Trial Outcomes & Findings for A Study of TAK-951 in Participants With Cyclic Vomiting Syndrome (CVS) (NCT NCT06768658)
NCT ID: NCT06768658
Last Updated: 2025-07-02
Results Overview
A TEAE was defined as an adverse event (AE) with an onset that occurs after receiving study drug. An AE was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (example, a clinically significant abnormal vital sign or laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it was considered related to the drug.
TERMINATED
PHASE1
1 participants
Up to end of study (up to 44 weeks)
2025-07-02
Participant Flow
The study was terminated by the sponsor due to business reasons, before any participant had been dosed in the study. One participant was screened but not dosed with study drug. No data were evaluated or collected for reporting in this study.
Participant milestones
| Measure |
Sequence 1 (ABBA): Placebo + TAK-951 4 mg + TAK-951 4 mg + Placebo
Participants were to receive TAK-951 placebo-matching injection (Treatment A), subcutaneously, single dose on Day 1 in CVS Episode 1 (Period 1), followed by TAK-951 4 milligram (mg) (Treatment B), injection, subcutaneously, single dose, on Day 1 in CVS Episode 2 (Period 2), further followed by TAK-951 4 mg (Treatment B), injection, subcutaneously, single dose on Day 1 in CVS Episode 3 (Period 3), and further followed by TAK-951 placebo-matching injection (Treatment A), subcutaneously, single dose on Day 1 in CVS Episode 4 (Period 4). A washout period of at least 14 days was planned to be maintained between each Period.
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Sequence 2 (BAAB): TAK-951 4 mg + Placebo + Placebo + TAK-951 4 mg
Participants were to receive TAK-951 4 mg (Treatment B), injection, subcutaneously, single dose on Day 1 in CVS Episode 1 (Period 1), followed by TAK-951 placebo-matching injection (Treatment A), subcutaneously, single dose on Day 1 in CVS Episode 2 (Period 2), further followed by TAK-951 placebo-matching injection (Treatment A), subcutaneously, single dose on Day 1 in CVS Episode 3 (Period 3), and further followed by TAK-951 4 mg (Treatment B), injection, subcutaneously, single dose on Day 1 in CVS Episode 4 (Period 4). A washout period of at least 14 days was planned to be maintained between each Period.
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Overall Study
STARTED
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0
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Overall Study
COMPLETED
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This study was terminated early and only enrolled one participant that received no treatment. Due to concerns that the participant would be at risk of being re-identified and received no treatment, no data were evaluated and collected to be reported in this study.
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Up to end of study (up to 44 weeks)Population: This study was terminated early and only enrolled one participant that received no treatment. Due to concerns that the participant would be at risk of being re-identified and received no treatment, no data were evaluated and collected to be reported in this study.
A TEAE was defined as an adverse event (AE) with an onset that occurs after receiving study drug. An AE was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (example, a clinically significant abnormal vital sign or laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it was considered related to the drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 2, 4, and 8 hours post-dosePopulation: This study was terminated early and only enrolled one participant that received no treatment. Due to concerns that the participant would be at risk of being re-identified and received no treatment, no data were evaluated and collected to be reported in this study.
Total response was defined as no emesis, no nausea (verbal rating scale \[VRS\] "none") and no need for rescue therapy before each time point. This was planned to be scored using a self-reported, 4-point VRS based on verbal responses of the participants to questions, where Score 0 - none; Score 1 - mild; Score 2 - moderate; and Score 3 - severe. Higher scores mean a worse outcome. Emesis was defined as vomiting (the forceful discharge of even the smallest amount of stomach contents) or retching (the same muscular movements as vomiting but without expulsion of stomach contents). Nausea was defined as the desire to vomit without the presence of expulsive muscular movements.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 2, 4, and 8 hours post-dosePopulation: This study was terminated early and only enrolled one participant that received no treatment. Due to concerns that the participant would be at risk of being re-identified and received no treatment, no data were evaluated and collected to be reported in this study.
