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Child and Adolescent Registry for Participants With Narcolepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04899947
Recruitment Status : Recruiting
First Posted : May 25, 2021
Last Update Posted : December 1, 2022
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Brief 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. 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.


Condition or disease
Narcolepsy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: Children, Adolescents and Their Providers: the Narcolepsy Assessment Partnership (CATNAPTM)
Actual Study Start Date : October 10, 2020
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Improve Understanding of Natural History of Pediatric Narcolepsy [ Time Frame: Up to 4 years ]
  2. Characterize the Presentation, Identification, and Diagnosis of Narcolepsy in Pediatric Participants [ Time Frame: Up to 4 years ]
  3. Understand Treatment Practices and Outcomes Captured by Treatment Regimen and Rational for Changes [ Time Frame: Up to 4 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. QoL - Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: Up to 4 years ]
  3. Change in frequency of child ehavioral problems utilizing the Child Behavior Checklist (CBCL) [ Time Frame: Up to 4 years ]
  4. Patient Reported Outcomes Measurement Information System (PROMIS) Peer Relationship-Parent Proxy Short Form v2.0 [ Time Frame: Up to 4 years ]
  5. Caregiver Work Limitations Questionnaire (C-WLQ) [ Time Frame: Up to 4 years ]
  6. Work Productivity and Activity Impairment (WPAI) [ Time Frame: Up to 4 years ]
  7. Change in Caregiver Well-being Measured by the Caregiver Well-Being Scale (Shortened) [ Time Frame: Up to 4 years ]
  8. Change in Level of Social Support using the Social Support Survey Instrument [ Time Frame: Up to 4 years ]
  9. Change in Pittsburgh Sleep Quality index (PSQI) scores [ Time Frame: Up to 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any child or adolescent with a physician-confirmed diagnosis of narcolepsy
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age 18 years or more
  • Fail to complete the informed consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04899947


Contacts
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Contact: Director Clinical Trial Disclosure & Transparency 2158709177 ClinicalTrialDisclosure@JazzPharma.com

Locations
Show Show 25 study locations
Sponsors and Collaborators
Jazz Pharmaceuticals
Additional Information:
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Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04899947    
Other Study ID Numbers: HealhieCATNAPN.A.
First Posted: May 25, 2021    Key Record Dates
Last Update Posted: December 1, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders