Effect of sodium oxybate on body mass index in pediatric patients with narcolepsy.

ABSTRACT:

Study objectives

We examined body mass index (BMI) changes associated with sodium oxybate treatment (SXB) in pediatric patients with narcolepsy with cataplexy who participated in a double-blind, placebo-controlled, randomized withdrawal study and an open-label continuation period.

Methods

Participants were aged 7-16 years at screening. SXB-naive participants titrated to twice-nightly dosing of SXB then entered a 2-week stable-dose period; participants taking SXB at study entry entered a 3-week stable-dose period. After a 2-week randomized withdrawal period, all participants entered an open-label safety period (OLP; main study duration: ≤ 52 weeks). Participants who completed the OLP were allowed to enter the open-label continuation period (an additional 1-2 years). BMI perce

SUBMITTER: Dauvilliers Y 

PROVIDER: S-EPMC11019206 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature