Narcolepsy With CataplexyPhase 1NCT00345800
Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
A Phase 1 study testing Sodium Oxybate (Xyrem) in people with Narcolepsy With Cataplexy, run by UCB Pharma SA at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Narcolepsy With Cataplexy
- What is being tested?
- Sodium Oxybate (Xyrem)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Apr 2006to 22 Jan 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Narcoleptic patients with cataplexy
Who cannot join
- Subjects not diagnosed with narcolepsy with cataplexy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Narcolepsy With Cataplexy
- Being tested
- Sodium Oxybate (Xyrem)
- Keywords
- Endocrine Evaluation cataplexy, sodium oxybate (xyrem)
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Oxybate (Xyrem)Drug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Sodium Oxybate | Experimental | * 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 Receives: Drug: Sodium Oxybate (Xyrem) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of IGF-1 was done from blood sampled about 10 hours after bedtime on Visit 2.
Measured: 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)
An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 3.
Measured: 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)
An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 4.
Measured: After 3 months of treatment (Visit 4)
Secondary outcomes (33)
The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2)
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.
Measured: Baseline (Visit 2) - approximately 1 day
The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3
Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying GH.
Measured: Visit 3 (approximately 1 month)
The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4
Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying GH.
Measured: Visit 4 (approximately 3 months)
Cortisol Measured at Baseline (Visit 2)
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.
Measured: Baseline (Visit 2) - approximately 1 day
Cortisol Measured at Visit 3
Blood was sampled predose and and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying cortisol.
Measured: Visit 3 (approximately 1 month)
Cortisol Measured at Visit 4
Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying cortisol.
Measured: Visit 4 (approximately 3 months)
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of ACTH was done from blood sampled about 10 hours after bedtime on Visit 2.
Measured: Baseline (Visit 2) - approximately 1 day
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 3
An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 3.
Measured: Visit 3 (approximately 1 month)
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 4
An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 4.
Measured: Visit 4 (approximately 3 months)
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of DHEA-S was done from blood sampled about 10 hours after bedtime on Visit 2.
Measured: Baseline (Visit 2) - approximately 1 day
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 3
An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 3.
Measured: Visit 3 (approximately 1 month)
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 4
An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 4.
Measured: Visit 4 (approximately 3 months)
The Prolactin Measured in Fasting Conditions at Baseline (Visit 2)
An assay of prolactin was done from blood sampled about 10 hours after bedtime on Visit 2.
Measured: Baseline (Visit 2) - approximately 1 day
The Prolactin Measured in Fasting Conditions at Visit 3
An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 3.
Measured: Visit 3 (approximately 1 month)
The Prolactin Measured in Fasting Conditions at Visit 4
An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 4.
Measured: Visit 4 (approximately 3 months)
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of TSH was done from blood sampled about 10 hours after bedtime on Visit 2.
Measured: Baseline (Visit 2) - approximately 1 day
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 3
An assay of TSH was done from blood sampled about 10 hours postdose on Visit 3.
Measured: Visit 3 (approximately 1 month)
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 4
An assay of TSH was done from blood sampled about 10 hours postdose on Visit 4.
Measured: Visit 4 (approximately 3 months)
The Total Thyroxin (T4) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of T4 was done from blood sampled about 10 hours after bedtime on Visit 2.
Measured: Baseline (Visit 2) - approximately 1 day
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 3
An assay of T4 was done from blood sampled about 10 hours postdose on Visit 3.
Measured: Visit 3 (approximately 1 month)
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 4
An assay of T4 was done from blood sampled about 10 hours postdose on Visit 4.
Measured: Visit 4 (approximately 3 months)
The Osmolality Measured in Fasting Conditions at Baseline (Visit 2)
An assay of osmolality was done from blood sampled about 10 hours after bedtime on Visit 2.
Measured: Baseline (Visit 2) - approximately 1 day
The Osmolality Measured in Fasting Conditions at Visit 3
An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 3.
