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CompletedNCT00345800Updated Apr 8, 2022Results posted

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

A Phase 1 interventional study of Sodium Oxybate (Xyrem) in Narcolepsy With Cataplexy, sponsored by UCB Pharma SA. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-04-08.

Sponsored by UCB Pharma SA (part of UCB S.A.) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Narcolepsy With Cataplexy

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Keywords

  • Endocrine Evaluation cataplexy
  • sodium oxybate (xyrem)
03

In context

Narcolepsy

157 studies on the registry are indexed under Narcolepsy; 37 are open to participants now.

This study's enrollment of 25 is below the median of 78 across 114 interventional studies indexed under Narcolepsy.

Browse Narcolepsy studies →

Lead sponsor

UCB Pharma SA is the lead sponsor of 28 studies on the registry; none are open to participants now.

Browse UCB Pharma studies →All UCB S.A. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

Inclusion Criteria:

  • Narcoleptic patients with cataplexy

Exclusion Criteria:

  • Subjects not diagnosed with narcolepsy with cataplexy

Exclusion Criteria:

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • 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)

Interventions

  • DrugSodium 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

    Also known as: Xyrem

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (Visit 2) - approximately 1 day

  2. 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.

    Time frame: After 1 month of treatment (Visit 3)

  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.

    Time frame: After 3 months of treatment (Visit 4)

Secondary outcomes

  1. 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.

    Time frame: Baseline (Visit 2) - approximately 1 day

  2. 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.

    Time frame: Visit 3 (approximately 1 month)

  3. 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.

    Time frame: Visit 4 (approximately 3 months)

  4. 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.

    Time frame: Baseline (Visit 2) - approximately 1 day

  5. 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.

    Time frame: Visit 3 (approximately 1 month)

  6. 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.

    Time frame: Visit 4 (approximately 3 months)

  7. 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.

    Time frame: Baseline (Visit 2) - approximately 1 day

  8. 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.

    Time frame: Visit 3 (approximately 1 month)

  9. 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.

    Time frame: Visit 4 (approximately 3 months)

  10. 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.

    Time frame: Baseline (Visit 2) - approximately 1 day

  11. 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.

    Time frame: Visit 3 (approximately 1 month)

  12. 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.

    Time frame: Visit 4 (approximately 3 months)

  13. 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.

    Time frame: Baseline (Visit 2) - approximately 1 day

  14. 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.

    Time frame: Visit 3 (approximately 1 month)

  15. 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.

    Time frame: Visit 4 (approximately 3 months)

  16. 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.

    Time frame: Baseline (Visit 2) - approximately 1 day

  17. 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.

    Time frame: Visit 3 (approximately 1 month)

  18. 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.

    Time frame: Visit 4 (approximately 3 months)

  19. 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.

    Time frame: Baseline (Visit 2) - approximately 1 day

  20. 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.

    Time frame: Visit 3 (approximately 1 month)

  21. 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.

    Time frame: Visit 4 (approximately 3 months)

  22. 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.

    Time frame: Baseline (Visit 2) - approximately 1 day

  23. 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.

    Time frame: Visit 3 (approximately 1 month)

  24. 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.

    Time frame: Visit 4 (approximately 3 months)

  25. 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.

    Time frame: Baseline (Visit 2) - approximately 1 day

  26. 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.

    Time frame: Baseline (Visit 2) - approximately 1 day

  27. 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.

    Time frame: Visit 3 (approximately 1 month)

  28. 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.

    Time frame: Visit 3 (approximately 1 month)

  29. 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.

    Time frame: Visit 4 (approximately 3 months)

  30. 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.

    Time frame: Visit 4 (approximately 3 months)

  31. 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.

    Time frame: Visit 1 through the end of the study (approximately 4 months)

  32. 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.

    Time frame: Visit 1 through the end of the study (approximately 4 months)

  33. 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

    Time frame: Visit 1 through the end of the study (approximately 4 months)

07

Results

Posted Apr 8, 2022

Participant flow

This single-center, therapeutic, exploratory study started to enroll subjects in April 2006.

Participant flow — Overall Study
MilestoneSodium Oxybate
Started25
Completed25
Not completed0

Outcome measures

PrimaryThe 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.

Time frame:
Baseline (Visit 2) - approximately 1 day
Reported as:
Mean · ng/mL
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2)
ng/mLSodium Oxybate
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2)207.4 ± 86.5
PrimaryThe 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.

Time frame:
After 1 month of treatment (Visit 3)
Reported as:
Mean · ng/mL
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3)
ng/mLSodium Oxybate
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3)200.4 ± 77.7
PrimaryThe 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.

Time frame:
After 3 months of treatment (Visit 4)
Reported as:
Mean · ng/mL
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4)
ng/mLSodium Oxybate
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4)210.2 ± 90.3
SecondaryThe 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.

Time frame:
Baseline (Visit 2) - approximately 1 day
Reported as:
Mean · ng/mL
The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2)
ng/mLSodium Oxybate
Bed time1.821 ± 4.844
1h1.225 ± 2.895
2h1.408 ± 1.656
4h1.236 ± 1.904
8h0.576 ± 0.632
12h0.293 ± 0.310
16h0.309 ± 0.282
20h0.313 ± 0.362
SecondaryThe 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.

Time frame:
Visit 3 (approximately 1 month)
Reported as:
Mean · ng/mL
The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3
ng/mLSodium Oxybate
Pre-dose2.432 ± 7.118
1h5.914 ± 9.743
2h5.238 ± 8.557
4h3.018 ± 4.332
8h0.256 ± 0.326
12h0.308 ± 0.664
16h0.460 ± 0.767
20h0.306 ± 0.342
SecondaryThe 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.

Time frame:
Visit 4 (approximately 3 months)
Reported as:
Mean · ng/mL
The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4
ng/mLSodium Oxybate
Pre-dose0.816 ± 1.372
1h3.804 ± 3.173
2h3.864 ± 5.731
4h2.712 ± 3.178
8h0.224 ± 0.292
12h0.420 ± 1.355
16h0.296 ± 0.491
20h0.244 ± 0.390
SecondaryCortisol 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.

Time frame:
Baseline (Visit 2) - approximately 1 day
Reported as:
Mean · ug/L
Cortisol Measured at Baseline (Visit 2)
ug/LSodium Oxybate
Bed time42.21 ± 28.53
1h27.91 ± 17.09
2h22.80 ± 14.54
4h36.06 ± 28.46
8h115.79 ± 52.33
12h143.39 ± 70.67
16h90.84 ± 34.83
20h68.48 ± 40.77
SecondaryCortisol 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.

Time frame:
Visit 3 (approximately 1 month)
Reported as:
Mean · ug/L
Cortisol Measured at Visit 3
ug/LSodium Oxybate
Pre-dose35.84 ± 27.83
1h24.75 ± 18.20
2h34.62 ± 31.93
4h44.28 ± 36.64
8h95.61 ± 57.14
12h130.21 ± 61.28
16h77.33 ± 32.93
20h70.49 ± 33.71
SecondaryCortisol 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.

Time frame:
Visit 4 (approximately 3 months)
Reported as:
Mean · ug/L
Cortisol Measured at Visit 4
ug/LSodium Oxybate
Pre-dose34.46 ± 24.85
1h25.61 ± 19.06
2h30.06 ± 24.40
4h45.27 ± 35.65
8h113.84 ± 71.18
12h146.33 ± 64.42
16h92.48 ± 30.94
20h75.55 ± 38.01
SecondaryThe 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.

Time frame:
Baseline (Visit 2) - approximately 1 day
Reported as:
Mean · pg/mL
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2)
pg/mLSodium Oxybate
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2)65.6 ± 46.7
SecondaryThe 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.

Time frame:
Visit 3 (approximately 1 month)
Reported as:
Mean · pg/mL
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 3
pg/mLSodium Oxybate
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 362.8 ± 37.9
SecondaryThe 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.

Time frame:
Visit 4 (approximately 3 months)
Reported as:
Mean · pg/mL
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 4
pg/mLSodium Oxybate
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 454.8 ± 27.3
SecondaryThe 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.

Time frame:
Baseline (Visit 2) - approximately 1 day
Reported as:
Mean · ug/L
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Baseline (Visit 2)
ug/LSodium Oxybate
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Baseline (Visit 2)1988.2 ± 1283.3
SecondaryThe 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.

Time frame:
Visit 3 (approximately 1 month)
Reported as:
Mean · ug/L
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 3
ug/LSodium Oxybate
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 32200.9 ± 1517.5
SecondaryThe 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.

Time frame:
Visit 4 (approximately 3 months)
Reported as:
Mean · ug/L
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 4
ug/LSodium Oxybate
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 42130.7 ± 1450.4
SecondaryThe 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.

Time frame:
Baseline (Visit 2) - approximately 1 day
Reported as:
Mean · mUI/L
The Prolactin Measured in Fasting Conditions at Baseline (Visit 2)
mUI/LSodium Oxybate
The Prolactin Measured in Fasting Conditions at Baseline (Visit 2)356.8 ± 185.9
SecondaryThe Prolactin Measured in Fasting Conditions at Visit 3

An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 3.

Time frame:
Visit 3 (approximately 1 month)
Reported as:
Mean · mUI/L
The Prolactin Measured in Fasting Conditions at Visit 3
mUI/LSodium Oxybate
The Prolactin Measured in Fasting Conditions at Visit 3280.0 ± 162.8
SecondaryThe Prolactin Measured in Fasting Conditions at Visit 4

An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 4.

Time frame:
Visit 4 (approximately 3 months)
Reported as:
Mean · mUI/L
The Prolactin Measured in Fasting Conditions at Visit 4
mUI/LSodium Oxybate
The Prolactin Measured in Fasting Conditions at Visit 4258.4 ± 113.6
SecondaryThe 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.

Time frame:
Baseline (Visit 2) - approximately 1 day
Reported as:
Mean · uU/mL
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Baseline (Visit 2)
uU/mLSodium Oxybate
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Baseline (Visit 2)1.366 ± 0.622
SecondaryThe 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.

Time frame:
Visit 3 (approximately 1 month)
Reported as:
Mean · uU/mL
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 3
uU/mLSodium Oxybate
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 31.292 ± 0.599
SecondaryThe 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.

Time frame:
Visit 4 (approximately 3 months)
Reported as:
Mean · uU/mL
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 4
uU/mLSodium Oxybate
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 41.425 ± 0.818
SecondaryThe 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.

Time frame:
Baseline (Visit 2) - approximately 1 day
Reported as:
Mean · pg/mL
The Total Thyroxin (T4) Measured in Fasting Conditions at Baseline (Visit 2)
pg/mLSodium Oxybate
The Total Thyroxin (T4) Measured in Fasting Conditions at Baseline (Visit 2)11.34 ± 1.68
SecondaryThe 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.

Time frame:
Visit 3 (approximately 1 month)
Reported as:
Mean · pg/mL
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 3
pg/mLSodium Oxybate
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 311.47 ± 2.10
SecondaryThe 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.

Time frame:
Visit 4 (approximately 3 months)
Reported as:
Mean · pg/mL
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 4
pg/mLSodium Oxybate
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 411.65 ± 1.78
SecondaryThe 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.

Time frame:
Baseline (Visit 2) - approximately 1 day
Reported as:
Mean · mosm/kg
The Osmolality Measured in Fasting Conditions at Baseline (Visit 2)
mosm/kgSodium Oxybate
The Osmolality Measured in Fasting Conditions at Baseline (Visit 2)291.6 ± 4.5
SecondaryThe Osmolality Measured in Fasting Conditions at Visit 3

An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 3.

Time frame:
Visit 3 (approximately 1 month)
Reported as:
Mean · mosm/kg
The Osmolality Measured in Fasting Conditions at Visit 3
mosm/kgSodium Oxybate
The Osmolality Measured in Fasting Conditions at Visit 3292.2 ± 4.9
SecondaryThe Osmolality Measured in Fasting Conditions at Visit 4

An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 4.

Time frame:
Visit 4 (approximately 3 months)
Reported as:
Mean · mosm/kg
The Osmolality Measured in Fasting Conditions at Visit 4
mosm/kgSodium Oxybate
The Osmolality Measured in Fasting Conditions at Visit 4292.1 ± 5.5
SecondaryElectrolytes (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.

Time frame:
Baseline (Visit 2) - approximately 1 day
Reported as:
Mean · mmol/L
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Baseline (Visit 2)
mmol/LSodium Oxybate
Na (Sodium in mmol/L)141.4 ± 1.9
K (Potassium in mmol/L)3.88 ± 0.21
Ca (Calcium in mmol/L)2.257 ± 0.084
SecondaryThe 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.

