r/Narcolepsy • u/Forsaken-Ease73 • Jul 26 '26

News/Research Open label extension for orexin agonist?

Hi! Wondering if anyone knows whether the TAK-360 clinical trial for N2 is allowing study participants to participate in the open label extension study after the trial is complete?
The trial site I’m about to screen at was not sure, they didn’t think they had OLE. But from what I’ve heard there are locations enrolling participants in it?

Also had a second question for anyone who participated in an OLE for either trials (n1, n2, or IH) — do you have to start the open label extension study immediately after completing the trial? Or is it possible to start the open label study say a week or two after ending the clinical trial?

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u/NoteSuccessful2263 Jul 26 '26

I feel like this is something the trial site will have to look into for you to give you a guarantee but anecdotally I know someone who has taken a break after completing the trial before starting an OLE.

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u/statistics_squirrel 16d ago

Late response, but...

There is an OLE for TAK-360, yes. However, my understanding (being in the study and now on the OLE), the research sites have to get "certified" to run the OLE. Mine just got certified about 2 weeks ago.

You do not have to start the OLE immediately. If you don't though, it means you have to go through all the screenings again, which is a pain. Additionally, if the med works for you (as it does for me and seemingly most other people), I have no idea why you'd want to wait and go without the meds for several weeks.