Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes

GHB

Brief Summary

To monitor for endocrine changes in response to treatment of cataplexy with Xyrem, to focus on the hypothalamic pituitary axis and to confirm the safety of Xyrem on potential endocrine changes.

Intervention / Treatment

  • Sodium Oxybate (Xyrem) (DRUG)
    * Active Substance: Sodium Oxybate * Pharmaceutical form: Oral Solution * Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks * Route of administration: Oral

Condition or Disease

  • Narcolepsy With Cataplexy

Phase

  • Phase 1
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 25 (ACTUAL)
    Funded by: Industry
    Allocation: N/A
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Apr 10, 2006 ACTUAL
    Primary Completion: Jan 22, 2008 ACTUAL
    Completion Date: Jan 22, 2008 ACTUAL
    Study First Posted: Jun 29, 2006 ESTIMATED
    Results First Posted: Apr 08, 2022 ACTUAL
    Last Updated: Feb 09, 2022

    Sponsors / Collaborators

    Lead Sponsor: UCB Pharma SA
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Participant Groups

    • * Active Substance: Sodium Oxybate * Pharmaceutical form: Oral Solution * Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks * Route of administration: Oral

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    Inclusion Criteria:

    * Narcoleptic patients with cataplexy

    Exclusion Criteria:

    * Subjects not diagnosed with narcolepsy with cataplexy

    Exclusion Criteria:

    Primary Outcomes
    • An assay of IGF-1 was done from blood sampled about 10 hours after bedtime on Visit 2.

    • An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 3.

    • An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 4.

    Secondary Outcomes
    • Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying GH.

    • Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying GH.

    • Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying GH.

    • Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying cortisol.

    • Blood was sampled predose and and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying cortisol.

    • Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying cortisol.

    • An assay of ACTH was done from blood sampled about 10 hours after bedtime on Visit 2.

    • An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 3.

    • An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 4.

    • An assay of DHEA-S was done from blood sampled about 10 hours after bedtime on Visit 2.

    • An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 3.

    • An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 4.

    • An assay of prolactin was done from blood sampled about 10 hours after bedtime on Visit 2.

    • An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 3.

    • An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 4.

    • An assay of TSH was done from blood sampled about 10 hours after bedtime on Visit 2.

    • An assay of TSH was done from blood sampled about 10 hours postdose on Visit 3.

    • An assay of TSH was done from blood sampled about 10 hours postdose on Visit 4.

    • An assay of T4 was done from blood sampled about 10 hours after bedtime on Visit 2.

    • An assay of T4 was done from blood sampled about 10 hours postdose on Visit 3.

    • An assay of T4 was done from blood sampled about 10 hours postdose on Visit 4.

    • An assay of osmolality was done from blood sampled about 10 hours after bedtime on Visit 2.

    • An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 3.

    • An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 4.

    • An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2.

    • An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2.

    • An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3.

    • An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3.

    • An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4.

    • An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4.

    • An AE was classified as a treatment-emergent AE (TEAE) if its onset date and time was on or after the first study drug administration. Number of subjects with at least one TEAE is reported below.

    • An AE was classified as a treatment-emergent AE (TEAE) if its onset date and time was on or after the first study drug administration. Number of subjects with TEAE that led to temporarily discontinuation of study drug is reported below.

    • A Serious Adverse Event is any untoward medical occurrence that at any dose • results in death, • is life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect

    More Details

    NCT Number: NCT00345800
    Other IDs: C00301
    Study URL: https://clinicaltrials.gov/study/NCT00345800
    Last updated: Sep 29, 2023