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

Conditions

• Narcolepsy Type 1 (NT1)
• Narcolepsy With Cataplexy

Eligibility Criteria

Sex

ALL

Age

16 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• TAK-861 — DRUG
  TAK-861 tablets
• Placebo — DRUG
  TAK-861-matching placebo tablets

Study Details

The main aim of this study is to assess how effective TAK-861 is for treating narcolepsy type 1 and if this effect is maintained over time. Participants will take TAK-861 for a few months and if they meet certain criteria, they will be randomly assigned (by chance, like flipping a coin) to continue taking TAK-861 or take placebo (fake medicine) for up to 4 weeks to see if their narcolepsy symptoms return.

Key Dates

Start date

Jan 29, 2026

Status verified

May 2026

Primary completion

Oct 2, 2026

Completion

Oct 2, 2026

Study Design

Enrollment

88 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Double-blind RW Period: TAK-861
  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.
• Placebo Comparator: Double-blind RW Period: Placebo
  Participants will receive TAK-861 matching-placebo, for up to 4 weeks in the double-blind RW period.

Primary Outcome Measure

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

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (11)

Find similar trials in Redwood City, CA

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