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NCT05113745 · ClinicalTrials.gov registry record · Phase 3

A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)

A Phase 3 study, sponsored by Axsome Therapeutics.

Completed
Registry status
Phase 3
Development phase
68
Enrollment target

NCT05113745 is a Phase 3 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 68 participants.

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The verdict

NCT05113745, a Phase 3 study, has completed, sponsored by Axsome Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
68 participants
Enrollment target

Study Summary

This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

Interventions

  • DRUG Placebo
  • DRUG AXS-12 (reboxetine)

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2021-10-20
Est. Completion 2024-11-15
Phase Phase 3

Sponsor

Axsome Therapeutics

28 total trials

What the Registry Record Tells You About NCT05113745

The ClinicalTrials.gov registry entry for NCT05113745 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Axsome Therapeutics, which has 28 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05113745 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05113745 about?

NCT05113745 is a clinical study titled "A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)". This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

What is the current status of trial NCT05113745?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 68 participants. The study started on 2021-10-20. Estimated completion is 2024-11-15.

What interventions are being tested in trial NCT05113745?

The interventions under investigation include: Placebo (DRUG), AXS-12 (reboxetine) (DRUG).

Who is sponsoring clinical trial NCT05113745?

This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.