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

February 9, 2022 updated by: UCB Pharma SA

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Inclusion Criteria:

  • Narcoleptic patients with cataplexy

Exclusion Criteria:

  • Subjects not diagnosed with narcolepsy with cataplexy

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Drug: 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
Other Names:
  • Xyrem

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2)
Time Frame: Baseline (Visit 2) - approximately 1 day
An assay of IGF-1 was done from blood sampled about 10 hours after bedtime on Visit 2.
Baseline (Visit 2) - approximately 1 day
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3)
Time Frame: After 1 month of treatment (Visit 3)
An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 3.
After 1 month of treatment (Visit 3)
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4)
Time Frame: After 3 months of treatment (Visit 4)
An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 4.
After 3 months of treatment (Visit 4)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2)
Time Frame: Baseline (Visit 2) - approximately 1 day
Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying GH.
Baseline (Visit 2) - approximately 1 day
The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3
Time Frame: Visit 3 (approximately 1 month)
Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying GH.
Visit 3 (approximately 1 month)
The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4
Time Frame: Visit 4 (approximately 3 months)
Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying GH.
Visit 4 (approximately 3 months)
Cortisol Measured at Baseline (Visit 2)
Time Frame: Baseline (Visit 2) - approximately 1 day
Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying cortisol.
Baseline (Visit 2) - approximately 1 day
Cortisol Measured at Visit 3
Time Frame: Visit 3 (approximately 1 month)
Blood was sampled predose and and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying cortisol.
Visit 3 (approximately 1 month)
Cortisol Measured at Visit 4
Time Frame: Visit 4 (approximately 3 months)
Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying cortisol.
Visit 4 (approximately 3 months)
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2)
Time Frame: Baseline (Visit 2) - approximately 1 day
An assay of ACTH was done from blood sampled about 10 hours after bedtime on Visit 2.
Baseline (Visit 2) - approximately 1 day
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 3
Time Frame: Visit 3 (approximately 1 month)
An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 3.
Visit 3 (approximately 1 month)
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 4
Time Frame: Visit 4 (approximately 3 months)
An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 4.
Visit 4 (approximately 3 months)
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Baseline (Visit 2)
Time Frame: Baseline (Visit 2) - approximately 1 day
An assay of DHEA-S was done from blood sampled about 10 hours after bedtime on Visit 2.
Baseline (Visit 2) - approximately 1 day
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 3
Time Frame: Visit 3 (approximately 1 month)
An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 3.
Visit 3 (approximately 1 month)
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 4
Time Frame: Visit 4 (approximately 3 months)
An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 4.
Visit 4 (approximately 3 months)
The Prolactin Measured in Fasting Conditions at Baseline (Visit 2)
Time Frame: Baseline (Visit 2) - approximately 1 day
An assay of prolactin was done from blood sampled about 10 hours after bedtime on Visit 2.
Baseline (Visit 2) - approximately 1 day
The Prolactin Measured in Fasting Conditions at Visit 3
Time Frame: Visit 3 (approximately 1 month)
An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 3.
Visit 3 (approximately 1 month)
The Prolactin Measured in Fasting Conditions at Visit 4
Time Frame: Visit 4 (approximately 3 months)
An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 4.
Visit 4 (approximately 3 months)
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Baseline (Visit 2)
Time Frame: Baseline (Visit 2) - approximately 1 day
An assay of TSH was done from blood sampled about 10 hours after bedtime on Visit 2.
Baseline (Visit 2) - approximately 1 day
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 3
Time Frame: Visit 3 (approximately 1 month)
An assay of TSH was done from blood sampled about 10 hours postdose on Visit 3.
Visit 3 (approximately 1 month)
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 4
Time Frame: Visit 4 (approximately 3 months)
An assay of TSH was done from blood sampled about 10 hours postdose on Visit 4.
Visit 4 (approximately 3 months)
The Total Thyroxin (T4) Measured in Fasting Conditions at Baseline (Visit 2)
Time Frame: Baseline (Visit 2) - approximately 1 day
An assay of T4 was done from blood sampled about 10 hours after bedtime on Visit 2.
Baseline (Visit 2) - approximately 1 day
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 3
Time Frame: Visit 3 (approximately 1 month)
An assay of T4 was done from blood sampled about 10 hours postdose on Visit 3.
Visit 3 (approximately 1 month)
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 4
Time Frame: Visit 4 (approximately 3 months)
An assay of T4 was done from blood sampled about 10 hours postdose on Visit 4.
Visit 4 (approximately 3 months)
The Osmolality Measured in Fasting Conditions at Baseline (Visit 2)
Time Frame: Baseline (Visit 2) - approximately 1 day
An assay of osmolality was done from blood sampled about 10 hours after bedtime on Visit 2.
Baseline (Visit 2) - approximately 1 day
The Osmolality Measured in Fasting Conditions at Visit 3
Time Frame: Visit 3 (approximately 1 month)
An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 3.
Visit 3 (approximately 1 month)
The Osmolality Measured in Fasting Conditions at Visit 4
Time Frame: Visit 4 (approximately 3 months)
An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 4.
Visit 4 (approximately 3 months)
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Baseline (Visit 2)
Time Frame: Baseline (Visit 2) - approximately 1 day
An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2.
Baseline (Visit 2) - approximately 1 day
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Baseline (Visit 2)
Time Frame: Baseline (Visit 2) - approximately 1 day
An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2.
Baseline (Visit 2) - approximately 1 day
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 3
Time Frame: Visit 3 (approximately 1 month)
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3.
Visit 3 (approximately 1 month)
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 3
Time Frame: Visit 3 (approximately 1 month)
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3.
Visit 3 (approximately 1 month)
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 4
Time Frame: Visit 4 (approximately 3 months)
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4.
Visit 4 (approximately 3 months)
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 4
Time Frame: Visit 4 (approximately 3 months)
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4.
Visit 4 (approximately 3 months)
The Number of Patients Reporting at Least One Adverse Event (AE) During the Course of the Study
Time Frame: Visit 1 through the end of the study (approximately 4 months)
An AE was classified as a treatment-emergent AE (TEAE) if its onset date and time was on or after the first study drug administration. Number of subjects with at least one TEAE is reported below.
Visit 1 through the end of the study (approximately 4 months)
The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study
Time Frame: Visit 1 through the end of the study (approximately 4 months)
An AE was classified as a treatment-emergent AE (TEAE) if its onset date and time was on or after the first study drug administration. Number of subjects with TEAE that led to temporarily discontinuation of study drug is reported below.
Visit 1 through the end of the study (approximately 4 months)
The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study
Time Frame: Visit 1 through the end of the study (approximately 4 months)
A Serious Adverse Event is any untoward medical occurrence that at any dose • results in death, • is life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect
Visit 1 through the end of the study (approximately 4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB Pharma SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 22, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 22, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2006

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C00301
  • 2005-004417-15 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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