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NCT07363720

A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy

StatusActive, Not Recruiting
PhasePhase 3
SponsorTakeda
Primary completion (estimated)

At risk: Primary completion moved at least 2 months later.

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Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 10 words
    • Primary and study completion pushed from Oct 2, 2026 to Dec 17, 2026
    • Secondary endpoints: details revised at 6 of 8 entries
    • Study description expanded, about 2 words
  2. Enrollment closed, study ongoing
    • Final enrollment: 98 participants (planned 88)
    • Site details revised at 25 of 25 sites
    v5
  3. Trial sites expanded: 18 → 25 locationsv4
  4. Trial sites expanded: 7 → 18 locationsv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 7
    • Start date changed from estimate of Jan 30, 2026 to Jan 29, 2026
    v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Time to Loss of Response in the Epworth Sleepiness Scale (ESS) Score During the Up to 4-Week RW Period
Timeframe: Up to 4-week RW period

Secondary (8)

Change From the End of the OL Treatment Period to Week 2 of the RW Period on the Maintenance of Wakefulness Test (MWT)
Weekly Cataplexy Rate (WCR) at Week 2 of the RW Period
Change from the End of the OL Treatment Period to Week 2 of the RW Period in Mean Number of Lapses on the Psychomotor Vigilance Test (PVT)
Number of Participants Reporting Much or Very Much Worse in Patient Global Impression of Change (PGI-C) Score at Week 2 of the RW Period
Change from the End of the OL Treatment Period to Week 2 of the RW Period in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score
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Change from the End of the OL Treatment Period to Week 2 of the RW Period in Functional Impacts of Narcolepsy Instrument (FINI) Domain Scores
Change from the End of the OL Treatment Period to Week 2 of the RW Period in Number of Correct Responses on the International Digit Symbol Substitution Test-symbols (iDSST-s)
Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE)

Arms and interventions

Double-blind RW Period: TAK-861Experimental

Participants on stable TAK 861 dose will receive the same dose of TAK-861 they were taking at the end of the OL treatment period, for up to 4 weeks in the double-blind RW period.

Double-blind RW Period: PlaceboPlacebo comparator

Participants will receive TAK-861 matching-placebo, for up to 4 weeks in the double-blind RW period.

Drugs: TAK-861, Placebo

Sites

25 sites in 7 countries

United States 11, Spain 4, France 3, Germany 2, Italy 2, Switzerland 2, Netherlands 1