Conditions: Narcolepsy With Cataplexy
Keywords: Endocrine Evaluation cataplexy sodium oxybate (xyrem)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: * 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: intervention 1: Sodium Oxybate (Xyrem)
Intervention descriptions: intervention 1: * 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

Protocol document: