Trials / Completed
CompletedNCT06358950
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)
A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 1
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALKS 2680 | Oral tablet of ALKS 2680 for once daily administration |
| DRUG | Placebo | Oral tablet containing matching placebo for once daily administration |
Timeline
- Start date
- 2024-03-28
- Primary completion
- 2025-06-19
- Completion
- 2025-07-31
- First posted
- 2024-04-11
- Last updated
- 2025-10-14
Locations
45 sites across 8 countries: United States, Australia, Belgium, Czechia, France, Italy, Netherlands, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06358950. Inclusion in this directory is not an endorsement.