Trial Outcomes & Findings for Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder (NCT NCT04788953)
NCT ID: NCT04788953
Last Updated: 2025-09-24
Results Overview
Sleep latency was assessed with a Maintenance Wakefulness Test (MWT) at Visit 2 (Baseline) and again at Visit 5 (End-of-Treatment). The MWT started \~2 hours after participant's usual wake time and consisted of four 40-minute trials (2, 4, 6, and 8 hours after usual wake time). Participants were fitted with polysomnography (PSG) and instructed to stay awake. Each trial was monitored and the trial was ended after PSG-sleep occurred or after 40 minutes if no sleep occurred. Sleep latency (in minutes) was calculated as the time between trial start time and sleep onset time. Change in mean sleep latency (i.e., averaged sleep latency across the four trials) from Visit 2 to Visit 5 was calculated for each participant.
TERMINATED
PHASE4
84 participants
Study Visit 2 (i.e., Baseline Visit) and Study Visit 5 (i.e., End-of-Treatment Visit after 4 weeks on solriamfetol or placebo)
2025-09-24
Participant Flow
Participants were recruited via online advertisements, radio advertisements and fliers between July 2021 and April 2024.
84 participants were enrolled in the study. Of these 84 participants, 6 were excluded before assigment (5 due to changes in participants' work schedules making them ineligible and 1 because the study was terminated/stopped study early). A total of 78 participants started taking solriamfetol or placebo.
Participant milestones
| Measure |
Solriamfetol (Sunosi)
Participants will start at 75 mg and take that dose for 3 consecutive days. Participants will take their first 75mg dose on an early morning work day and take the next two 75 mg doses upon awakening regardless of their work schedule. They will then move to 150mg on the next early morning work day and for all subsequent early morning shift work days. The drug/placebo will be taken orally within 30 minutes after awakening, before the start of each early morning shift. Prior to the end of study of visit (Visit 5), drug will be taken at home within 30 minutes of awakening.
Solriamfetol Oral Tablet: The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019
|
Control
Participants randomized into the Control arm will receive a placebo.
Placebo: Control subjects will receive placebo tablets for oral use.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
38
|
|
Overall Study
COMPLETED
|
38
|
36
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Solriamfetol (Sunosi)
Participants will start at 75 mg and take that dose for 3 consecutive days. Participants will take their first 75mg dose on an early morning work day and take the next two 75 mg doses upon awakening regardless of their work schedule. They will then move to 150mg on the next early morning work day and for all subsequent early morning shift work days. The drug/placebo will be taken orally within 30 minutes after awakening, before the start of each early morning shift. Prior to the end of study of visit (Visit 5), drug will be taken at home within 30 minutes of awakening.
Solriamfetol Oral Tablet: The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019
|
Control
Participants randomized into the Control arm will receive a placebo.
Placebo: Control subjects will receive placebo tablets for oral use.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder
Baseline characteristics by cohort
| Measure |
Solriamfetol (Sunosi)
n=38 Participants
Participants will start at 75 mg and take that dose for 3 consecutive days. Participants will take their first 75mg dose on an early morning work day and take the next two 75 mg doses upon awakening regardless of their work schedule. They will then move to 150mg on the next early morning work day and for all subsequent early morning shift work days. The drug/placebo will be taken orally within 30 minutes after awakening, before the start of each early morning shift. Prior to the end of study of visit (Visit 5), drug will be taken at home within 30 minutes of awakening.
Solriamfetol Oral Tablet: The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019
|
Control
n=36 Participants
Participants randomized into the Control arm will receive a placebo.
Placebo: Control subjects will receive placebo tablets for oral use.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
n=5 Participants
|
34 years
n=7 Participants
|
37 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27 kg/m2
n=5 Participants
|
29 kg/m2
n=7 Participants
|
28 kg/m2
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Visit 2 (i.e., Baseline Visit) and Study Visit 5 (i.e., End-of-Treatment Visit after 4 weeks on solriamfetol or placebo)Population: Data were analyzed for all participants who completed the study.
