A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Condition(s) studied
Investigational drug(s) / intervention(s)
TAK-861: TAK-861 tablets
Placebo: TAK-861-matching placebo tablets
Study summary
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.
Eligibility
Primary outcome measure(s)
- Time to Loss of Response in the Epworth Sleepiness Scale (ESS) Score During the Up to 4-Week RW Period — Up to 4-week RW period
The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within normal range.
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| Takeda Site 15 | Redwood City | California | |
| Takeda Site 19 | Brandon | Florida | |
| Takeda Site 22 | Miami | Florida | |
| Takeda Site 23 | Southfield | Michigan | |
| Takeda Site 20 | Middletown | New Jersey | |
| Takeda Site 24 | Durham | North Carolina | |
| Takeda Site 25 | Winston-Salem | North Carolina | |
| Takeda Site 16 | Cincinnati | Ohio | |
| Takeda Site 18 | Cleveland | Ohio | |
| Takeda Site 17 | Columbia | South Carolina | |
| Takeda Site 21 | Austin | Texas | |
| Takeda Site 1 | Montpellier | France | |
| Takeda Site 2 | Paris | France | |
| Takeda Site 3 | Toulouse | France | |
| Takeda Site 4 | Schwerin | Mecklenburg-Vorpommern | |
| Takeda Site 5 | Berlin | Germany | |
| Takeda Site 6 | Bologna | Emilia-Romagna | |
| Takeda Site 7 | Rome | Lazio | |
| Takeda Site 8 | Heemstede | Netherlands | |
| Takeda Site 12 | Vitoria-Gasteiz | Alava | |
| Takeda Site 11 | Alzira | Valencia | |
| Takeda Site 10 | Barcelona | Spain | |
| Takeda Site 9 | Madrid | Spain | |
| Takeda Site 13 | Barmelweid | Canton of Aargau | |
| Takeda Site 14 | Bern | Switzerland |
More Takeda trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07363720 on ClinicalTrials.gov ↗ ← All trials in Italy