TerminatedPhase 1

A Study of TAK-951 in Participants With Cyclic Vomiting Syndrome (CVS)

Stopped: Due to business reasons prior to first subject dosed.

United States1 participantsStarted 2022-03-02

Plain-language summary

This is a study of TAK-951 in participants with cyclic vomiting syndrome (CVS). The main aims of this study are as follows: * To check for side effects from treatment with TAK-951. * To learn how much TAK-951 participants can receive without getting side effects from it. * To check how much TAK-951 stays in the blood over time to work out the best dose. * The dose of TAK-951 will be checked to see how much stays in their blood over time. * To see if it is possible to give treatment at home. Participants will be given TAK-951 injected just under the skin (subcutaneous or SC).

Who can participate

Age range18 Years – 50 Years

SexALL

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Inclusion criteria

✓. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements and is eligible for the study.
✓. The participant or, when applicable, the participants' legally acceptable representative signs and dates a written or electronic, informed consent form and any required privacy authorization before the initiation of any study procedures.
✓. The participant is male or female and aged 18 to 50 years, inclusive.
✓. The participant has at least a 1-year history of CVS diagnosis based on the Rome IV diagnostic criteria.
✓. The participant has had at least 4 CVS episodes over 6 months before screening during the last 12 months.
✓. If taking eligible medications prescribed for the prophylaxis of CVS, the participant must be receiving a stable dose for at least 3 months before screening.
✓. The participant is willing and able to exclusively use the protocol rescue medications if needed.
✓. The participant has a stereotypic prodrome with onset less than or equal to (\<=) 4 hours before CVS emetic events.

Exclusion criteria

What they're measuring

Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)

Timeframe: Up to end of study (up to 44 weeks)

Trial details

NCT IDNCT06768658

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-09

Results submitted2025-01-10

View on ClinicalTrials.gov More Nausea and Vomitting trials