Brief Summary
This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.
Brief Title
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
Categories
Completion Date
Completion Date Type
Actual
Conditions
Narcolepsy
Eligibility Criteria
Major Inclusion Criteria:
1. Males and females between 18 and 75 years of age, inclusive
2. Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria
3. Body mass index from 18 to \<45 kg/m2
4. Consent to use a medically acceptable method of contraception
5. Willing and able to provide written informed consent
Major Exclusion Criteria:
1. Female subjects who are pregnant, nursing, or lactating
2. Moderate or severe sleep apnea on the baseline PSG.
3. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
4. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
5. History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator
6. History of bariatric surgery within the past year or a history of any gastic bypass procedure
7. Presence or history of significant cardiovascular disease
8. Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
9. Use of any medications that could affect the evaluation of cataplexy
10. Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
11. Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A)
12. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
1. Males and females between 18 and 75 years of age, inclusive
2. Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria
3. Body mass index from 18 to \<45 kg/m2
4. Consent to use a medically acceptable method of contraception
5. Willing and able to provide written informed consent
Major Exclusion Criteria:
1. Female subjects who are pregnant, nursing, or lactating
2. Moderate or severe sleep apnea on the baseline PSG.
3. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
4. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
5. History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator
6. History of bariatric surgery within the past year or a history of any gastic bypass procedure
7. Presence or history of significant cardiovascular disease
8. Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
9. Use of any medications that could affect the evaluation of cataplexy
10. Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
11. Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A)
12. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Inclusion Criteria
Inclusion Criteria:
1. Males and females between 18 and 75 years of age, inclusive
2. Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria
3. Body mass index from 18 to \<45 kg/m2
4. Consent to use a medically acceptable method of contraception
5. Willing and able to provide written informed consent
Major
1. Males and females between 18 and 75 years of age, inclusive
2. Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria
3. Body mass index from 18 to \<45 kg/m2
4. Consent to use a medically acceptable method of contraception
5. Willing and able to provide written informed consent
Major
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT02348593
Org Class
Industry
Org Full Name
Jazz Pharmaceuticals
Org Study Id
14-002
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, 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 Narcolepsy
Primary Outcomes
Outcome Description
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.
Outcome Measure
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12
Outcome Time Frame
Baseline to Week 12
Outcome Description
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.
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.
Outcome Measure
Change in ESS Score From Baseline to Week 12
Outcome Time Frame
Baseline to Week 12
Secondary Outcomes
Outcome Description
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
Outcome Time Frame
Baseline to Week 12
Outcome Measure
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12
Outcome Description
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Outcome Time Frame
Change from baseline for sleep latency in MWT during trial 1 at week 12
Outcome Measure
Change in Sleep Latency Time on MWT Trial 1 at Week 12
Outcome Description
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Outcome Time Frame
Change from baseline for sleep latency in MWT during trial 2 at week 12
Outcome Measure
Change in Sleep Latency Time on MWT Trial 2 at Week 12
Outcome Description
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Outcome Time Frame
Change from baseline for sleep latency in MWT during trial 3 at week 12
Outcome Measure
Change in Sleep Latency Time on MWT Trial 3 at Week 12
Outcome Description
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Outcome Time Frame
Change from baseline for sleep latency in MWT during trial 4 at week 12
Outcome Measure
Change in Sleep Latency Time on MWT Trial 4 at Week 12
Outcome Description
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Outcome Time Frame
Change from baseline for sleep latency in MWT during trial 5 at week 12
Outcome Measure
Change in Sleep Latency Time on MWT Trial 5 at Week 12
Outcome Description
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.
Outcome Time Frame
Baseline to Week 4
Outcome Measure
Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-Minute MWT From Baseline to Week 4
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Michael Thorpy
Investigator Email
michael.thorpy@einsteinmed.org
Investigator Phone
718-920-4841