Observational Study of LUMRYZ in Narcolepsy

Avadel71 enrolled

Overview

This is an observational study of LUMRYZ prescribed in clinical practice. Patients are asked if they would be willing to complete questionnaires over a 4-month period after starting LUMRYZ. The questionnaires ask about narcolepsy symptoms, experience with LUMRYZ, and quality of life.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Narcolepsy

Interventions

LUMRYZDRUG

Prescribed for narcolepsy in accordance with product label.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults with narcolepsy * Oxybate naive or prior treatment with twice-nightly oxybate * Access to smart phone, tablet or laptop with reliable internet connection * Able to read/understand English * Written informed consent and ability to comply with schedule Exclusion Criteria: * Already using LUMRYZ * Clinical or mental health condition excluded by LUMRYZ label * Any other condition/situation that would adversely impact participation

Locations (12)

Jeremy D McConnell, MD PA

Bradenton, Florida, United States

Comprehensive Sleep Center

East Lansing, Michigan, United States

Patient First MD

Middletown, New Jersey, United States

Outcomes

Primary Outcomes

Epworth Sleepiness Scale

Change from the first visit (baseline), prior to start of LUMRYZ, to Month 4; measure of sleepiness with total possible score of 0-24 (higher score equivalent to higher sleepiness)

Time frame: Baseline to Month 4

Data from ClinicalTrials.gov

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