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COMPLETED Phase 2

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

NCT05687903 · View on ClinicalTrials.gov ↗

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

387 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05687903

The ClinicalTrials.gov registry entry for NCT05687903 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05687903 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Ohio, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05687903?

The interventions under investigation include: Placebo (DRUG), TAK-861 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05687903?

This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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