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.
Excerpt | Relevance | Reference |
---|---|---|
" 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." | 5.17 | Efficacy 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)." | 2.80 | Gabapentin 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." | 2.78 | The 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." | 2.73 | Clinical 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." | 2.72 | Efficacy 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." | 2.53 | 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. ( Ahmed, M; Hays, R; Jaros, MJ; Kim, R; Shang, G; Steven Poceta, J, 2016) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 2 (20.00) | 29.6817 |
2010's | 7 (70.00) | 24.3611 |
2020's | 1 (10.00) | 2.80 |
Authors | Studies |
---|---|
Zhang, L | 1 |
Wang, J | 1 |
Wang, C | 1 |
Tompson, DJ | 2 |
Crean, CS | 2 |
Reeve, R | 1 |
Berry, NS | 1 |
Chen, C | 1 |
Upward, J | 1 |
Arumugham, T | 1 |
Stier, B | 1 |
Davy, M | 1 |
Ahmed, M | 1 |
Hays, R | 1 |
Steven Poceta, J | 1 |
Jaros, MJ | 1 |
Kim, R | 1 |
Shang, G | 1 |
Cundy, KC | 1 |
Sastry, S | 1 |
Luo, W | 1 |
Zou, J | 1 |
Moors, TL | 1 |
Canafax, DM | 2 |
Kushida, CA | 1 |
Becker, PM | 1 |
Ellenbogen, AL | 1 |
Barrett, RW | 2 |
Sperling, MR | 1 |
Greenspan, A | 1 |
Cramer, JA | 1 |
Kwan, P | 1 |
Kälviäinen, R | 1 |
Halford, JJ | 1 |
Schmitt, J | 1 |
Yuen, E | 1 |
Cook, T | 1 |
Haas, M | 1 |
Novak, G | 1 |
Lee, DO | 1 |
Ziman, RB | 1 |
Perkins, AT | 1 |
Poceta, JS | 1 |
Walters, AS | 1 |
Gil-Nagel, A | 1 |
Brodie, MJ | 1 |
Leroy, R | 1 |
Cyr, T | 1 |
Hall, S | 1 |
Castiglia, M | 1 |
Twomey, C | 1 |
VanLandingham, K | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
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 1 | 18 participants (Actual) | Interventional | 2011-08-31 | Completed | ||
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome.[NCT00298623] | Phase 3 | 222 participants (Actual) | Interventional | 2006-03-31 | Completed | ||
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 2 | 217 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome.[NCT00365352] | Phase 3 | 325 participants (Actual) | Interventional | 2006-08-31 | Completed | ||
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 3 | 566 participants (Actual) | Interventional | 2006-11-30 | Completed | ||
Epilepsy Phase III Trial[NCT00433667] | Phase 3 | 563 participants (Actual) | Interventional | 2006-11-30 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
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
Intervention | ng*hour/ml (Mean) | |
---|---|---|
Week 4, n=0, 38, 33, 33, 35 | Week 12, n=0, 32, 30, 30, 30 | |
GEn 1200 mg | 96.1 | 95.7 |
GEn 1800 mg | 141 | 146 |
GEn 2400 mg | 176 | 173 |
GEn 600 mg | 49.3 | 51.4 |
"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
Intervention | nanograms per milliliter (ng/ml) (Mean) | |||
---|---|---|---|---|
Css, max; Week 4, n=0, 39, 33, 33, 36 | Css, max; Week 12, n=0, 32, 30, 30, 31 | Css, min; Week 4, n=0, 39, 33, 33, 36 | Css, min; Week 12, n=0, 32, 30, 30, 31 | |
GEn 1200 mg | 7.14 | 7.15 | 1.37 | 1.32 |
GEn 1800 mg | 11.4 | 12.0 | 1.63 | 1.60 |
GEn 2400 mg | 14.0 | 13.3 | 2.34 | 2.41 |
GEn 600 mg | 3.86 | 4.14 | 0.690 | 0.600 |
"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
Intervention | hours (Mean) | |||
---|---|---|---|---|
Tmax; Week 4, n=0, 39, 33, 33, 36 | Tmax; Week 12, n=0, 32, 30, 30, 31 | T1/2; Week 4, n=0, 38, 33, 33, 35 | T1/2, Week 12, n=0, 32, 30, 30, 30 | |
GEn 1200 mg | 8.57 | 8.72 | 6.67 | 6.63 |