Time frame:
Baseline (Visit 2) - approximately 1 day
Reported as:
Mean · mg/L
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Baseline (Visit 2)
mg/LSodium Oxybate
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Baseline (Visit 2)34.4 ± 6.0
SecondaryElectrolytes (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.

Time frame:
Visit 3 (approximately 1 month)
Reported as:
Mean · mmol/L
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 3
mmol/LSodium Oxybate
Na (Sodium in mmol/L)141.9 ± 2.1
K (Potassium in mmol/L)3.90 ± 0.25
Ca (Calcium in mmol/L)2.334 ± 0.071
SecondaryThe 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.

Time frame:
Visit 3 (approximately 1 month)
Reported as:
Mean · mg/L
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 3
mg/LSodium Oxybate
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 334.2 ± 4.5
SecondaryElectrolytes (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.

Time frame:
Visit 4 (approximately 3 months)
Reported as:
Mean · mmol/L
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 4
mmol/LSodium Oxybate
Na (Sodium in mmol/L)141.2 ± 1.9
K (Potassium in mmol/L)3.80 ± 0.27
Ca (Calcium in mmol/L)2.290 ± 0.063
SecondaryThe 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.

Time frame:
Visit 4 (approximately 3 months)
Reported as:
Mean · mg/L
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 4
mg/LSodium Oxybate
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 435.0 ± 3.5
SecondaryThe 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.

Time frame:
Visit 1 through the end of the study (approximately 4 months)
Reported as:
Number · Participants
The Number of Patients Reporting at Least One Adverse Event (AE) During the Course of the Study
ParticipantsSodium Oxybate
The Number of Patients Reporting at Least One Adverse Event (AE) During the Course of the Study20
SecondaryThe 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.

Time frame:
Visit 1 through the end of the study (approximately 4 months)
Reported as:
Number · Participants
The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study
ParticipantsSodium Oxybate
The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study1
SecondaryThe 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

Time frame:
Visit 1 through the end of the study (approximately 4 months)
Reported as:
Number · Participants
The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study
ParticipantsSodium Oxybate
The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study1

Adverse events

Collected over Adverse Events were collected from Visit 1 through the end of the study (approximately 4 months).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sodium Oxybate0/25 (0%)1/25 (4%)15/25 (60%)
Most frequent serious events
Most frequent serious events
EventSodium Oxybate
Rectal haemorrhageGastrointestinal disorders1/25
Most frequent other events
Most frequent other events
EventSodium Oxybate
HeadacheNervous system disorders6/25
NauseaGastrointestinal disorders5/25
Abdominal pain upperGastrointestinal disorders3/25
DiarrhoeaGastrointestinal disorders2/25
ArthralgiaMusculoskeletal and connective tissue disorders2/25
OsteoarthritisMusculoskeletal and connective tissue disorders2/25
DizzinessNervous system disorders2/25
AnxietyPsychiatric disorders2/25
CoughRespiratory, thoracic and mediastinal disorders2/25
HyperhidrosisSkin and subcutaneous tissue disorders2/25

Baseline characteristics

Baseline Characteristics refer to the Intention-to-Treat (ITT) population consisting of the 25 subjects enrolled in the study who took at least 1 dose of study medication.

Age, Categorical
Age, Categorical(Participants)Sodium Oxybate
<=18 years1
Between 18 and 65 years23
>=65 years1
Age, Continuous
Age, Continuous(years)Sodium Oxybate
Mean38.99 ± 13.94
Sex: Female, Male
Sex: Female, Male(Participants)Sodium Oxybate
Female12
Male13
08

Study locations

1 site
  • Liège, Belgium
09

References and documents

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2006 to primary completion in Jan 2008, 21 months.

Results were first posted in Apr 2022, 14 years 2 months after primary completion.

Of 13 phase 1 interventional studies under Narcolepsy, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 11. This study's 21 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 28, 2006
First posted
Jun 29, 2006
StartActual
Apr 10, 2006
Primary completionActual
Jan 22, 2008
CompletionActual
Jan 22, 2008
Results first posted
Apr 8, 2022
Last update
Apr 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00345800
Lead sponsor
UCB Pharma SA
Responsible party
Sponsor
First posted
Jun 29, 2006
Start date
Apr 10, 2006
Primary completion
Jan 22, 2008
Completion
Jan 22, 2008
Results posted
Apr 8, 2022
Last update
Apr 8, 2022

Study contacts

UCB Cares
study director · +1 844 599 2273 (UCB)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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