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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 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.

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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

Idiopathic Hypersomnia Narcolepsy Type 1 Narcolepsy Type 2

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

FieldValue
Enrollment Target 256 participants
Start Date 2025-01-27
Est. Completion 2028-06
Phase Phase 2

Sponsor

Alkermes

66 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06767683

The ClinicalTrials.gov registry entry for NCT06767683 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 85-participant average among 7 other Idiopathic Hypersomnia trials with a reported enrollment target (201% higher). The listed sponsor is Alkermes, which has 66 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.