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 g/day divided into two equal doses)during twelve weeks of treatment of cataplexy in adult patients with narcolepsy. - C00301

• Conditions: Cataplexy in adult patients with narcolepsy

• Registration Number: EUCTR2005-004417-15-BE
• Lead Sponsor: CB Pharma Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-04
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

To be eligible to participate in this study, all of the following criteria must be met:

·Male or female subjects, aged from 18 to 65 years inclusive, from any racial group;
·Written informed consent dated and signed by the subject;
·The subject must have met criteria for a primary diagnosis of narcolepsy with cataplexy:
·Daytime sleepiness daily for at least 3 months
·Inadvertent naps / Sleep attacks
·Bilateral postural muscle weakness triggered by emotions;
·The subject must demonstrate an adequate need for cataplexy treatment, as determined by the Investigator, based on a review of the subject’s history and any relevant clinical findings. The subject must either have a need for, or have had an adequate response to standard treatment as determined by the treating physician;
·Female subjects without childbearing potential (2 years post-menopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they are sexually abstinent or if they use a medically accepted contraceptive method (hormonal contraception must be stable since at least 3 months before entry in the study and must be continued until the end of the study because of the influence on IGF-1 levels);
·Be considered as reliable and capable of adhering to the protocol, according to the judgment of the investigator.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects must be excluded if they meet any of the following criteria:

·History or presence of cardiovascular, respiratory, hepatic/biliary, renal, gastrointestinal, endocrinological, neurological disorders capable of altering the absorption, distribution, metabolism or elimination of drugs, or constituting a possible risk factor when taking the study medication. A blood sampling and urinalysis taken within the 3 months preceding the screening or at screening must demonstrate there is no risk according to the investigator’s judgment to include the subject (see section 11.1.7);
·History of clinically significant hypersensitivity or allergy to sodium oxybate or to any of the excipients;
·History or presence of drug addiction (positive drug screen), or excessive use of alcohol (positive alcohol breath test);
·Patients with succinic semialdehyde dehydrogenase deficiency;
·Patients being treated with sedative hypnotics, other CNS depressants, corticoids (which are not taken at a stable dose for at least two months. No topical, intra-muscular or intra-venous formulation), opioids or barbiturates during one week (one month for enzyme-inducers) preceding the study drug administration;
·Participation in another clinical trial less than 3 months before the present study;
·Subjects who, in the judgment of the investigator, are likely to be non reliable or non-compliant or uncooperative during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ·To monitor for endocrine changes in response to treatment of cataplexy with Xyrem<br>·To focus on the hypothalamic pituitary axis<br>;Secondary Objective: ·To confirm the safety of Xyrem on potential endocrine changes;Primary end point(s): ·IGF-1: Single daily measurement at Baseline, month 1 and month 3 visits, in fasting conditions, around 6 am (ca 8 h after bedtime dose)