Sleep latency was assessed with a Maintenance Wakefulness Test (MWT) at Visit 2 (Baseline) and again at Visit 5 (End-of-Treatment). The MWT started \~2 hours after participant's usual wake time and consisted of four 40-minute trials (2, 4, 6, and 8 hours after usual wake time). Participants were fitted with polysomnography (PSG) and instructed to stay awake. Each trial was monitored and the trial was ended after PSG-sleep occurred or after 40 minutes if no sleep occurred. Sleep latency (in minutes) was calculated as the time between trial start time and sleep onset time. Change in mean sleep latency (i.e., averaged sleep latency across the four trials) from Visit 2 to Visit 5 was calculated for each participant.
Outcome measures
| Measure |
Solriamfetol (Sunosi)
n=38 Participants
Participants will start at 75 mg and take that dose for 3 consecutive days. Participants will take their first 75mg dose on an early morning work day and take the next two 75 mg doses upon awakening regardless of their work schedule. They will then move to 150mg on the next early morning work day and for all subsequent early morning shift work days. The drug/placebo will be taken orally within 30 minutes after awakening, before the start of each early morning shift. Prior to the end of study of visit (Visit 5), drug will be taken at home within 30 minutes of awakening.
Solriamfetol Oral Tablet: The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019
|
Control
n=36 Participants
Participants randomized into the Control arm will receive a placebo.
Placebo: Control subjects will receive placebo tablets for oral use.
|
|---|---|---|
|
Change in Mean Sleep Latency
|
12.6 minutes
Interval 10.0 to 15.2
|
3.2 minutes
Interval 0.6 to 5.8
|
SECONDARY outcome
Timeframe: Study Visit 2 (i.e., Baseline Visit) and Study Visit 5 (i.e., End-of-Treatment Visit after 4 weeks on solriamfetol or placebo)Population: Data were analyzed for all participants who completed the study.
Subjective sleepiness was assessed with a Karolinska Sleepiness Scale (KSS, Åkerstedt \& Gillberg, 1990). The KSS was administered to the participant \~5 minutes before the start of each four MWT trial at Visit 5 (Baseline) and again at Visit 5 (End-of-Treatment). The KSS scores range from 1 (very alert) to 9 (very sleepy), with higher scores indicating higher levels of sleepiness. Change in the mean KSS score (i.e., averaged score across the four trials) from Visit 2 to Visit 5 was calculated for each participant.
Outcome measures
| Measure |
Solriamfetol (Sunosi)
n=38 Participants
Participants will start at 75 mg and take that dose for 3 consecutive days. Participants will take their first 75mg dose on an early morning work day and take the next two 75 mg doses upon awakening regardless of their work schedule. They will then move to 150mg on the next early morning work day and for all subsequent early morning shift work days. The drug/placebo will be taken orally within 30 minutes after awakening, before the start of each early morning shift. Prior to the end of study of visit (Visit 5), drug will be taken at home within 30 minutes of awakening.
Solriamfetol Oral Tablet: The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019
|
Control
n=36 Participants
Participants randomized into the Control arm will receive a placebo.
Placebo: Control subjects will receive placebo tablets for oral use.
|
|---|---|---|
|
Change in Karolinska Sleepiness Scale Score
|
-1.7 score on a scale
Interval -2.0 to -1.3
|
-0.5 score on a scale
Interval -0.8 to -0.1
|
SECONDARY outcome
Timeframe: Study Visit 5 (i.e., End-of-Treatment Visit after 4 weeks on solriamfetol or placebo)Population: Data were analyzed for all participants who completed the study. CGI-C data for 2 patients in the Solriamfetol Group and 1 patient in the Placebo Group was lost due to technical error.
Overall change in participant's clinical condition was assessed with a Clinician's Global Impression of Change scale (CGI-Change, Guy, 1976). The CGI-change was conducted at Visit 5 (End-of-Treatment) by a study doctor who rated the participant. The scores range from 1 (very much improved) to 7 (very much worse), with lower scores indicating improved condition. Data were dichotomized such that scores 1-3 (very much improved, much improved, minimally improved) were considered to indicate improvement and scores 4-7 (no change, minimally worse, much worse, very much worse) were considered to indicate no improvement. Improvement was calculate as the percentage of participants in each group who reported improved scores.
Outcome measures
| Measure |
Solriamfetol (Sunosi)
n=36 Participants
Participants will start at 75 mg and take that dose for 3 consecutive days. Participants will take their first 75mg dose on an early morning work day and take the next two 75 mg doses upon awakening regardless of their work schedule. They will then move to 150mg on the next early morning work day and for all subsequent early morning shift work days. The drug/placebo will be taken orally within 30 minutes after awakening, before the start of each early morning shift. Prior to the end of study of visit (Visit 5), drug will be taken at home within 30 minutes of awakening.
Solriamfetol Oral Tablet: The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019
|
Control
n=35 Participants
Participants randomized into the Control arm will receive a placebo.
Placebo: Control subjects will receive placebo tablets for oral use.
|
|---|---|---|
|
Change in Clinician's Global Impression of Change Score
|
77.8 percent of improved participants
|
48.6 percent of improved participants
|
SECONDARY outcome
Timeframe: Study Visit 5 (i.e., End-of-Treatment Visit after 4 weeks on solriamfetol or placebo)Population: Data were analyzed for all participants who completed the study.
Participant's overall perception of change in their condition (i.e., excessive sleepiness) was assessed with a Patient's Global Impression of Change scale (PGI-Change, Guy, 1976). The PGI-C was administered to the participant at Visit 5 (End-of-Treatment). The scores ranged from 1 (no change or worse) to 7 (a great deal better), with higher scores indicating improved condition. Data were dichotomized such that scores 1-2 (no change or worse, hardly any change) were considered to indicate no improvement, and scores 3-7 (a little better, somewhat better, moderately better, better, a great deal better) were considered to indicate improvement.
Outcome measures
| Measure |
Solriamfetol (Sunosi)
n=38 Participants
Participants will start at 75 mg and take that dose for 3 consecutive days. Participants will take their first 75mg dose on an early morning work day and take the next two 75 mg doses upon awakening regardless of their work schedule. They will then move to 150mg on the next early morning work day and for all subsequent early morning shift work days. The drug/placebo will be taken orally within 30 minutes after awakening, before the start of each early morning shift. Prior to the end of study of visit (Visit 5), drug will be taken at home within 30 minutes of awakening.
Solriamfetol Oral Tablet: The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019
|
Control
n=36 Participants
Participants randomized into the Control arm will receive a placebo.
Placebo: Control subjects will receive placebo tablets for oral use.
|
|---|---|---|
|
Change in Patient's Global Impression of Change Score
|
78.9 percent of improved participants
|
47.2 percent of improved participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Study Visit 2 (i.e., Baseline Visit) and Study Visit 5 (i.e., End-of-Treatment Visit after 4 weeks on solriamfetol or placebo)Population: Data were analyzed for all participants who completed the study.
Work impairment was assessed with a Work Productivity and Activity Impairment-Specific Health Problem questionnaire (WPAI-SHP, Reilly et al., 1993; Emsellem et al., 2020), with excessive sleepiness as the specific health problem. The WPAI-SHP questionnaire was administered to the participant at Visit 2 (Baseline) and again at Visit 5 (End-of-Treatment). Overall work impairment score, which ranges from 0 to 100 with higher score indicating more impairment, was calculated from the WPAI-SHP subscales according to the WPAI scoring manual by Dr. Reilly. Change in the overall work impairment score from Visit 2 to Visit 5 was calculated for each participant.
Outcome measures
| Measure |
Solriamfetol (Sunosi)
n=38 Participants
Participants will start at 75 mg and take that dose for 3 consecutive days. Participants will take their first 75mg dose on an early morning work day and take the next two 75 mg doses upon awakening regardless of their work schedule. They will then move to 150mg on the next early morning work day and for all subsequent early morning shift work days. The drug/placebo will be taken orally within 30 minutes after awakening, before the start of each early morning shift. Prior to the end of study of visit (Visit 5), drug will be taken at home within 30 minutes of awakening.
Solriamfetol Oral Tablet: The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019
|
Control
n=36 Participants
Participants randomized into the Control arm will receive a placebo.
