Phase
Condition
Insomnia
Sleep Disorders
Treatment
Modafinil
Modafinil Placebo
Solriamfetol Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
• See NCT06404086 for RECOVER-SLEEP: Platform Protocol level inclusion criteria which applies to this appendix
Exclusion
Exclusion Criteria:
• See NCT06404086 for RECOVER-SLEEP: Platform Protocol level exclusion criteria which applies to this appendix (or sub-study)
Additional Appendix A (Hypersomnia) Level Exclusion Criteria:
Self-reported sleep duration <6 hours per night
Poorly controlled hypertension (systolic blood pressure ≥140 or diastolic bloodpressure ≥90 mmHg)
Moderate to severe hepatic impairment (ie, Child-Pugh class B or C)*
Known estimated glomerular filtration rate <30 mL/min/1.73 m2 and/or chronicdialysis*
Recent myocardial infarction (<1 year), unstable angina, serious cardiacarrhythmias, or other serious heart problems, at the discretion of the investigator
Current use of stimulant or wake-promoting medications, unless a washout ispermitted
Regular use of prescribed hypnotics for sleep (≥3 times per week); washout period ispermitted.
- characterized by the screening labs: coagulation panel and CMP w/LFTs
MODAFINIL EXCLUSION CRITERIA
- Modafinil can affect drug metabolism given its effect on enzymes such as CYP3A4 andCYP2C19. To assess for drug interactions, investigators should use the Lexicomp DrugInteractions System that is available at most institutions. o If the search yields "D" - Consider Modifying Therapy or "X" - Avoid Combination,then the ACTION is to exclude the potential participant. An important example of this is steroid hormonal contraceptives.
If the search yields "C" - Monitor Therapy, then discuss with site PIs on acase-by-case basis.
If the search yields "A" - No Known Interaction or "B" - No Action Needed, thenproceed to screen/include the potential participant.
- Known severe left ventricular hypertrophy, mitral valve prolapse
SOLRIAMFETOL EXCLUSION CRITERIA
Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOIwithin the preceding 14 days
Current use of dopaminergic drugs
Study Design
Study Description
Connect with a study center
All sites listed under NCT06404086
Durham, North Carolina 27710
United StatesActive - Recruiting
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