Trial Outcomes & Findings for A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness (NCT NCT01485770)
NCT ID: NCT01485770
Last Updated: 2021-07-06
Results Overview
The MWT is a validated objective measure of the ability to stay awake for a defined period of time. The change from baseline in the mean sleep latency from the MWT was the average of sleep latency from the four trials of the MWT.
COMPLETED
PHASE2
33 participants
Baseline up to 2 weeks post-dose.
2021-07-06
Participant Flow
Participant milestones
| Measure |
Placebo, Then ADX-N05
Participants first received a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 1 and 2). They then received ADX-N05 150 mg tablet once a day for seven days (Week 3) followed by 300 mg (2 tablets) once a day for seven days (Week 4).
|
ADX-N05, Then Placebo
Participants first received ADX-N05 150 mg tablet once a day for seven days (Week 1) followed by 300 mg (2 tablets) once a day for seven days (Week 2). They then received a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 3 and 4).
|
|---|---|---|
|
First Intervention (2 Weeks)
STARTED
|
17
|
16
|
|
First Intervention (2 Weeks)
COMPLETED
|
17
|
16
|
|
First Intervention (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (2 Weeks)
STARTED
|
17
|
16
|
|
Second Intervention (2 Weeks)
COMPLETED
|
17
|
16
|
|
Second Intervention (2 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
Baseline characteristics by cohort
| Measure |
Placebo, Then ADX-N05
n=17 Participants
Participants first received a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 1 and 2). They then received ADX-N05 150 mg tablet once a day for seven days (Week 3) followed by 300 mg (2 tablets) once a day for seven days (Week 4).
|
ADX-N05, Then Placebo
n=16 Participants
Participants first received ADX-N05 150 mg tablet once a day for seven days (Week 1) followed by 300 mg (2 tablets) once a day for seven days (Week 2). They then received a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 3 and 4).
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.71 years
STANDARD_DEVIATION 11.56 • n=5 Participants
|
42.81 years
STANDARD_DEVIATION 10.72 • n=7 Participants
|
37.1 years
STANDARD_DEVIATION 12.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 2 weeks post-dose.The MWT is a validated objective measure of the ability to stay awake for a defined period of time. The change from baseline in the mean sleep latency from the MWT was the average of sleep latency from the four trials of the MWT.
Outcome measures
| Measure |
ADX-N05 300 mg
n=33 Participants
Participants took 2 tablets of 150 mg (300 mg) ADX-N05 once a day during week 2 or week 4 of the 4-week study treatment period.
|
Placebo
n=33 Participants
Participants took Placebo to match ADX-N05 once a day during week 2 or week 4 of the 4-week study treatment period.
|
|---|---|---|
|
Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) Following Two Weeks of Treatment With ADX-N05 vs. Two Weeks of Treatment With Placebo
|
12.7 minutes
Standard Deviation 10.64
|
0.9 minutes
Standard Deviation 6.02
|
SECONDARY outcome
Timeframe: Baseline up to Week 3 post-dose.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.
Outcome measures
| Measure |
ADX-N05 300 mg
n=33 Participants
Participants took 2 tablets of 150 mg (300 mg) ADX-N05 once a day during week 2 or week 4 of the 4-week study treatment period.
|
Placebo
n=33 Participants
Participants took Placebo to match ADX-N05 once a day during week 2 or week 4 of the 4-week study treatment period.
|
|---|---|---|
|
Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 1 and 3
|
-5.3 score on a scale
Standard Deviation 5.20
|
-1.2 score on a scale
Standard Deviation 4.09
|
SECONDARY outcome
Timeframe: Baseline up to Week 4 post-dose.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.
Outcome measures
| Measure |
ADX-N05 300 mg
n=33 Participants
Participants took 2 tablets of 150 mg (300 mg) ADX-N05 once a day during week 2 or week 4 of the 4-week study treatment period.
|
Placebo
n=33 Participants
Participants took Placebo to match ADX-N05 once a day during week 2 or week 4 of the 4-week study treatment period.
|
|---|---|---|
|
Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 2 and 4
|
-6.7 score on a scale
Standard Deviation 6.15
|
-2.4 score on a scale
Standard Deviation 3.82
|
SECONDARY outcome
Timeframe: Week 1 and Week 3 post-dose.The CGI-C scale was completed at Week 1 through 4 visits. The participant was rated on a 7-point scale ranging from a minimum of "Very much improved" to a maximum of "Very much worse." The proportion of participants experiencing at least minimal improvement on the CGI-C was calculated and summarized for each of the two weeks of each of the treatment periods. 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.
Outcome measures
| Measure |
ADX-N05 300 mg
n=33 Participants
Participants took 2 tablets of 150 mg (300 mg) ADX-N05 once a day during week 2 or week 4 of the 4-week study treatment period.
|
Placebo
n=33 Participants
Participants took Placebo to match ADX-N05 once a day during week 2 or week 4 of the 4-week study treatment period.
|
|---|---|---|
|
Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 1 and 3
|
29 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 2 and Week 4 post-dose.The CGI-C scale was completed at Week 1 through 4 visits. The participant was rated on a 7-point scale ranging from a minimum of "Very much improved" to a maximum of "Very much worse." The proportion of participants experiencing at least minimal improvement on the CGI-C was calculated and summarized for each of the two weeks of each of the treatment periods. 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.
Outcome measures
| Measure |
ADX-N05 300 mg
n=33 Participants
Participants took 2 tablets of 150 mg (300 mg) ADX-N05 once a day during week 2 or week 4 of the 4-week study treatment period.
|
Placebo
n=33 Participants
Participants took Placebo to match ADX-N05 once a day during week 2 or week 4 of the 4-week study treatment period.
|
|---|---|---|
|
Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 2 and 4
|
25 Participants
|
13 Participants
|
Adverse Events
ADX-N05
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ADX-N05
n=33 participants at risk
Participants received ADX-N05 150 mg once a day for seven days followed by 300 mg once a day for seven days during the 4-week study treatment period.
|
Placebo
n=33 participants at risk
Participants received Placebo to match ADX-N05 once a day for 2 consecutive weeks during the 4-week study treatment period.
|
|---|---|---|
|
Nervous system disorders
Headache
|
9.1%
3/33
|
0.00%
0/33
|
|
Nervous system disorders
Initial Insomnia
|
6.1%
2/33
|
0.00%
0/33
|
|
Nervous system disorders
Insomnia
|
6.1%
2/33
|
0.00%
0/33
|
|
Gastrointestinal disorders
Nausea
|
12.1%
4/33
|
0.00%
0/33
|
|
General disorders
Chest discomfort
|
9.1%
3/33
|
0.00%
0/33
|
|
Psychiatric disorders
Anxiety
|
6.1%
2/33
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
6.1%
2/33
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
6.1%
2/33
|
0.00%
0/33
|
Additional Information
Director, Disclosure & Transparency
Jazz Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place