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NCT00345800 Clinical Trial

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

Narcolepsy With Cataplexy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00345800
Other study ID # C00301
Secondary ID 2005-004417-15
Status Completed
Phase Phase 1
First received
Last updated
Start date April 10, 2006
Est. completion date January 22, 2008

Study information
Verified date February 2022
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date January 22, 2008
Est. primary completion date January 22, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Inclusion Criteria: - Narcoleptic patients with cataplexy Exclusion Criteria: - Subjects not diagnosed with narcolepsy with cataplexy Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
UCB Pharma SA

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Baseline (Visit 2) - approximately 1 day
Primary 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. After 1 month of treatment (Visit 3)
Primary 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. After 3 months of treatment (Visit 4)
Secondary 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. Baseline (Visit 2) - approximately 1 day
Secondary 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. Visit 3 (approximately 1 month)
Secondary 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. Visit 4 (approximately 3 months)
Secondary 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. Baseline (Visit 2) - approximately 1 day
Secondary 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. Visit 3 (approximately 1 month)
Secondary 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. Visit 4 (approximately 3 months)
Secondary 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. Baseline (Visit 2) - approximately 1 day
Secondary 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. Visit 3 (approximately 1 month)
Secondary 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. Visit 4 (approximately 3 months)
Secondary 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. Baseline (Visit 2) - approximately 1 day
Secondary 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. Visit 3 (approximately 1 month)
Secondary 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. Visit 4 (approximately 3 months)
Secondary 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. Baseline (Visit 2) - approximately 1 day
Secondary 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. Visit 3 (approximately 1 month)
Secondary 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. Visit 4 (approximately 3 months)
Secondary 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. Baseline (Visit 2) - approximately 1 day
Secondary 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. Visit 3 (approximately 1 month)
Secondary 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. Visit 4 (approximately 3 months)
Secondary 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. Baseline (Visit 2) - approximately 1 day
Secondary 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. Visit 3 (approximately 1 month)
Secondary 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. Visit 4 (approximately 3 months)
Secondary 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. Baseline (Visit 2) - approximately 1 day
Secondary 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. Visit 3 (approximately 1 month)
Secondary 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. Visit 4 (approximately 3 months)
Secondary 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. Baseline (Visit 2) - approximately 1 day
Secondary 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. Baseline (Visit 2) - approximately 1 day
Secondary 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. Visit 3 (approximately 1 month)
Secondary 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. Visit 3 (approximately 1 month)
Secondary 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. Visit 4 (approximately 3 months)
Secondary 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. Visit 4 (approximately 3 months)
Secondary 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. Visit 1 through the end of the study (approximately 4 months)
Secondary 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. Visit 1 through the end of the study (approximately 4 months)
Secondary 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 Visit 1 through the end of the study (approximately 4 months)
See also
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Completed NCT05055024 - An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy Phase 2
Suspended NCT04419792 - 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
Completed NCT02221869 - A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy Phase 3
Completed NCT03030599 - A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy Phase 3
Active, not recruiting NCT02611687 - Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period Phase 3
Completed NCT04306952 - Awareness and Self-Compassion Enhancing Narcolepsy Treatment N/A
Not yet recruiting NCT06383806 - Decreasing Nightmares in Adults With Narcolepsy N/A
Not yet recruiting NCT05914194 - A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1 Phase 3
Completed NCT02637076 - Xyrem and Brain Dopamine in Narcolepsy Phase 4
Completed NCT05709873 - Narcolepsy Nightmare Study N/A
Completed NCT01800045 - Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP) Phase 3
No longer available NCT03433131 - Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy

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