carbamates and Narcolepsy

carbamates has been researched along with Narcolepsy in 21 studies

Narcolepsy: A condition characterized by recurrent episodes of daytime somnolence and lapses in consciousness (microsomnias) that may be associated with automatic behaviors and AMNESIA. CATAPLEXY; SLEEP PARALYSIS, and hypnagogic HALLUCINATIONS frequently accompany narcolepsy. The pathophysiology of this disorder includes sleep-onset rapid eye movement (REM) sleep, which normally follows stage III or IV sleep. (From Neurology 1998 Feb;50(2 Suppl 1):S2-S7)

Research

Studies (21)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Change in Epworth Sleepiness Scale (ESS) Score

"Change in Epworth Sleepiness Scale (ESS) score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. A negative change from baseline represents improvement in excessive sleepiness.~The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. This analysis included treatment group and randomization stratification factor (narcolepsy vs. OSA) as fixed effects. The ESS score at the beginning of the randomized withdrawal period was used as the covariate. The response variable was the change in ESS score from the beginning to the end of 2- week randomized withdrawal period." (NCT02348632)
Timeframe: Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks)

Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc)

Subjects reported as worse (very much worse, much worse, and minimally worse) on the CGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. (NCT02348632)
Timeframe: Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)

Subjects Reported as Worse on the Patient Global Impression of Change (PGIc)

Percentage of subjects reported as worse (minimally worse, much worse, or very much worse) on the PGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. (NCT02348632)
Timeframe: Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)

Change in ESS Score From Baseline to Week 12

"Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness.~The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline." (NCT02348593)
Timeframe: Baseline to Week 12

Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12

Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing. (NCT02348593)
Timeframe: Baseline to Week 12

Change in Sleep Latency Time on MWT Trial 1 at Week 12

Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12. (NCT02348593)
Timeframe: Change from baseline for sleep latency in MWT during trial 1 at week 12

Change in Sleep Latency Time on MWT Trial 2 at Week 12

Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12. (NCT02348593)
Timeframe: Change from baseline for sleep latency in MWT during trial 2 at week 12

Change in Sleep Latency Time on MWT Trial 3 at Week 12

Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12. (NCT02348593)
Timeframe: Change from baseline for sleep latency in MWT during trial 3 at week 12

Change in Sleep Latency Time on MWT Trial 4 at Week 12

Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12. (NCT02348593)
Timeframe: Change from baseline for sleep latency in MWT during trial 4 at week 12

Change in Sleep Latency Time on MWT Trial 5 at Week 12

Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12. (NCT02348593)
Timeframe: Change from baseline for sleep latency in MWT during trial 5 at week 12

Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-Minute MWT From Baseline to Week 4

Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from Baseline to Week 4. (NCT02348593)
Timeframe: Baseline to Week 4

Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12

Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse (NCT02348593)
Timeframe: Baseline to Week 12

Change in ESS Score From Baseline to Week 12

"Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness.~The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline." (NCT02348606)
Timeframe: Baseline to Week 12

Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12

Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12. (NCT02348606)
Timeframe: Baseline to Week 12

Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4

Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to week 4. (NCT02348606)
Timeframe: Baseline to Week 4

Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12

Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 12. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse. (NCT02348606)
Timeframe: Week 12

Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12

"Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since start of treatment on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.~This is the key secondary endpoint." (NCT02348606)
Timeframe: 12 Weeks

Change in ESS Score From Baseline to Week 1, Week 4, and Week 8

"Change in Epworth Sleepiness Scale (ESS) score from Baseline to Weeks 1, 4, and 8. A negative change from baseline represents improvement in excessive sleepiness.~The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline." (NCT02348606)
Timeframe: Baseline to Weeks 1, 4, and 8

Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12

Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at week 12. (NCT02348606)
Timeframe: Baseline and Week 12

Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8

Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 1, Week 4, and Week 8. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse. (NCT02348606)
Timeframe: Weeks 1, 4, and 8

Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8

Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 1, Week 4, and Week 8. PGIc was rated by subjects and measures the change in their condition since treatment start on a 7-point scale ranging from 1 = very much improved to 7 = very much worse. (NCT02348606)
Timeframe: Weeks 1, 4, and 8

Change From Baseline in Epworth Sleepiness Scale (ESS) Scores for ADX-N05 vs. Placebo at Week 4

"The ESS is a questionnaire intended to measure daytime sleepiness. In this test, participants answer questions with regard to the level of sleepiness they experienced over approximately the 7 days prior to the assessment while performing eight common, non-stimulating activities. The ESS total score range is 1 to 24. Each activity is rated on a 4-point scale ranging from a minimum of would never doze to a maximum of a high chance of dozing. Thus, the ESS scale range is as follows: 0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing; 0 indicates a better outcome, and 3 indicates a worse outcome. A negative mean change value indicates a decrease in score from baseline and an improvement in daytime sleepiness." (NCT01681121)
Timeframe: Baseline up to Week 4 post-dose.

Change From Baseline in ESS Scores for ADX-N05 vs. Placebo at Last Assessment

"The ESS is a questionnaire intended to measure daytime sleepiness. In this test, participants answer questions with regard to the level of sleepiness they experienced over approximately the 7 days prior to the assessment while performing eight common, non-stimulating activities. The ESS total score range is 1 to 24. Each activity is rated on a 4-point scale ranging from a minimum of would never doze to a maximum of a high chance of dozing. Thus, the ESS scale range is as follows: 0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing; 0 indicates a better outcome, and 3 indicates a worse outcome. A negative mean change value indicates a decrease in score from baseline and an improvement in daytime sleepiness." (NCT01681121)
Timeframe: Baseline up to Week 12/Last Assessment post-dose.

Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) (Average of the First Four Trials) Following Four Weeks of Treatment With ADX-N05 150 mg vs. Placebo

"The MWT is a validated objective measure of the ability to stay awake for a defined period of time. The MWT consisted of five 40-minute trials separated by 2 hour intervals.~This secondary analysis repeated the primary analysis for effects at the end of Week 4." (NCT01681121)
Timeframe: Baseline up to Week 4 post-dose.

Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) for ADX-N05 300 mg vs. Placebo at Last Assessment.

The MWT is a validated objective measure of the ability to stay awake for a defined period of time. The primary analysis was a comparison of treatments vs. control groups on change from Baseline to last available post-Baseline assessment (Week 12/Last Assessment) in the average sleep latency time (in minutes) averaged across the first four trials of the MWT using a two-sample t-test. (NCT01681121)
Timeframe: Baseline up to Week 12/Last Assessment post-dose.

Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores for ADX-N05 vs. Placebo at Last Assessment

"The CGI-C scale rated the change in the participant's condition as compared to the Baseline visit on a 7-point scale ranging from a minimum of Very much improved to a maximum of Very much worse. The proportion of subjects experiencing at least minimal improvement on the CGI-C was calculated and summarized for each of the treatment groups at Week 4 and the last available post-Baseline assessment (Week 12/Last Assessment). The CGI-C scale consists of the following ratings: 1-Very Much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse; a rating of 1 indicates a better outcome, and a rating of 7 indicates a worse outcome. Improvement was defined as a CGI-rating of 1, 2, or 3." (NCT01681121)
Timeframe: Week 12

Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores for ADX-N05 vs. Placebo at Week 4

"The CGI-C scale rated the change in the participant's condition as compared to the Baseline visit on a 7-point scale ranging from a minimum of Very much improved to a maximum of Very much worse. The proportion of subjects experiencing at least minimal improvement on the CGI-C was calculated and summarized for each of the treatment groups at Week 4 and the last available post-Baseline assessment (Week 12/Last Assessment). The CGI-C scale consists of the following ratings: 1-Very Much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse; a rating of 1 indicates a better outcome, and a rating of 7 indicates a worse outcome. Improvement was defined as a CGI-rating of 1, 2, or 3." (NCT01681121)
Timeframe: Week 4

Number of Participants With Improved Patient Global Impression Change (PGI-C) Scores for ADX-N05 vs. Placebo at Week 4

"The Patient Global Impression - Change (PGI-C) scale was completed by the subject at the Weeks 1, 2, 4, 6, 8, and 12 visits. The CGI-C scale rated the change in the participant's condition as compared to the Baseline visit on a 7-point scale ranging from a minimum of Very much improved to a maximum of Very much worse. The proportion of subjects experiencing at least minimal improvement on the CGI-C was calculated and summarized for each of the treatment groups at Week 4 and the last available post-Baseline assessment (Week 12/Last Assessment). The CGI-C scale consists of the following ratings: 1-Very Much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse; a rating of 1 indicates a better outcome, and a rating of 7 indicates a worse outcome. Improvement was defined as a CGI-rating of 1, 2, or 3." (NCT01681121)
Timeframe: Week 4

Number of Participants With Improved PGI-C Scores for ADX-N05 vs. Placebo at Last Assessment

"The Patient Global Impression - Change (PGI-C) scale was completed by the subject at the Weeks 1, 2, 4, 6, 8, and 12 visits. The CGI-C scale rated the change in the participant's condition as compared to the Baseline visit on a 7-point scale ranging from a minimum of Very much improved to a maximum of Very much worse. The proportion of subjects experiencing at least minimal improvement on the CGI-C was calculated and summarized for each of the treatment groups at Week 4 and the last available post-Baseline assessment (Week 12/Last Assessment). The CGI-C scale consists of the following ratings: 1-Very Much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse; a rating of 1 indicates a better outcome, and a rating of 7 indicates a worse outcome. Improvement was defined as a CGI-rating of 1, 2, or 3." (NCT01681121)
Timeframe: Week 12/Last Assessment

Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual MWT Trials for ADX-N05 vs. Placebo at Last Assessment

"The MWT is a validated objective measure of the ability to stay awake for a defined period of time. The MWT consisted of five 40-minute trials separated by 2 hour intervals.~This secondary analysis repeated the primary analysis for effects for the five MWT trials analyzed separately at the last available post-Baseline assessment (Week 12/Last Assessment)." (NCT01681121)
Timeframe: Baseline up to Week 12/Last Assessment post-dose.

Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual MWT Trials for ADX-N05 vs. Placebo at Week 4

"The MWT is a validated objective measure of the ability to stay awake for a defined period of time. The MWT consisted of five 40-minute trials separated by 2 hour intervals.~This secondary analysis repeated the primary analysis for effects for the five MWT trials analyzed separately at Week 4." (NCT01681121)
Timeframe: Baseline up to Week 4 post-dose.

Reviews

7 reviews available for carbamates and Narcolepsy

Trials

11 trials available for carbamates and Narcolepsy

Other Studies

3 other studies available for carbamates and Narcolepsy