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NCT04096560 · ClinicalTrials.gov registry record · Phase 2
A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy
A Phase 2 study, sponsored by Takeda.
- Terminated
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
NCT04096560: Clinical Trial Phase 2 study, sponsored by Takeda.
NCT04096560 is a Phase 2 study that was terminated before completion, run by Takeda. The registered enrollment target is 97 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04096560, a Phase 2 study, was terminated before completion, sponsored by Takeda.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
Study Summary
The main aims of the study are: * To check for side effects from TAK-994 and check what dose of TAK-994 participants can tolerate. * To check what dose range provides adequate relief of narcolepsy symptoms. * To check how much TAK-994 stays in the blood of participants, over time. The study will have 4 parts. Participants can only join 1 of the parts. A. Participants with type 1 narcolepsy will take either TAK-994 or placebo tablets for 28 days. A placebo looks just like TAK-994 but will not have any medicine in it. B. Participants with type 1 narcolepsy will take 1 of 3 doses of TAK-994 or placebo tablets for 56 days. C. Participants with type 1 narcolepsy in China only will take TAK-994 or placebo tablets for 56 days. D. Participants with type 2 narcolepsy will take either TAK-994 or placebo tablets for 28 days.
Primary Outcome
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that oc
Interventions
- DRUG Placebo
- DRUG TAK-994
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2020-05-27 |
| Est. Completion | 2021-11-05 |
| Phase | Phase 2 |
Why NCT04096560 stopped before completion
NCT04096560 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04096560 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04096560 about?
NCT04096560 is a clinical study titled "A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy". The main aims of the study are: * To check for side effects from TAK-994 and check what dose of TAK-994 participants can tolerate. * To check what dose range provides adequate relief of narcolepsy symptoms. * To check how much TAK-994 stays in the blood of participants, over time. The study will h...
What is the current status of trial NCT04096560?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2020-05-27. Estimated completion is 2021-11-05.
What interventions are being tested in trial NCT04096560?
The interventions under investigation include: Placebo (DRUG), TAK-994 (DRUG).
Who is sponsoring clinical trial NCT04096560?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04096560's enrollment target sits among peer trials
97 746th of 2000 higher than 1,254 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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