Measured: Visit 3 (approximately 1 month)
The Osmolality Measured in Fasting Conditions at Visit 4
An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 4.
Measured: Visit 4 (approximately 3 months)
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2.
Measured: Baseline (Visit 2) - approximately 1 day
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2.
Measured: Baseline (Visit 2) - approximately 1 day
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 3
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3.
Measured: Visit 3 (approximately 1 month)
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 3
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3.
Measured: Visit 3 (approximately 1 month)
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 4
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4.
Measured: Visit 4 (approximately 3 months)
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 4
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4.
Measured: Visit 4 (approximately 3 months)
The Number of Patients Reporting at Least One Adverse Event (AE) During the Course of the Study
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.
Measured: 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
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.
Measured: 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
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
Measured: Visit 1 through the end of the study (approximately 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study start10 Apr 2006
- Primary completion22 Jan 2008
- Study completion22 Jan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Narcolepsy With CataplexyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +1 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345800
- Sponsor's protocol ID
- C00301
- Other IDs
- 2005-004417-15, 2005
- Status last verified
- Feb 2022
- First submitted
- 28 Jun 2006
- Last updated
- 8 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00345800
- Acronym / sponsor ID
- C00301
- Conditions
- Narcolepsy With Cataplexy
- Keywords
- Endocrine Evaluation cataplexy, sodium oxybate (xyrem)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- UCB Pharma SAIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2006 (actual)
- Primary completion
- 22 Jan 2008 (actual)
- Study completion
- 22 Jan 2008 (actual)
- First posted
- 29 Jun 2006 (estimated)
- Results
- Posted 8 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sodium Oxybate | Experimental | 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Narcoleptic patients with cataplexy
Key exclusion criteria (1 listed)
- Subjects not diagnosed with narcolepsy with cataplexy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Oxybate (Xyrem)Also: 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 | Drug | Sodium Oxybate |
Primary outcome
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.
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.
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.
33 secondary outcomes
The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2)
Time frame: 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)
The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4
Time frame: Visit 4 (approximately 3 months)
Cortisol Measured at Baseline (Visit 2)
Time frame: Baseline (Visit 2) - approximately 1 day
Cortisol Measured at Visit 3
Time frame: Visit 3 (approximately 1 month)
Cortisol Measured at Visit 4
Time frame: 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
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 3
Time frame: Visit 3 (approximately 1 month)
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 4
Time frame: 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
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 3
Time frame: Visit 3 (approximately 1 month)
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 4
Time frame: Visit 4 (approximately 3 months)
The Prolactin Measured in Fasting Conditions at Baseline (Visit 2)
Time frame: Baseline (Visit 2) - approximately 1 day
The Prolactin Measured in Fasting Conditions at Visit 3
Time frame: Visit 3 (approximately 1 month)
The Prolactin Measured in Fasting Conditions at Visit 4
Time frame: 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
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 3
Time frame: Visit 3 (approximately 1 month)
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 4
Time frame: 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
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 3
Time frame: Visit 3 (approximately 1 month)
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 4
Time frame: Visit 4 (approximately 3 months)
The Osmolality Measured in Fasting Conditions at Baseline (Visit 2)
Time frame: Baseline (Visit 2) - approximately 1 day
The Osmolality Measured in Fasting Conditions at Visit 3
Time frame: Visit 3 (approximately 1 month)
The Osmolality Measured in Fasting Conditions at Visit 4
Time frame: 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
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Baseline (Visit 2)
Time frame: Baseline (Visit 2) - approximately 1 day
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 3
Time frame: Visit 3 (approximately 1 month)
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 3
Time frame: Visit 3 (approximately 1 month)
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 4
Time frame: Visit 4 (approximately 3 months)
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 4
Time frame: 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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
+1 844 599 2273 (UCB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sodium Oxybate (Xyrem) in people with Narcolepsy With Cataplexy, run by UCB Pharma SA at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2) (time frame: Baseline (Visit 2) - approximately 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.