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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-10

Study Completion Date

2008-01-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Narcolepsy With Cataplexy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sodium Oxybate

* 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

Group Type EXPERIMENTAL

Sodium Oxybate (Xyrem)

Intervention Type 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

Interventions

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Sodium Oxybate (Xyrem)

* 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

Intervention Type DRUG