GEn 1800 mg | 7.61 | 8.00 | 5.82 | 5.89 |
GEn 2400 mg | 8.01 | 8.13 | 6.05 | 6.09 |
GEn 600 mg | 8.76 | 6.96 | 5.82 | 6.27 |
"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
Intervention | participants (Number) |
---|---|
Placebo | 43 |
GEn (XP13512/GSK1838262) 1200 mg | 86 |
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
Intervention | scores on a scale (Mean) |
---|---|
Placebo | -9.8 |
GEn (XP13512/GSK1838262) 1200 mg | -13.0 |
"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
Intervention | scores on a scale (Mean) |
---|---|
Placebo | 13.6 |
GEn (XP13512/GSK1838262) 600 mg | 29.1 |
GEn (XP13512/GSK1838262) 1200 mg | 27.7 |
"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
Intervention | hours (Mean) |
---|---|
Placebo | 0.3 |
GEn (XP13512/GSK1838262) 600 mg | 0.6 |
GEn (XP13512/GSK1838262) 1200 mg | 0.8 |
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)
Intervention | scores on a scale (Mean) |
---|---|
Placebo | -1.7 |
GEn (XP13512/GSK1838262) 600 mg | -2.5 |
GEn (XP13512/GSK1838262) 1200 mg | -2.6 |
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
Intervention | scores on a scale (Mean) |
---|---|
Placebo | -2.3 |
GEn (XP13512/GSK1838262) 600 mg | -3.5 |
GEn (XP13512/GSK1838262) 1200 mg | -3.5 |
"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
Intervention | scores on a scale (Mean) |
---|---|
Placebo | -9.7 |
GEn (XP13512/GSK1838262) 600 mg | -9.8 |
GEn (XP13512/GSK1838262) 1200 mg | -16.1 |
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
Intervention | scores on a scale (Mean) |
---|---|
Placebo | 14.5 |
GEn (XP13512/GSK1838262) 600 mg | 19.3 |
GEn (XP13512/GSK1838262) 1200 mg | 20.4 |
"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)
Intervention | scores on a scale (Mean) |
---|---|
Placebo | -7.3 |
GEn (XP13512/GSK1838262) 600 mg | -10.9 |
GEn (XP13512/GSK1838262) 1200 mg | -11.5 |
"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
Intervention | scores on a scale (Mean) |
---|---|
Placebo | -17.0 |
GEn (XP13512/GSK1838262) 600 mg | -29.5 |
GEn (XP13512/GSK1838262) 1200 mg | -30.7 |
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)
Intervention | scores on a scale (Mean) |
---|---|
Placebo | -9.8 |
GEn (XP13512/GSK1838262) 600 mg | -13.8 |
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)
Intervention | hours (Mean) |
---|---|
Placebo | 0.6 |
GEn (XP13512/GSK1838262) 600 mg | 0.7 |
GEn (XP13512/GSK1838262) 1200 mg | 1.0 |
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)
Intervention | minutes (Mean) |
---|---|
Placebo | -12.5 |
GEn (XP13512/GSK1838262) 600 mg | -16.4 |
GEn (XP13512/GSK1838262) 1200 mg | -18.5 |
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
Intervention | scores on a scale (Mean) |
---|---|
Placebo | -6.0 |
GEn (XP13512/GSK1838262) 600 mg | -9.8 |
GEn (XP13512/GSK1838262) 1200 mg | -8.7 |
"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
Intervention | participants (Number) |
---|---|
Placebo | 43 |
GEn (XP13512/GSK1838262) 600 mg | 83 |
"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
Intervention | participants (Number) |
---|---|
Placebo | 13 |
GEn (XP13512/GSK1838262) 600 mg | 36 |
GEn (XP13512/GSK1838262) 1200 mg | 40 |
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
Intervention | participants (Number) |
---|---|
Placebo | 19 |
GEn (XP13512/GSK1838262) 600 mg | 35 |
GEn (XP13512/GSK1838262) 1200 mg | 39 |
"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)
Intervention | participants (Number) |
---|---|
Placebo | 14 |
GEn (XP13512/GSK1838262) 600 mg | 24 |
GEn (XP13512/GSK1838262) 1200 mg | 30 |
"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
Intervention | responders (Number) |
---|---|
Placebo | 26 |
GEn (XP13512/GSK1838262) 600 mg | 54 |
GEn (XP13512/GSK1838262) 1200 mg | 59 |
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)
Intervention | weeks (Median) |
---|---|
Placebo | NA |
GEn (XP13512/GSK1838262) 600 Milligrams(mg) Taken Orally | 4.1 |
GEn (XP13512/GSK1838262) 1200 mg Taken Orally Once a Day | 2.1 |
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
Intervention | hours (Median) |
---|---|
Placebo | 12.8 |
GEn (XP13512/GSK1838262) 600 mg | 13.5 |
GEn (XP13512/GSK1838262) 1200 mg | 13.8 |
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
Intervention | scores on a scale (Mean) | |||
---|---|---|---|---|
IRLS Total Score < 17.5 | IRLS Total Score 17.5 to < 22.5 | IRLS Total Score 22.5 to < 27.5 | IRLS 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 |
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
Intervention | scores on a scale (Mean) | ||
---|---|---|---|
No RLS Treatment History | Treatment terminated | Treatment 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 |
"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
Intervention | participants (Number) | ||
---|---|---|---|
No RLS Treatment History | Treatment terminated | Treatment within 1 month of study start | |
GEn (XP13512/GSK1838262) 1200 mg | 57 | 13 | 15 |
GEn (XP13512/GSK1838262) 600 mg | 54 | 9 | 18 |
Placebo | 26 | 5 | 11 |
"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
Intervention | participants (Number) | |
---|---|---|
Responders at the End of Treatment (Week 12) | Responders at the End of One Week | |
GEn (XP13512/GSK1838262) 1200 mg | 83 | 52 |
GEn (XP13512/GSK1838262) 600 mg | 90 | 55 |
Placebo | 46 | 20 |
"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
Intervention | participants (Number) | |
---|---|---|
> or equal to 30% response | > or equal to 50% response | |
GEn (XP13512/GSK1838262) 1200 mg | 76 | 66 |
GEn (XP13512/GSK1838262) 600 mg | 75 | 62 |
Placebo | 48 | 41 |
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
Intervention | participants (Number) | ||||||
---|---|---|---|---|---|---|---|
8 AM to 12 PM | 12 PM to 4 PM | 4 PM to 8 PM | 6 PM to 10 PM | 8 PM to 12 AM | 12 AM to 4 AM | 4 AM to 8 AM | |
GEn (XP13512/GSK1838262) 1200 mg | 74 | 69 | 61 | 55 | 48 | 67 | 72 |
GEn (XP13512/GSK1838262) 600 mg | 85 | 74 | 68 | 55 | 49 | 74 | 79 |
Placebo | 52 | 51 | 45 | 39 | 27 | 38 | 56 |
2 reviews available for carbamates and Dizziness
8 trials available for carbamates and Dizziness
Article | Year |
---|---|
Efficacy and tolerability exposure-response relationship of retigabine (ezogabine) immediate-release tablets in patients with partial-onset seizures.
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.
Topics: Adult; Amines; Analgesics, Opioid; Carbamates; Cross-Over Studies; Cyclohexanecarboxylic Acids; Dizz | 2015 |
Clinical pharmacokinetics of XP13512, a novel transported prodrug of gabapentin.
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.
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.
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.
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.
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.
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.
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.
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).
Topics: Adult; Anticonvulsants; Area Under Curve; Attention; Carbamates; Cross-Over Studies; Dizziness; Doub | 2013 |