NarcolepsyNCT04899947
Child and Adolescent Registry for Participants With Narcolepsy
An observational study of Narcolepsy, run by Jazz Pharmaceuticals at 25 sites in United States.
Trial summary
CATNAP is a patient registry designed to improve the understanding of the natural history of narcolepsy in pediatric patients. Descriptive statistics on disease characteristics will be performed. The study has 16 active clinical sites and a virtual site that widens participation to anywhere in the United States. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Narcolepsy
- How many people
- 500 participants
- Where
- 25 sitesUnited States
- Study dates
- 10 Oct 2020to 1 Oct 2024
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Any child or adolescent with a physician-confirmed diagnosis of narcolepsy
Who may be able to join
- Any child or adolescent with a physician-confirmed diagnosis of narcolepsy
- Age less than 18 years
- Willing to participate in the Registry and complete the informed consent form
- Able to participate in English based registry
Who cannot join
- Age 18 years or more
- Fail to complete the informed consent form
Trial locations and contacts
25 sites in 1 country.
Director Clinical Trial Disclosure & Transparency contact
25 sites in 1 country
United States25 sites, 25 recruiting
- Not yet recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
- Recruiting
St. Luke's Hospital
Chesterfield, Missouri, 63017
- Not yet recruiting
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
- Recruiting
University Hospitals Cleveland Medical Centre (UHCMC)
Cleveland, Ohio, 44106
- Not yet recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
- Recruiting
Geisinger
Danville, Pennsylvania, 17822
- Recruiting
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017
- Not yet recruiting
University of Arkansas
Fayetteville, Arkansas, 72701
- Not yet recruiting
Trinity Health-Michigan
Grand Rapids, Michigan, 49503
- Recruiting
Texas Children's Hospital (Baylor College of Medicine)
Houston, Texas, 77030
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
- Recruiting
Arkansas Children's Research Institute
Little Rock, Arkansas, 72202
- Recruiting
Northwell Health
Manhasset, New York, 11030
- Recruiting
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
- Not yet recruiting
Phoenix Children's Hospital
Phoenix, Arizona, 85016
- Recruiting
Stanford University
Redwood City, California, 94063
- Not yet recruiting
Mayo Clinic
Rochester, Michigan, 55905
- Recruiting
University of California San Diego
San Diego, California, 92093
- Recruiting
University of South Florida
Tampa, Florida, 33620
- Recruiting
University of Arizona
Tucson, Arizona, 85719
- Not yet recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
- Not yet recruiting
Children's Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: Children, Adolescents and Their Providers: the Narcolepsy Assessment Partnership (CATNAPTM)
CATNAP is a patient registry designed to improve the understanding of the natural history of narcolepsy in pediatric patients. Descriptive statistics on disease characteristics will be performed.
The study has 16 active clinical sites and a virtual site that widens participation to anywhere in the United States. For more information about the study or to access the Online Patient Enrollment System, visit the CATNAP website: https://catnap.healthie.net/welcome or email catnap@pulseinfoframe.com. The Online Patient Enrollment System, CATNAP website, can also be found in the references section.
- Conditions
- Narcolepsy
- Medical subject headings
- Narcolepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve Understanding of Natural History of Pediatric Narcolepsy
Measured: Up to 4 years
Characterize the Presentation, Identification, and Diagnosis of Narcolepsy in Pediatric Participants
Measured: Up to 4 years
Understand Treatment Practices and Outcomes Captured by Treatment Regimen and Rational for Changes
Measured: Up to 4 years
Secondary outcomes (9)
Improvements in Quality of Life (QoL) as Measured by Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) Questionnaire
Measured: Up to 4 years
QoL - Pediatric Quality of Life Inventory (PedsQL)
Measured: Up to 4 years
Change in frequency of child ehavioral problems utilizing the Child Behavior Checklist (CBCL)
Measured: Up to 4 years
Patient Reported Outcomes Measurement Information System (PROMIS) Peer Relationship-Parent Proxy Short Form v2.0
Measured: Up to 4 years
Caregiver Work Limitations Questionnaire (C-WLQ)
Measured: Up to 4 years
Work Productivity and Activity Impairment (WPAI)
Measured: Up to 4 years
Change in Caregiver Well-being Measured by the Caregiver Well-Being Scale (Shortened)
Measured: Up to 4 years
Change in Level of Social Support using the Social Support Survey Instrument
Measured: Up to 4 years
Change in Pittsburgh Sleep Quality index (PSQI) scores
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start10 Oct 2020
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899947
- Sponsor's protocol ID
- HealhieCATNAPN.A.
- Status last verified
- Aug 2024
- First submitted
- 30 Apr 2021
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children, Adolescents and Their Providers: the Narcolepsy Assessment Partnership (CATNAPTM)
- ClinicalTrials.gov ID
- NCT04899947
- Acronym / sponsor ID
- HealhieCATNAPN.A.
- Conditions
- Narcolepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CATNAP is a patient registry designed to improve the understanding of the natural history of narcolepsy in pediatric patients. Descriptive statistics on disease characteristics will be performed.
The study has 16 active clinical sites and a virtual site that widens participation to anywhere in the United States. For more information about the study or to access the Online Patient Enrollment System, visit the CATNAP website: https://catnap.healthie.net/welcome or email catnap@pulseinfoframe.com. The Online Patient Enrollment System, CATNAP website, can also be found in the references section.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Any child or adolescent with a physician-confirmed diagnosis of narcolepsy
Key inclusion criteria (4 listed)
- Any child or adolescent with a physician-confirmed diagnosis of narcolepsy
- Age less than 18 years
- Willing to participate in the Registry and complete the informed consent form
- Able to participate in English based registry
Key exclusion criteria (2 listed)
- Age 18 years or more
- Fail to complete the informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improve Understanding of Natural History of Pediatric Narcolepsy
Time frame: Up to 4 years
Characterize the Presentation, Identification, and Diagnosis of Narcolepsy in Pediatric Participants
Time frame: Up to 4 years
Understand Treatment Practices and Outcomes Captured by Treatment Regimen and Rational for Changes
Time frame: Up to 4 years
9 secondary outcomes
Improvements in Quality of Life (QoL) as Measured by Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) Questionnaire
Time frame: Up to 4 years
QoL - Pediatric Quality of Life Inventory (PedsQL)
Time frame: Up to 4 years
Change in frequency of child ehavioral problems utilizing the Child Behavior Checklist (CBCL)
Time frame: Up to 4 years
Patient Reported Outcomes Measurement Information System (PROMIS) Peer Relationship-Parent Proxy Short Form v2.0
Time frame: Up to 4 years
Caregiver Work Limitations Questionnaire (C-WLQ)
Time frame: Up to 4 years
Work Productivity and Activity Impairment (WPAI)
Time frame: Up to 4 years
Change in Caregiver Well-being Measured by the Caregiver Well-Being Scale (Shortened)
Time frame: Up to 4 years
Change in Level of Social Support using the Social Support Survey Instrument
Time frame: Up to 4 years
Change in Pittsburgh Sleep Quality index (PSQI) scores
Time frame: Up to 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Online Patient Enrollment SystemLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Director Clinical Trial Disclosure & Transparency contact
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narcolepsy, run by Jazz Pharmaceuticals at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Director Clinical Trial Disclosure & Transparency (2158709177, ClinicalTrialDisclosure@JazzPharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve Understanding of Natural History of Pediatric Narcolepsy (time frame: Up to 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.