drugset / Trial / NCT05101122
Study for Efficacy and Dose Escalation of AD313 + Atomoxetine (SEED)
Non-randomizedSequentialOpen-labelTreatment
Summary
The SEED study is designed to assess the safety and efficacy for Obstructive Sleep Apnea (OSA) of 3 escalating dose combinations of atomoxetine with AD313 compared to baseline and to atomoxetine alone.
Timeline
- Start
- 2021-10-19
- Primary completion
- 2022-04-18
- Completion
- 2022-04-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Atomoxetine | Other / unclassified | 40 mg | Oral |
| Comparator | Atomoxetine | Other / unclassified | 80 mg | Oral |
| Subject | Dronabinol | Other / unclassified | 2.5 mg | Oral |
| Subject | Dronabinol | Other / unclassified | 5 mg | Oral |
| Subject | Dronabinol | Other / unclassified | 10 mg | Oral |