RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)

Korábbi kezelés

• Current use of stimulant or wake-promoting medications, unless a washout is permitted
• Regular use of prescribed hypnotics for sleep (≥3 times per week); washout period is permitted.
  • 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 and CYP2C19. To assess for drug interactions, investigators should use the Lexicomp Drug Interactions 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 a case-by-case basis.
  • If the search yields "A" - No Known Interaction or "B" - No Action Needed, then proceed to screen/include the potential participant.
• Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days
• Current use of dopaminergic drugs

Más betegség

• Poorly controlled hypertension (systolic blood pressure ≥140 or diastolic blood pressure ≥90 mmHg)
• Moderate to severe hepatic impairment (ie, Child-Pugh class B or C)\*
• Recent myocardial infarction (\<1 year), unstable angina, serious cardiac arrhythmias, or other serious heart problems, at the discretion of the investigator

Egyéb

• 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
• Known estimated glomerular filtration rate \<30 mL/min/1.73 m2 and/or chronic dialysis\*
• Known severe left ventricular hypertrophy, mitral valve prolapse
  • SOLRIAMFETOL EXCLUSION CRITERIA

• See NCT06404086 for RECOVER-SLEEP: Platform Protocol level inclusion criteria which applies to this appendix