Restless Legs Syndrome: Pooled Analysis of 3 Randomized Trials.
    Clinical therapeutics, 2016, Volume: 38, Issue:7

    Topics: Carbamates; Dizziness; Double-Blind Method; Fatigue; gamma-Aminobutyric Acid; Humans; Randomized Con

2016
Effect of Gabapentin Enacarbil on Individual Items of the International Restless Legs Study Group Rating Scale and Post-sleep Questionnaire in Adults with Moderate-to-Severe Primary Restless Legs Syndrome: Pooled Analysis of 3 Randomized Trials.
    Clinical therapeutics, 2016, Volume: 38, Issue:7

    Topics: Carbamates; Dizziness; Double-Blind Method; Fatigue; gamma-Aminobutyric Acid; Humans; Randomized Con

2016

Trials

8 trials available for carbamates and Dizziness

ArticleYear
Efficacy and tolerability exposure-response relationship of retigabine (ezogabine) immediate-release tablets in patients with partial-onset seizures.
    Clinical therapeutics, 2013, Volume: 35, Issue:8

    Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Disorders of Excessive Somnolence; Dizziness;

2013
Gabapentin enacarbil and morphine administered in combination versus alone: a double-blind, randomized, pharmacokinetic, and tolerability comparison.
    Clinical therapeutics, 2015, Feb-01, Volume: 37, Issue:2

    Topics: Adult; Amines; Analgesics, Opioid; Carbamates; Cross-Over Studies; Cyclohexanecarboxylic Acids; Dizz

2015
Clinical pharmacokinetics of XP13512, a novel transported prodrug of gabapentin.
    Journal of clinical pharmacology, 2008, Volume: 48, Issue:12

    Topics: Adult; Aged; Amines; Area Under Curve; Biological Availability; Capsules; Carbamates; Cross-Over Stu

2008
Randomized, double-blind, placebo-controlled study of XP13512/GSK1838262 in patients with RLS.
    Neurology, 2009, Feb-03, Volume: 72, Issue:5

    Topics: Adult; Amines; Anti-Anxiety Agents; Carbamates; Central Nervous System; Cyclohexanecarboxylic Acids;

2009
Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials.
    Epilepsia, 2010, Volume: 51, Issue:3

    Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Dizziness; Dose-Response Relationship, Drug; D

2010
Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials.
    Epilepsia, 2010, Volume: 51, Issue:3

    Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Dizziness; Dose-Response Relationship, Drug; D

2010
Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials.
    Epilepsia, 2010, Volume: 51, Issue:3

    Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Dizziness; Dose-Response Relationship, Drug; D

2010
Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials.
    Epilepsia, 2010, Volume: 51, Issue:3

    Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Dizziness; Dose-Response Relationship, Drug; D

2010
A randomized, double-blind, placebo-controlled study to assess the efficacy and tolerability of gabapentin enacarbil in subjects with restless legs syndrome.
    Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2011, Jun-15, Volume: 7, Issue:3

    Topics: Analysis of Variance; Carbamates; Disorders of Excessive Somnolence; Dizziness; Dose-Response Relati

2011
Safety and efficacy of ezogabine (retigabine) in adults with refractory partial-onset seizures: Interim results from two ongoing open-label studies.
    Epilepsy research, 2012, Volume: 102, Issue:1-2

    Topics: Adult; Anticonvulsants; Carbamates; Dizziness; Drug Resistance; Epilepsies, Partial; Fatigue; Female

2012
The effects of ethanol on the pharmacokinetics, pharmacodynamics, safety, and tolerability of ezogabine (retigabine).
    Clinical therapeutics, 2013, Volume: 35, Issue:1

    Topics: Adult; Anticonvulsants; Area Under Curve; Attention; Carbamates; Cross-Over Studies; Dizziness; Doub

2013