"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"

Phase 3

Completed

• Conditions: Narcolepsy; Obstructive Sleep Apnea
• Interventions: Drug: JZP-110

• Registration Number: NCT02348632
• Lead Sponsor: Jazz Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-28
• Study Start: 2015-05
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Disposition First Submitted: 2018-12-05
• Disposition First Submitted QC: 2018-12-05
• Disposition First Posted: 2018-12-10
• Results First Submitted: 2019-04-19
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-04
• Last Update Submitted: 2019-06-04
• Results First Posted: 2019-06-25
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 645

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
75 mg - 300 mg of JZP-110	JZP-110	Once Daily Dosing

Primary Outcome Measures

Name	Time	Method
Change in Epworth Sleepiness Scale (ESS) Score	Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Subjects Reported as Worse on the Patient Global Impression of Change (PGIc)	Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)	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.
Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc)	Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)	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.

Trial Locations

Locations (80)

Sleep Disorders Center of Alabama; 🇺🇸 Birmingham, Alabama, United States

Pulmonary Associates; 🇺🇸 Glendale, Arizona, United States

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Preferred Research Partners; 🇺🇸 Little Rock, Arkansas, United States

UC San Diego Medical Center; 🇺🇸 La Jolla, California, United States

So Cal Institute For Respiratory Diseases, Inc.; 🇺🇸 Los Angeles, California, United States

Pacific Sleep Medicine; 🇺🇸 Oceanside, California, United States

The Research Center of Southern California; 🇺🇸 Oceanside, California, United States

Stanford University Center for Narcolepsy; 🇺🇸 Redwood City, California, United States

Pacific Research Network Inc.; 🇺🇸 San Diego, California, United States

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