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

UCB

Status and phase: Completed; Phase 1

Conditions: Narcolepsy With Cataplexy

Treatments: Drug: Sodium Oxybate (Xyrem)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00345800

2005-004417-15 (EudraCT Number)

C00301

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion Criteria:

• Narcoleptic patients with cataplexy

Exclusion criteria

• Subjects not diagnosed with narcolepsy with cataplexy

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Sodium Oxybate

Experimental group

Description:

* 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

Treatment:

Drug: Sodium Oxybate (Xyrem)