Placebo: Control subjects will receive placebo tablets for oral use.
|
|---|---|---|
|
Change in Overall Work Impairment Score From the Work Productivity and Activity Impairment Questionnaire
|
-21.6 overall work impairment score
Interval -31.5 to -11.7
|
-4.9 overall work impairment score
Interval -15.0 to 5.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Study Visit 2 (i.e., Baseline Visit) and Study Visit 5 (i.e., End-of-Treatment Visit after 4 weeks on solriamfetol or placebo)Population: Data were analyzed for all participants who completed the study.
Subjective global functioning was assessed with the short version of the Functional Outcomes of Sleep Questionnaire (FOSQ-10; Chasens et al., 2009). The FOSQ-10 was administered to the participant at Visit 2 (Baseline) and again at Visit 5 (End-of-Treatment). The FOSQ-10 consists of ten subscales with each subscale ranging from 1 (extreme difficulty) to 4 (no difficulty). The FOSQ-10 total score, which was calculated as the mean-weighted item score computed from the ten subscales, ranges from 5 to 20 with higher scores indicating less functional impairment. Change in FOSQ-10 total score from Visit 2 to Visit 5 was calculated for each participant.
Outcome measures
| Measure |
Solriamfetol (Sunosi)
n=38 Participants
Participants will start at 75 mg and take that dose for 3 consecutive days. Participants will take their first 75mg dose on an early morning work day and take the next two 75 mg doses upon awakening regardless of their work schedule. They will then move to 150mg on the next early morning work day and for all subsequent early morning shift work days. The drug/placebo will be taken orally within 30 minutes after awakening, before the start of each early morning shift. Prior to the end of study of visit (Visit 5), drug will be taken at home within 30 minutes of awakening.
Solriamfetol Oral Tablet: The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019
|
Control
n=36 Participants
Participants randomized into the Control arm will receive a placebo.
Placebo: Control subjects will receive placebo tablets for oral use.
|
|---|---|---|
|
Change in Functional Outcomes of Sleep Questionnaire Score
|
2.0 score on a scale
Interval 0.9 to 3.0
|
1.6 score on a scale
Interval 0.5 to 2.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Study Visit 2 (i.e., Baseline Visit) and Study Visit 5 (i.e., End-of-Treatment Visit after 4 weeks on solriamfetol or placebo)Population: Study Visit 2 (i.e., Baseline Visit) and Study Visit 5 (i.e., End-of-Treatment Visit after 4 weeks on solriamfetol or placebo)
The impact of excessive sleepiness on subjective global functioning was assessed with a Sheehan Disability Scale (SDS; Sheehan \& Sheehan, 2008). The questionnaire was administered to the participants at Visit 2 (Baseline) and again at Visit 5 (End-of-Treatment). The SDS consists of five subscales, with the scores for the three subscales (work, social, and family life) that are used for calculating the total score ranging from 0 (not at all impacted) to 10 (extremely impacted). The SDS total score, which was calculated as the sum of the three subscale scores, ranges from 0 to 30 with higher scores indicating greater functional impairment. Change in the SDS total score from Visit 2 to Visit 5 was calculated for each participant. which ranges from 0 to 30,
Outcome measures
| Measure |
Solriamfetol (Sunosi)
n=38 Participants
Participants will start at 75 mg and take that dose for 3 consecutive days. Participants will take their first 75mg dose on an early morning work day and take the next two 75 mg doses upon awakening regardless of their work schedule. They will then move to 150mg on the next early morning work day and for all subsequent early morning shift work days. The drug/placebo will be taken orally within 30 minutes after awakening, before the start of each early morning shift. Prior to the end of study of visit (Visit 5), drug will be taken at home within 30 minutes of awakening.
Solriamfetol Oral Tablet: The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019
|
Control
n=36 Participants
Participants randomized into the Control arm will receive a placebo.
