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This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo, Then ADX-N05 | Experimental | Participants first receive a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 1 and 2). They will then receive 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). |
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| ADX-N05, Then Placebo | Placebo Comparator | Participants first receive 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 will then receive a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 3 and 4). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADX-N05 | Drug | 150 mg once a day for seven days followed by 300 mg once a day for seven days |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Baseline up to 2 weeks post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 1 and 3 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates | Phoenix | Arizona | 85006 | United States | ||
| Clinical Research Group of St. Petersburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26298786 | Derived | Bogan RK, Feldman N, Emsellem HA, Rosenberg R, Lu Y, Bream G, Khayrallah M, Lankford DA. Effect of oral JZP-110 (ADX-N05) treatment on wakefulness and sleepiness in adults with narcolepsy. Sleep Med. 2015 Sep;16(9):1102-8. doi: 10.1016/j.sleep.2015.05.013. Epub 2015 Jun 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | ADX-N05, Then Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention (2 Weeks) |
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| Placebo | Drug | Placebo to match ADX-N05 once a day for 2 consecutive weeks |
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| Baseline up to Week 3 post-dose. |
| Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 2 and 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. | Baseline up to Week 4 post-dose. |
| Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 1 and 3 | 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. | Week 1 and Week 3 post-dose. |
| Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 2 and 4 | 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. | Week 2 and Week 4 post-dose. |
| St. Petersburg |
| Florida |
| 33707 |
| United States |
| Neurotrials Research, Inc. | Atlanta | Georgia | 30342 | United States |
| Sleep Disorders Center of Georgia | Atlanta | Georgia | 30342 | United States |
| SleepMed of Central Georgia | Macon | Georgia | 31201 | United States |
| The Center for Sleep and Wake Disorders | Chevy Chase | Maryland | 20815 | United States |
| Mercy St. Anne Sleep Disorders Center | Toledo | Ohio | 43623 | United States |
| SleepMed of South Carolina | Columbia | South Carolina | 29201 | United States |
| Future Search Trials of Neurology | Austin | Texas | 78731 | United States |
| Sleep Medicine Associates of Texas | Dallas | Texas | 75231 | United States |
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). |
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| NOT COMPLETED |
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| Second Intervention (2 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Posted | Mean | Standard Deviation | minutes | Baseline up to 2 weeks post-dose. |
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| Secondary | Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 1 and 3 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Week 3 post-dose. |
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| Secondary | Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 2 and 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Week 4 post-dose. |
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| Secondary | Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 1 and 3 | 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. | Posted | Count of Participants | Participants | Week 1 and Week 3 post-dose. |
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| Secondary | Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 2 and 4 | 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. | Posted | Count of Participants | Participants | Week 2 and Week 4 post-dose. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ADX-N05 | 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. | 0 | 33 | 0 | 33 | 20 | 33 |
| EG001 | Placebo | Participants received Placebo to match ADX-N05 once a day for 2 consecutive weeks during the 4-week study treatment period. | 0 | 33 | 0 | 33 | 0 | 33 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Initial Insomnia | Nervous system disorders | Systematic Assessment |
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| Insomnia | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Chest discomfort | General disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Muscle tightness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Disclosure & Transparency | Jazz Pharmaceuticals | (215) 970-7145 | ClinicalTrialDisclosure@JazzPharma.com |
| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000623308 | solriamfetol |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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| Participants |
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| Participants |
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