Trials / Recruiting
RecruitingNCT06767683
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 256 (estimated)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALKS 2680, 4mg | Oral tablet containing 4 mg of ALKS 2680 for once daily administration |
| DRUG | ALKS 2680, 6mg | Oral tablet containing 6 mg of ALKS 2680 for once daily administration |
| DRUG | ALKS 2680, 8mg | Oral tablet containing 8 mg of ALKS 2680 for once daily administration |
| DRUG | ALKS 2680, 10mg | Oral tablet containing 10 mg of ALKS 2680 for once daily administration |
| DRUG | ALKS 2680, 14mg | Oral tablet containing 14 mg of ALKS 2680 for once daily administration |
| DRUG | ALKS 2680, 18mg | Oral tablet containing 18 mg of ALKS 2680 for once daily administration |
Timeline
- Start date
- 2025-01-27
- Primary completion
- 2028-06-01
- Completion
- 2028-06-01
- First posted
- 2025-01-10
- Last updated
- 2026-03-04
Locations
46 sites across 8 countries: United States, Australia, Belgium, Czechia, France, Italy, Netherlands, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06767683. Inclusion in this directory is not an endorsement.