Phase 1
N=25
Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
Narcolepsy With Cataplexy
Bottom Line
View on ClinicalTrials.gov: NCT00345800 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Apr 2022
Primary outcome: Primary: The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2) — 207.4 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Sodium Oxybate (Xyrem) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Pharma SA
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2) |
207.4 | — |
| PRIMARY The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3) |
200.4 | — |
| PRIMARY The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4) |
210.2 | — |
| SECONDARY The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2) |
1.821; 1.225; 1.408; 1.236; 0.576; 0.293 | — |
| SECONDARY The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3 |
2.432; 5.914; 5.238; 3.018; 0.256; 0.308 | — |
| SECONDARY The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4 |
0.816; 3.804; 3.864; 2.712; 0.224; 0.420 | — |
| SECONDARY Cortisol Measured at Baseline (Visit 2) |
42.21; 27.91; 22.80; 36.06; 115.79; 143.39 | — |
| SECONDARY Cortisol Measured at Visit 3 |
35.84; 24.75; 34.62; 44.28; 95.61; 130.21 | — |
| SECONDARY Cortisol Measured at Visit 4 |
34.46; 25.61; 30.06; 45.27; 113.84; 146.33 | — |
| SECONDARY The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2) |
65.6 | — |
| SECONDARY The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 3 |
62.8 | — |
| SECONDARY The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 4 |
54.8 | — |
| SECONDARY The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Baseline (Visit 2) |
1988.2 | — |
| SECONDARY The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 3 |
2200.9 | — |
| SECONDARY The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 4 |
2130.7 | — |
| SECONDARY The Prolactin Measured in Fasting Conditions at Baseline (Visit 2) |
356.8 | — |
| SECONDARY The Prolactin Measured in Fasting Conditions at Visit 3 |
280.0 | — |
| SECONDARY The Prolactin Measured in Fasting Conditions at Visit 4 |
258.4 | — |
| SECONDARY The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Baseline (Visit 2) |
1.366 | — |
| SECONDARY The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 3 |
1.292 | — |
| SECONDARY The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 4 |
1.425 | — |
| SECONDARY The Total Thyroxin (T4) Measured in Fasting Conditions at Baseline (Visit 2) |
11.34 | — |
| SECONDARY The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 3 |
11.47 | — |
| SECONDARY The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 4 |
11.65 | — |
| SECONDARY The Osmolality Measured in Fasting Conditions at Baseline (Visit 2) |
291.6 | — |
| SECONDARY The Osmolality Measured in Fasting Conditions at Visit 3 |
292.2 | — |
| SECONDARY The Osmolality Measured in Fasting Conditions at Visit 4 |
292.1 | — |
| SECONDARY Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Baseline (Visit 2) |
141.4; 3.88; 2.257 | — |
| SECONDARY The Electrolyte Phosphate (P) Measured in Fasting Conditions at Baseline (Visit 2) |
34.4 | — |
| SECONDARY Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 3 |
141.9; 3.90; 2.334 | — |
| SECONDARY The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 3 |
34.2 | — |
| SECONDARY Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 4 |
141.2; 3.80; 2.290 | — |
| SECONDARY The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 4 |
35.0 | — |
| SECONDARY The Number of Patients Reporting at Least One Adverse Event (AE) During the Course of the Study |
20 | — |
| SECONDARY The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study |
1 | — |
| SECONDARY The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study |
1 | — |
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.
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria
- Narcoleptic patients with cataplexy
Exclusion Criteria
- Subjects not diagnosed with narcolepsy with cataplexy
Exclusion Criteria
Data sourced from ClinicalTrials.gov (NCT00345800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.