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NCT06358950 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)

A Phase 2 study of Narcolepsy Type 1, sponsored by Alkermes.

Completed
Registry status
Phase 2
Development phase
92
Enrollment target
20
Study locations

NCT06358950: Completed Phase 2 study of Narcolepsy Type 1, sponsored by Alkermes.

NCT06358950 is a Phase 2 study of Narcolepsy Type 1 that has completed, run by Alkermes. The registered enrollment target is 92 participants, below the 177-participant average among 6 other Narcolepsy Type 1 trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06358950, a Phase 2 study of Narcolepsy Type 1, has completed, sponsored by Alkermes.

COMPLETED
Registry status
Phase 2
Development phase
92 participants
Enrollment target
20
Study locations

Study 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 Studied

Narcolepsy Type 1

Interventions

  • DRUG Placebo
  • DRUG ALKS 2680

Study Locations (20)

California

  • Alkermes Investigational Site - Los Angeles
  • Alkermes Investigational Site - Redwood City
  • Alkermes Investigator Site - San Francisco
  • Alkermes Investigational Site - Santa Ana

Florida

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

Georgia

  • Alkermes Investigational Site - Atlanta
  • Alkermes Investigational Site - Macon
  • Alkermes Investigational Site - Stockbridge

Colorado

  • Alkermes Investigational Site - Aurora
  • Alkermes Investigational Site - Colorado Springs

Michigan

  • Alkermes Investigator Site - Lansing
  • Alkermes Investigator Site - Sterling Heights

North Carolina

  • Alkermes Investigational Site - Denver
  • Alkermes Investigational Site - Huntersville

Illinois

  • Alkermes Investigator Site - Peoria

Nebraska

  • Alkermes Investigator Site - Lincoln

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2024-03-28
Est. Completion 2025-07-31
Phase Phase 2
Alkermes

66 total trials

What the finished NCT06358950 record still lists

NCT06358950 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 177-participant average among 6 other Narcolepsy Type 1 trials with a reported enrollment target (48% lower).

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

NCT06358950 names 20 study sites across 9 states, led by California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT06358950 about?

NCT06358950 is a clinical study titled "A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)". 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...

What is the current status of trial NCT06358950?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2024-03-28. Estimated completion is 2025-07-31.

What conditions does trial NCT06358950 study?

This clinical trial studies the following conditions: Narcolepsy Type 1.

What interventions are being tested in trial NCT06358950?

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

Who is sponsoring clinical trial NCT06358950?

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

Where is trial NCT06358950 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT06358950, the US trial registry maintained by the National Library of Medicine. NCT06358950 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.