Completed PHASE1 INTERVENTIONAL 1-arm NCT00345800

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

Single Center, Therapeutic Exploratory Clinical Trial to Evaluate the Safety of Sodium Oxybate (Xyrem) 500 mg/mL Oral Solution on Potential Endocrine Changes at Currently Labeled Therapeutic Dose Regimens (4.5 - 9 g/Day Divided Into Two Equal Doses) During 12 Weeks of Treatment of Cataplexy in Adult Patients With Narcolepsy.

Sponsor: UCB Pharma SA

Conditions Narcolepsy With Cataplexy

Interventions Sodium Oxybate (Xyrem)

Updated 8 times since 2017 Last updated: Feb 9, 2022 Started: Apr 10, 2006 Primary completion: Jan 22, 2008 Completion: Jan 22, 2008

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00345800, this PHASE1 trial focuses on Narcolepsy With Cataplexy and remains completed. Sponsored by UCB Pharma SA, it has been updated 8 times since 2006, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

8 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2023 — Jul 2024 [monthly]

Completed PHASE1
Dec 2022 — Jan 2023 [monthly]

Completed PHASE1
May 2022 — Dec 2022 [monthly]

Completed PHASE1

Phase: PHASE4 → PHASE1

▶ Show 3 earlier versions

Jan 2021 — May 2022 [monthly]

Completed PHASE4
Jun 2018 — Jan 2021 [monthly]

Completed PHASE4
Jan 2017 — Jun 2018 [monthly]

Completed PHASE4

First recorded

Apr 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

UCB Pharma SA

Data source: UCB Pharma

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Liège, Belgium