Placebo: Control subjects will receive placebo tablets for oral use.
|
|---|---|---|
|
Change in Sheehan Disability Scale Score
|
-6.8 total score on a scale
Interval -9.3 to -4.4
|
-3.1 total score on a scale
Interval -5.6 to -0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Segment (2 weeks) and Treatment Segment (4 weeks)Population: Data were analyzed for all participants who completed the study over the 4 week treatment period. Actigraphy data for the last 2 weeks of treatment were missed for 1 patient in the Solriamfetol Group due to a damaged wrist activity monitor and for 1 patient in the Placebo Group due to technical failure.
Total Sleep Time (TST) was assessed with actigraphy. Participants wore a wrist activity monitor throughout the study (i.e., 2 weeks of baseline and 4 weeks of treatment). The actigraphy data from the main sleep periods were manually scored in 30-second epochs, and TST was calculated in minutes for each study day. Change in TST from baseline to treatment was calculated for each participant.
Outcome measures
| Measure |
Solriamfetol (Sunosi)
n=38 Participants
Participants will start at 75 mg and take that dose for 3 consecutive days. Participants will take their first 75mg dose on an early morning work day and take the next two 75 mg doses upon awakening regardless of their work schedule. They will then move to 150mg on the next early morning work day and for all subsequent early morning shift work days. The drug/placebo will be taken orally within 30 minutes after awakening, before the start of each early morning shift. Prior to the end of study of visit (Visit 5), drug will be taken at home within 30 minutes of awakening.
Solriamfetol Oral Tablet: The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019
|
Control
n=36 Participants
Participants randomized into the Control arm will receive a placebo.
Placebo: Control subjects will receive placebo tablets for oral use.
|
|---|---|---|
|
Change in Total Sleep Time
|
-3.6 minutes
Interval -13.5 to 6.3
|
-7.2 minutes
Interval -17.3 to 2.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline Segment (2 Weeks) and Treatment Segment (4 Weeks)Population: Data were analyzed for all participants who completed the study over the 4 week treatment period. Actigraphy data for the last 2 weeks of treatment were missed for 1 patient in the Solriamfetol Group due to a damaged wrist activity monitor and for 1 patient in the Placebo Group due to technical failure.
Sleep disturbances were assessed with actigraphy-derived fragmentation index. Participants wore a wrist activity monitor throughout the study (i.e., 2 weeks of baseline and 4 weeks of treatment). The actigraphy data from the main sleep periods were manually scored in 30-second epochs in the MotioWare software (CamNtech, Cambridge, UK). MotionWare defines the fragmentation index as the sum of the percentages of mobile time and immobile bouts immobile bouts below or equal to 1 minute during the sleep period, which is a unitless measure. Change in fragmentation index from baseline to treatment was calculated for each participant.
Outcome measures
| Measure |
Solriamfetol (Sunosi)
n=38 Participants
Participants will start at 75 mg and take that dose for 3 consecutive days. Participants will take their first 75mg dose on an early morning work day and take the next two 75 mg doses upon awakening regardless of their work schedule. They will then move to 150mg on the next early morning work day and for all subsequent early morning shift work days. The drug/placebo will be taken orally within 30 minutes after awakening, before the start of each early morning shift. Prior to the end of study of visit (Visit 5), drug will be taken at home within 30 minutes of awakening.
Solriamfetol Oral Tablet: The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019
|
Control
n=36 Participants
Participants randomized into the Control arm will receive a placebo.
Placebo: Control subjects will receive placebo tablets for oral use.
|
|---|---|---|
|
Change in Sleep Fragmentation Index
|
0.5 unitless measure
Interval -0.5 to 1.5
|
0.9 unitless measure
Interval -0.1 to 1.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Study Visit 2 (i.e., Baseline Visit) and Study Visit 5 (i.e., End of Treatment Visit after 4 weeks on solriamfetol or placebo)Population: Data were analyzed for all participants who completed the study.
Subjective sleepiness was assessed with a modified Epworth Sleepiness Scale (ESS, Johns, 1990, 1997). The ESS was administered to the participant at Visit 2 (Baseline) and again at Visit 5 (End-of-Treatment). The ESS consists of eight subscales with each subscale ranging from 0 (never doze) to 3 (high change to doze off). The ESS total score, which was calculated as the sum of the eight subscalescores, ranges from 0 (normal levels of sleepiness) to 24 (severe excessive sleepiness) with higher scores indcating higher levels of sleepiness. Change in the ESS total score from Visit 2 to Visit 5 was calculated for each participant. total score, which ranges from 0 to 24 (0=normal level of sleepiness, 24=severe excessive sleepiness), was calculated by summing the scores from the eight subscales. Change in ESS total score from Visit 2 to Visit 5 was calculated for each participant.
Outcome measures
| Measure |
Solriamfetol (Sunosi)
n=38 Participants
Participants will start at 75 mg and take that dose for 3 consecutive days. Participants will take their first 75mg dose on an early morning work day and take the next two 75 mg doses upon awakening regardless of their work schedule. They will then move to 150mg on the next early morning work day and for all subsequent early morning shift work days. The drug/placebo will be taken orally within 30 minutes after awakening, before the start of each early morning shift. Prior to the end of study of visit (Visit 5), drug will be taken at home within 30 minutes of awakening.
Solriamfetol Oral Tablet: The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019
|
Control
n=36 Participants
Participants randomized into the Control arm will receive a placebo.
Placebo: Control subjects will receive placebo tablets for oral use.
|
|---|---|---|
|
Change in Epworth Sleepiness Scale Score
|
-7.2 score on a scale
Interval -8.8 to -5.5
|
-2.4 score on a scale
Interval -4.1 to -0.8
|
Adverse Events
Control
Solriamfetol (Sunosi)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=38 participants at risk
Participants randomized into the Control arm will receive a placebo
Placebo: Control subjects will receive placebo tablets for oral use.
|
Solriamfetol (Sunosi)
n=40 participants at risk
Participants will start at 75 mg and take that dose for 3 consecutive days. Participants will take their first 75mg dose on an early morning work day and take the next two 75 mg doses upon awakening regardless of their work schedule.
They will then move to 150mg on the next early morning work day and for all subsequent early morning shift work days. The drug/placebo will be taken orally within 30 minutes after awakening, before the start of each early morning shift. Prior to the end of study of visit (Visit 5), drug will be taken at home within 30 minutes of awakening.
Solriamfetol Oral Tablet: The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019
|
|---|---|---|
|
General disorders
abnormal dreams
|
0.00%
0/38 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
7.5%
3/40 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
|
Psychiatric disorders
anxiety
|
0.00%
0/38 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
7.5%
3/40 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
|
Cardiac disorders
arrhythmias
|
5.3%
2/38 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
0.00%
0/40 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
5.3%
2/38 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
5.0%
2/40 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
|
Respiratory, thoracic and mediastinal disorders
covid-19
|
5.3%
2/38 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
2.5%
1/40 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
|
Metabolism and nutrition disorders
decreased appetite
|
0.00%
0/38 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
10.0%
4/40 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
|
Gastrointestinal disorders
diarrhea
|
2.6%
1/38 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
5.0%
2/40 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
|
Nervous system disorders
dizziness
|
5.3%
2/38 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
7.5%
3/40 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
|
General disorders
feeling jittery
|
5.3%
2/38 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
10.0%
4/40 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
|
Nervous system disorders
headache
|
26.3%
10/38 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
30.0%
12/40 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
|
Psychiatric disorders
insomnia
|
5.3%
2/38 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
2.5%
1/40 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
|
General disorders
lethargy
|
7.9%
3/38 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
2.5%
1/40 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
|
Respiratory, thoracic and mediastinal disorders
nasopharyngitis
|
5.3%
2/38 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
2.5%
1/40 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
|
Gastrointestinal disorders
nausea
|
13.2%
5/38 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
17.5%
7/40 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
|
Respiratory, thoracic and mediastinal disorders
sinusitis
|
5.3%
2/38 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
2.5%
1/40 • Adverse events data for each participant was collected for approximately 4 weeks. This spanned the time period between Visit 3 (solriamfetol/placebo dispensed to the participant) and Visit 5 (last solriamfetol/placebo dose).
Adverse events were collected from participant reports during study visits, scheduled check-ins, and other interactions with the participants. Adverse event reporting includes all adverse events that occurred between study visits 3 and 5 for participants who took at least one dose of drug/placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place