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NCT06767683 · ClinicalTrials.gov registry record · Phase 2
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
A Phase 2 study of Idiopathic Hypersomnia and Narcolepsy Type 1, sponsored by Alkermes.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 256
- Enrollment target
- 20
- Study locations
NCT06767683: Recruiting Phase 2 study of Idiopathic Hypersomnia and Narcolepsy Type 1, sponsored by Alkermes.
NCT06767683 is a Phase 2 study of Idiopathic Hypersomnia and Narcolepsy Type 1 that is actively recruiting participants, run by Alkermes. The registered enrollment target is 256 participants, above the 85-participant average among 7 other Idiopathic Hypersomnia trials with a reported enrollment target (201% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06767683, a Phase 2 study of Idiopathic Hypersomnia and Narcolepsy Type 1, is actively recruiting participants, sponsored by Alkermes.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 256 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG ALKS 2680, 4mg
- DRUG ALKS 2680, 6mg
- DRUG ALKS 2680, 8mg
- DRUG ALKS 2680, 10mg
- DRUG ALKS 2680, 14mg
Study Locations (20)
California
- Alkermes Investigational Site - Los Angeles
- Alkermes Investigator Site - San Francisco
- Alkermes Investigational Site - Stanford
Florida
- Alkermes Investigational Site - Brandon
- Alkermes Investigational Site - Miami
- Alkermes Investigational Site - Winter Park
Georgia
- Alkermes Investigational Site - Atlanta
- Alkermes Investigational Site - Macon
- Alkermes Investigational Site - Stockbridge
Michigan
- Alkermes Investigational Site - Lansing
- Alkermes Investigational Site - Sterling Heights
North Carolina
- Alkermes Investigational Site - Denver
- Alkermes Investigational Site - Huntersville
Arizona
- Alkermes Investigator Site - Phoenix
Arkansas
- Alkermes Investigational Site - Little Rock
Colorado
- Alkermes Investigational Site - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2025-01-27 |
| Est. Completion | 2028-06 |
| Phase | Phase 2 |
What NCT06767683 shows while recruiting
NCT06767683 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, above the 85-participant average among 7 other Idiopathic Hypersomnia trials with a reported enrollment target (201% higher).
The record links to 3 conditions, with Idiopathic Hypersomnia appearing as the primary indexed condition, and to 5 interventions - of which ALKS 2680, 4mg is the first listed.
NCT06767683 names 20 study sites across 12 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT06767683 about?
NCT06767683 is a clinical study titled "A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia". 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.
What is the current status of trial NCT06767683?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 256 participants. The study started on 2025-01-27. Estimated completion is 2028-06.
What conditions does trial NCT06767683 study?
This clinical trial studies the following conditions: Idiopathic Hypersomnia, Narcolepsy Type 1, Narcolepsy Type 2.
What interventions are being tested in trial NCT06767683?
The interventions under investigation include: ALKS 2680, 4mg (DRUG), ALKS 2680, 6mg (DRUG), ALKS 2680, 8mg (DRUG), ALKS 2680, 10mg (DRUG), ALKS 2680, 14mg (DRUG).
Who is sponsoring clinical trial NCT06767683?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06767683 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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