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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1
TAK-951 subcutaneous injection.
TAK-951 placebo-matching subcutaneous injection.
New Phase Research & Development
Knoxville, Tennessee, United States
Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)
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.
Time frame: Up to end of study (up to 44 weeks)
Number of Participants With Total Response
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.
Time frame: Within 2, 4, and 8 hours post-dose
Number of Participants With Absence of Emesis
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).
Time frame: Within 2, 4, and 8 hours post-dose
Number of Participants With Absence of Significant Nausea
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.
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Time frame: Within 2, 4, and 8 hours post-dose
Peak Nausea VRS Score in All Participants
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.
Time frame: At 0, 1 and 2 hours post-dose
Peak Nausea VRS Score in Participants Who Did Not Receive the Rescue Medication Before the Evaluation Timepoint
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.
Time frame: At 4 and 8 hours post-dose
Change From Baseline in Nausea VRS Score in All Participants
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.
Time frame: At 1 and 2 hours post-dose
Change From Baseline in Nausea VRS Score in Participants Who Did Not Receive the Rescue Medication Before the Evaluation Timepoint
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.
Time frame: At 4 and 8 hours post-dose
Number of Participants With Anti-drug Antibody (ADA)
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.
Time frame: Up to end of study (up to 44 weeks)