Absence of emesis was defined as no emesis and no need for rescue medication before each time point. Emesis was defined as vomiting (the forceful discharge of even the smallest amount of stomach contents) or retching (the same muscular movements as vomiting but without expulsion of stomach contents).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 2, 4, and 8 hours post-dosePopulation: This study was terminated early and only enrolled one participant that received no treatment. Due to concerns that the participant would be at risk of being re-identified and received no treatment, no data were evaluated and collected to be reported in this study.
Significant nausea was defined as a VRS greater than or equal to (\>=) moderate. Absence of nausea was defined as VRS of "none" or "mild" and no need for rescue medication before the evaluation time point. This was planned to be scored using a self-reported, 4-point VRS based on verbal responses of the participants to questions, where Score 0 - none; Score 1 - mild; Score 2 - moderate; and Score 3 - severe. Higher scores mean a worse outcome. Nausea was defined as the desire to vomit without the presence of expulsive muscular movements.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 0, 1 and 2 hours post-dosePopulation: This study was terminated early and only enrolled one participant that received no treatment. Due to concerns that the participant would be at risk of being re-identified and received no treatment, no data were evaluated and collected to be reported in this study.
Nausea was defined as the desire to vomit without the presence of expulsive muscular movements. This was planned to be scored using a self-reported, 4-point VRS based on verbal responses of the participants to questions, where Score 0 - none; Score 1 - mild; Score 2 - moderate; and Score 3 - severe. Higher scores mean a worse outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 4 and 8 hours post-dosePopulation: This study was terminated early and only enrolled one participant that received no treatment. Due to concerns that the participant would be at risk of being re-identified and received no treatment, no data were evaluated and collected to be reported in this study.
Nausea was defined as the desire to vomit without the presence of expulsive muscular movements. This was planned to be scored using a self-reported, 4-point VRS based on verbal responses of the participants to questions, where Score 0 - none; Score 1 - mild; Score 2 - moderate; and Score 3 - severe. Higher scores mean a worse outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1 and 2 hours post-dosePopulation: This study was terminated early and only enrolled one participant that received no treatment. Due to concerns that the participant would be at risk of being re-identified and received no treatment, no data were evaluated and collected to be reported in this study.
Nausea was defined as the desire to vomit without the presence of expulsive muscular movements. This was planned to be scored using a self-reported, 4-point VRS based on verbal responses of the participants to questions, where Score 0 - none; Score 1 - mild; Score 2 - moderate; and Score 3 - severe. Higher scores mean a worse outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 4 and 8 hours post-dosePopulation: This study was terminated early and only enrolled one participant that received no treatment. Due to concerns that the participant would be at risk of being re-identified and received no treatment, no data were evaluated and collected to be reported in this study.
Nausea was defined as the desire to vomit without the presence of expulsive muscular movements. This was planned to be scored using a self-reported, 4-point VRS based on verbal responses of the participants to questions, where Score 0 - none; Score 1 - mild; Score 2 - moderate; and Score 3 - severe. Higher scores mean a worse outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to end of study (up to 44 weeks)Population: This study was terminated early and only enrolled one participant that received no treatment. Due to concerns that the participant would be at risk of being re-identified and received no treatment, no data were evaluated and collected to be reported in this study.
The ADA assessment was planned to be categorized as ADA negative, ADA positive and with low or high ADA titers. ADA negative was defined as participants who did not have a confirmed positive ADA status in any postbaseline assessment, and ADA positive as participants who had confirmed positive ADA status in any postbaseline assessment. High ADA titer was defined as participants who had at least 1 postbaseline ADA titer greater than (\>) a cutoff planned to be determined based on the actual titer data, and Low ADA titer as participants whose postbaseline ADA titer numbers were all less than or equal to (\<=) a cutoff planned to be determined based on the actual titer data.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
TAK-951 4 mg
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place