Brief Summary
This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.
Brief Title
"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
Categories
Completion Date
Completion Date Type
Actual
Conditions
Narcolepsy
Obstructive Sleep Apnea
Eligibility Criteria
Major Inclusion Criteria:
1. Subject meets one of the following:
1. Completed Study 14-002 or 14-003 (Group A)
2. Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)
2. Body mass index from 18 to \<45 kg/m2
3. Consent to use a medically acceptable method of contraception
4. Willing and able to provide written informed consent
Major Exclusion Criteria:
1. Female subjects who are pregnant, nursing, or lactating
2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy or OSA that is associated with excessive sleepiness
3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
4. 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 or safety assessments, or the ability of the subject to complete the trial per the judgment of the Investigator
5. History of bariatric surgery within the past year or a history of roux-en-y procedure
6. Presence or history of significant cardiovascular disease
7. Use of any over the counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
8. Received an investigational drug other than JZP-110 in the past 30 days or five half-lives (whichever is longer)
9. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
1. Subject meets one of the following:
1. Completed Study 14-002 or 14-003 (Group A)
2. Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)
2. Body mass index from 18 to \<45 kg/m2
3. Consent to use a medically acceptable method of contraception
4. Willing and able to provide written informed consent
Major Exclusion Criteria:
1. Female subjects who are pregnant, nursing, or lactating
2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy or OSA that is associated with excessive sleepiness
3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
4. 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 or safety assessments, or the ability of the subject to complete the trial per the judgment of the Investigator
5. History of bariatric surgery within the past year or a history of roux-en-y procedure
6. Presence or history of significant cardiovascular disease
7. Use of any over the counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
8. Received an investigational drug other than JZP-110 in the past 30 days or five half-lives (whichever is longer)
9. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Inclusion Criteria
Inclusion Criteria:
1. Subject meets one of the following:
1. Completed Study 14-002 or 14-003 (Group A)
2. Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)
2. Body mass index from 18 to \<45 kg/m2
3. Consent to use a medically acceptable method of contraception
4. Willing and able to provide written informed consent
Major
1. Subject meets one of the following:
1. Completed Study 14-002 or 14-003 (Group A)
2. Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)
2. Body mass index from 18 to \<45 kg/m2
3. Consent to use a medically acceptable method of contraception
4. 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
NCT02348632
Org Class
Industry
Org Full Name
Jazz Pharmaceuticals
Org Study Id
14-005
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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
Primary Outcomes
Outcome Description
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.
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.
Outcome Measure
Change in Epworth Sleepiness Scale (ESS) Score
Outcome Time Frame
Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks)
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)
Outcome Measure
Subjects Reported as Worse on the Patient Global Impression of Change (PGIc)
Outcome Description
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.
Outcome Time Frame
Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)
Outcome Measure
Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc)
Start Date
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
Imran Ahmed
Investigator Email
iahmed@montefiore.org
Investigator Phone
718-920-4841