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NCT06843590 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

A Phase 2 study of Idiopathic Hypersomnia, sponsored by Alkermes.

Recruiting
Registry status
Phase 2
Development phase
96
Enrollment target
20
Study locations

NCT06843590: Recruiting Phase 2 study of Idiopathic Hypersomnia, sponsored by Alkermes.

NCT06843590 is a Phase 2 study of Idiopathic Hypersomnia that is actively recruiting participants, run by Alkermes. The registered enrollment target is 96 participants, below the 108-participant average among 7 other Idiopathic Hypersomnia trials with a reported enrollment target (11% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06843590, a Phase 2 study of Idiopathic Hypersomnia, is actively recruiting participants, sponsored by Alkermes.

RECRUITING
Registry status
Phase 2
Development phase
96 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets

Conditions Studied

Idiopathic Hypersomnia

Interventions

  • DRUG Placebo
  • DRUG ALKS 2680

Study Locations (20)

California

  • Alkermes Investigator Site - Los Angeles
  • Alkermes Investigator Site - Redwood City
  • Alkermes Investigator Site - San Francisco

Florida

  • Alkermes Investigator Site - Brandon
  • Alkermes Investigator Site - Miami
  • Alkermes Investigator Site - Winter Park

Georgia

  • Alkermes Investigator Site - Atlanta
  • Alkermes Investigator Site - Macon
  • Alkermes Investigator Site - Stockbridge

North Carolina

  • Alkermes Investigator Site - Denver
  • Alkermes Investigator Site - Huntersville

Alabama

  • Alkermes Investigator Site - Cullman

Arizona

  • Alkermes Investigator Site - Phoenix

Arkansas

  • Alkermes Investigator Site - Little Rock

Colorado

  • Alkermes Investigator Site - Colorado Springs

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2025-05-22
Est. Completion 2026-06
Phase Phase 2
Alkermes

66 total trials

What NCT06843590 shows while recruiting

NCT06843590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 108-participant average among 7 other Idiopathic Hypersomnia trials with a reported enrollment target (11% lower).

The record links to 1 condition, with Idiopathic Hypersomnia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06843590 names 20 study sites across 13 states, led by California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT06843590 about?

NCT06843590 is a clinical study titled "A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia". The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets

What is the current status of trial NCT06843590?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2025-05-22. Estimated completion is 2026-06.

What conditions does trial NCT06843590 study?

This clinical trial studies the following conditions: Idiopathic Hypersomnia.

What interventions are being tested in trial NCT06843590?

The interventions under investigation include: Placebo (DRUG), ALKS 2680 (DRUG).

Who is sponsoring clinical trial NCT06843590?

This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06843590 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06843590

Source: ClinicalTrials.gov NCT06843590, the US trial registry maintained by the National Library of Medicine. NCT06843590 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.