drugset / Trial / NCT06358950
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.
Timeline
- Start
- 2024-03-24
- Primary completion
- 2025-06-19
- Completion
- 2025-07-31
Outcome
Met primary endpoint
release “In Vibrance-1, alixorexton met the primary endpoint across all doses tested” alkermes.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALKS 2680 | Unknown | 4 mg | Oral |
| Subject | ALKS 2680 | Unknown | 6 mg | Oral |
| Subject | ALKS 2680 | Unknown | 8 mg | Oral |