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NCT05687903 · ClinicalTrials.gov registry record · Phase 2

A Study of TAK-861 in Participants With Narcolepsy Type 1

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

Completed
Registry status
Phase 2
Development phase
112
Enrollment target
20
Study locations

NCT05687903 is a Phase 2 study of Narcolepsy Type 1 that has completed, run by Takeda. The registered enrollment target is 112 participants, below the 174-participant average among 6 other Narcolepsy Type 1 trials with a reported enrollment target (36% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT05687903, a Phase 2 study of Narcolepsy Type 1, has completed, sponsored by Takeda.

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

Study Summary

The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in the study across North America, Europe and Asia Pacific. The treatment (TAK-861 or placebo) will be administered for 8 or 12 weeks. After this treatment period the participant will have the option to participate in a separate, long- term extension study during which all participants will be treated with TAK-861.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG TAK-861

Study Locations (20)

Ohio

  • Intrepid Research - Cincinnati
  • The Cleveland Clinic Foundation - Cleveland
  • Ohio Sleep Medicine Institute - Dublin

California

  • Stanford Center for Sleep Sciences and Medicine - Redwood City
  • SDS Clinical Trials, Inc. - Santa Ana

Georgia

  • Neurotrials Research - Atlanta
  • Georgia Neuro Center - Gainesville

North Carolina

  • Research Carolina Elite - Denver
  • ARSM Research, LLC - Huntersville

South Carolina

  • Medical University of South Carolina - PPDS - Charleston
  • Bogan Sleep Consultants, LLC - Columbia

Texas

  • Comprehensive Sleep Medicine Associates - Sugar Land - Houston
  • Sleep Therapy and Research Center - San Antonio

Alabama

  • Sleep Disorders Center of Alabama - Birmingham

Colorado

  • Delta Waves LLC - Hunt - PPDS, Sleep Disorder and Research Center - Colorado Springs

Trial Details

FieldValue
Enrollment Target 112 participants
Start Date 2023-01-09
Est. Completion 2023-12-14
Phase Phase 2

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT05687903

The ClinicalTrials.gov registry entry for NCT05687903 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 174-participant average among 6 other Narcolepsy Type 1 trials with a reported enrollment target (36% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

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.

NCT05687903 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Ohio, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT05687903 about?

NCT05687903 is a clinical study titled "A Study of TAK-861 in Participants With Narcolepsy Type 1". The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in the study across North America, Europe and Asia Pacific. The treatment (TAK-861 or placebo) will be administered f...

What is the current status of trial NCT05687903?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2023-01-09. Estimated completion is 2023-12-14.

What conditions does trial NCT05687903 study?

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

What interventions are being tested in trial NCT05687903?

The interventions under investigation include: Placebo (DRUG), TAK-861 (DRUG).

Who is sponsoring clinical trial NCT05687903?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05687903 being conducted?

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

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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.