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| Name | Class |
|---|---|
| Avadel | INDUSTRY |
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The main objectives of this study are to determine the treatment preferences of children with narcolepsy type 1 between Extended-release sodium oxybate and Non-extended-release oxybates (Sodium oxybate or a medication with the combination of Calcium, magnesium, potassium, and sodium oxybates). The study will also assess the safety, convenience, and tolerability of Extended-release sodium oxybate. Additionally, the researchers aim to assess how well Extended-release sodium oxybate works in treating narcolepsy type 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended-release sodium oxybate | Experimental | Participants in this arm will take extended-release sodium oxybate |
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| Non-extended-release oxybates | Active Comparator | Participants in this arm will take non-extended-release sodium oxybate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended-release sodium oxybate | Drug | Participants will take Extended-release sodium Oxybate (Lumryz) 4.5-9 g oral suspension in approximately â…“ cup of water orally once a day before bedtime. Dosage of Lumryz will be the same as the equivalent total dose of the Non-Extended-release Oxybate (Xywav or Xyrem) that participants use before starting the study |
| Measure | Description | Time Frame |
|---|---|---|
| Participant preference for selecting the extended vs non-extended release oxybates | Participants will be asked at the end of the study whether participants prefer extended-release sodium oxybate vs sodium oxybate vs calcium, magnesium, potassium and sodium oxybates | Baseline, up to 8-12 weeks through study completion |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Epworth Sleepiness Scales for Children and Adolescents (ESS-CHAD) score | ESS-CHAD is a multi-item questionnaire which asks the participants to rate their chances of falling asleep during various normal daily activities. 4-point Likert scale will be used. The score ranges from 0-24. A higher score means higher chance of falling asleep. | Baseline, up to 8-12 weeks through study completion |
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Inclusion Criteria:
Exclusion Criteria:
Participants who have any of the following conditions will not be included in the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miran Cho | Contact | 650-724-4149 | mirancho@stanford.edu | |
| Mila Trabanino | Contact | milaludi@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Oliver Sum-Ping, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Redwood City | California | 94063 | United States |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D012978 | Sodium Oxybate |
| ID | Term |
|---|---|
| D006885 | Hydroxybutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Non-extended-release oxybates | Drug | Participants will take Non-Extended-release Oxybates (Xyrem oral solution or Xywav oral solution) 4.5-9 g orally per night (divided into two doses, once before bedtime and another dose 2-4 hours later) at the same dose of Xyrem or Xywav that participants use before starting the study will be continued to compare with Extended-release sodium Oxybate (Lumryz) |
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| Number of cataplexy attacks | The study team will ask the participants to report the number of cataplexy attacks as measured by Sleep and Symptoms diary when participants switch to the other intervention. | Baseline, up to 8-12 weeks through study completion |
| Change in Patient Global Impression of Change (PGIc) scale score | The PGIc is a 7-point scale. Participants will be asked to rate their narcolepsy impression since the end of the Stable-Dose Period. The scale is Very much better, Much better, A little better, No change, A little worse, Much worse, and Very much worse. | Baseline, up to 8-12 weeks through study completion |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D009930 |
| Organic Chemicals |
| D006880 | Hydroxy Acids |