carbamates and Sleepiness studies

Research Excerpts

Excerpt	Relevance	Reference
" Common treatment-emergent adverse events (TEAEs) with solriamfetol were headache, nausea, nasopharyngitis, insomnia, dry mouth, anxiety, decreased appetite, and upper respiratory tract infection; 27 (4."	2.94	Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea. ( Ahmed, M; Baladi, M; Chandler, P; Foldvary-Schaefer, N; Hedner, J; Lee, L; Malhotra, A; Mayer, G; Pepin, JL; Sarmiento, K; Schwab, R; Shapiro, C; Strollo, PJ, 2020)
"Excessive sleepiness (ES) is a common symptom of OSA, which often persists despite primary OSA therapy."	2.90	Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study. ( Black, J; Carter, LP; Chen, D; Collop, N; Hedner, J; Lee, L; Lorch, DG; Lu, Y; Pépin, JL; Redline, S; Strollo, PJ, 2019)
" The proportion of patients with at least one adverse event was significantly increased in solriamfetol group (RR = 1."	2.72	Efficacy and safety of solriamfetol for excessive sleepiness in narcolepsy and obstructive sleep apnea: findings from randomized controlled trials. ( Chen, G; Gao, H; Li, X; Wang, J; Wang, T; Xu, X; Xu, Z; Yang, S, 2021)

Research

Studies (6)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

Change in Epworth Sleepiness Scale (ESS) Score

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	3 (50.00)	24.3611
2020's	3 (50.00)	2.80

Authors	Studies
Malhotra, A	1
Shapiro, C	2
Pepin, JL	2
Hedner, J	2
Ahmed, M	1
Foldvary-Schaefer, N	1
Strollo, PJ	2
Mayer, G	2
Sarmiento, K	1
Baladi, M	1
Chandler, P	1
Lee, L	2
Schwab, R	1
Powell, J	1
Piszczatoski, C	1
Garland, S	1
Wang, J	1
Yang, S	1
Li, X	1
Wang, T	1
Xu, Z	1
Xu, X	1
Gao, H	1
Chen, G	1
Collop, N	1
Lorch, DG	1
Chen, D	2
Carter, LP	2
Lu, Y	2
Black, J	2
Redline, S	1
Thorpy, MJ	1
Corser, BC	1
Emsellem, H	1
Plazzi, G	1
Wang, H	1
Dauvilliers, Y	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea[NCT02348632]	Phase 3	645 participants (Actual)	Interventional	2015-05-31	Completed
A Double-Blind, Randomized, Placebo-Controlled, Single-Center, Flexible Titration Study Evaluating the Efficacy of Solriamfetol in Treating Fatigue and Cognitive Symptoms in Adults Aged 18-65 Years With a Diagnosis of Myalgic Encephalomyelitis/Chronic Fat[NCT04622293]	Phase 4	44 participants (Anticipated)	Interventional	2021-04-27	Recruiting
A Six-Week, Double-Blind, Placebo-Controlled, Randomized- Withdrawal, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep A[NCT02348619]	Phase 3	174 participants (Actual)	Interventional	2015-05-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

"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)

Intervention	points on a scale (Least Squares Mean)
JZP-110	1.6
Placebo	5.3

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)

Intervention	percentage of subjects (Number)
JZP-110	28.7
Placebo	63.8

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 Functional Outcomes of Sleep Questionnaire (FOSQ-10)

Intervention	percentage of subjects (Number)
JZP-110	28.2
Placebo	64.5

Change is total score from the end of the stable dose phase to the end of the double blind withdrawal phase. Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10) is a 10-item disease-specific quality of life questionnaire to assess the effect of excessiveness sleepiness on multiple activities of everyday living. The FOSQ-10 consists of 10 questions, each scored on a scale from 1-4. The questionnaire has a 4-point response format for each question (1 = extreme difficulty, 2 = moderate difficulty, 3 = a little difficulty, and 4 = no difficulty). The total score is derived by the mean of the 5 subscale scores, multiplied by 5, resulting in a possible range of scores between 5 to 20; lower FOSQ-10 scores are worse, indicating more difficulty carrying out activities; higher FOSQ-10 scores are better, indicating less difficulty carrying out activities. (NCT02348619)
Timeframe: Week 4 to Week 6

Change in the Epworth Sleepiness Scale (ESS)

Intervention	units on a scale (Least Squares Mean)
JZP-110	-0.15
Placebo	-1.31

"Change in Epworth Sleepiness Scale (ESS) score from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. 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 week 4 to week 6." (NCT02348619)
Timeframe: Week 4 to Week 6

Change in the Maintenance of Wakefulness Test (MWT)

Intervention	points on a scale (Least Squares Mean)
JZP-110	-0.1
Placebo	4.5

Change in the mean sleep latency time as determined from the first four trials of a 40-minute MWT from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. Mean sleep latency defined as the average of the first four MWT trial's measurements. (NCT02348619)
Timeframe: Week 4 to Week 6

Clinical Global Impression of Change (CGIc)

Intervention	minutes (Least Squares Mean)
JZP-110	-0.96
Placebo	-12.11

Percentage of subjects reported as worse (minimally, much, or very much) on the CGIc at the end of the Double-blind Withdrawal Phase. 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. (NCT02348619)
Timeframe: Week 4 to Week 6

Patient Global Impression of Change (PGIc)

Intervention	percentage of subjects (Number)
JZP-110	22
Placebo	59

Percentage of subjects reported as worse (minimally, much, or very much) on the PGIc at the end of the Double-blind Withdrawal Phase. 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. (NCT02348619)
Timeframe: Week 4 to Week 6

Article	Year
Solriamfetol (Sunosi) for excessive daytime sleepiness. The Medical letter on drugs and therapeutics, 2019, Aug-26, Volume: 61, Issue:1579 Topics: Adrenergic Uptake Inhibitors; Carbamates; Dopamine Uptake Inhibitors; Humans; Phenylalanine; Randomi	2019
Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea. The Annals of pharmacotherapy, 2020, Volume: 54, Issue:10 Topics: Carbamates; Clinical Trials as Topic; Disorders of Excessive Somnolence; Humans; Narcolepsy; Phenyla	2020
Efficacy and safety of solriamfetol for excessive sleepiness in narcolepsy and obstructive sleep apnea: findings from randomized controlled trials. Sleep medicine, 2021, Volume: 79 Topics: Adult; Carbamates; Disorders of Excessive Somnolence; Humans; Narcolepsy; Phenylalanine; Randomized	2021

carbamates and Sleepiness