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Due to business reasons prior to first subject dosed.
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This is a study of TAK-951 in participants with cyclic vomiting syndrome (CVS).
The main aims of this study are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 (ABBA): Placebo + TAK-951 4 mg + TAK-951 4 mg + Placebo | Experimental | Participants will 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 will be maintained between each Period. |
|
| Sequence 2 (BAAB): TAK-951 4 mg + Placebo + Placebo + TAK-951 4 mg | Experimental | Participants will 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 will be maintained between each Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-951 | Drug | TAK-951 subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to end of study (up to 44 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
The participant has participated in another interventional study within 4 weeks or 5 half-lives of the investigational study drug, whichever is longer, before the screening visit. The 4-week window will be derived from the date of the last study procedure and/or AE related to the study procedure in the previous study to the screening visit of the current study.
The participant has potentially received TAK-951 in a previous clinical study, or has previously completed, discontinued, or withdrawn from this study.
The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (example, spouse, parent, child, sibling) or is unable to provide consent (example, incapacity or potential duress or undue influence on informed consent process).
The participant has a history of significant multiple and/or severe allergies (example, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance (including medication-induced emesis) to prescription or nonprescription drugs or food, or allergic reactions to allowed rescue medication(s).
The participant has any condition or abnormality (including laboratory abnormalities), current or past, that, in the opinion of the investigator or medical monitor, would compromise the safety of the participant or interfere with or complicate the assessment of signs or symptoms of CVS.
The participant uses medical or recreational cannabis more than 3 days/week or its usage triggers nausea and/or vomiting.
The participant has a history of hypotension, autonomic instability, orthostatic hypotension (excluding in the context of concurrent dehydration), postural orthostatic tachycardia syndrome or a history or presence of 2 or more incidents of syncope within the last 5 years before screening.
Has a history of long corrected QT interval QTc, history of significant cardia arrhythmia, or a history or presence of:
The participant has a history of other cardiovascular disease or cerebrovascular disease as assessed by the investigator including: essential hypertension requiring therapy or a history or presence of cerebrovascular disease such as cardiac valvulopathy, myocardial infarction, or stroke.
The participant has an average semirecumbent systolic blood pressure (SBP) < 95 or >140 or a diastolic blood pressure (DBP) <65 millimeter of mercury (mmHg) or >90 mm Hg at screening.
The participant has a screening average heart rate (HR) <55 or >100 bpm; athletic participants with a HR <55 bpm may be enrolled based upon the investigator's judgement provided that HR is >45 bpm and rhythm is sinus bradycardia.
The participant has orthostatic hypotension defined as a decrease in systolic blood pressure (BP) >=20 mmHg or a decrease in diastolic BP >=10 mmHg after approximately 3 minutes of standing when compared with BP from the semirecumbent position, at screening.
The participant has postural orthostatic tachycardia, defined as an increase of 30 bpm or HR >120 bpm after standing for approximately 3 minutes, at screening.
The participant is taking medications commonly associated with tachycardia, palpitations, hypotension, or QTc prolongation as potential adverse effects (example, beta blockers, nitrates, sildenafil).
The participant is taking medications prescribed for the prophylactic management of CVS with possible safety or tolerability interactions with TAK-951 as determined by the investigator(s). As above, chronic (>3 months) consistent dose of tricyclic antidepressants are allowed after consultation with the medical monitor if QTcF is <470. The use of prochlorperazine/or promethazine as a rescue medication is explicitly prohibited until >30 hours (5 half-lives of TAK-951) after investigational product administration.
The participant has a history of autonomic dysfunction.
The participant has active neoplastic disease or history of neoplastic disease within 5 years of screening visit (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix that has been definitively treated with standard of care approaches) and has received treatment in the last 5 years.
The participant has a history of requiring emergency room/urgent medical treatment and intravenous fluid therapy for management of dehydration associated with clinically relevant hypotension for >2 CVS episodes in the last 6 months.
The participant has a history of other conditions associated with episodic emesis including: type 1 diabetes mellitus, type 2 diabetes mellitus, gastroparesis, gastrointestinal dysmotility, inflammatory bowel disease, eosinophilic esophagitis, rumination, severe functional dyspepsia, severe gastrointestinal reflux disease, large (>3 centimeter [cm]) hiatal hernia, or unrepaired intestinal malrotation.
The participant has taken opiate medications for more than 3 days in the last month.
The participant has a progressive neurological disorder or a structural disorder of the brain from birth, trauma or past infection.
The participant has an uncontrolled psychiatric disorder, to include history of suicide attempt, active major depressive disorder or severe panic disorder, or at the discretion of the investigator(s), for any clinically significant psychiatric history that would likely interfere with full participation in the study.
The participant has started a nonpharmacologic prophylactic approach (example, acupuncture, biofeedback, chiropractic methods) within 1 month before initiation of the treatment period.
The participant has a history of substance abuse.
The participant has a positive pregnancy test or plans to become pregnant during the study period.
The participant is a pregnant or lactating/nursing female.
The participant has a history of intolerance, hypersensitivity, or idiosyncratic reaction to TAK-951 (or any other glucose-dependent insulinotropic polypeptide [GIP] receptor agonist investigational products) or to any other ingredients of the investigational product.
The participant has a clinically unstable disease or condition.
The participant has any disease or condition that could compromise the function of those body systems as assessed by the investigator that could result in altered absorption, excess accumulation, or impaired metabolism or excretion of the test medications (example, mild, moderate or severe renal impairment [that is, creatinine clearance <90 milliliter per minute [mL/min] CrCL]) and/or altered hepatic function as assessed by the investigator (example, alanine aminotransferase [ALT] >2*the upper limit of normal [ULN], total bilirubin [TB]>1.5*ULN, alkaline phosphatase >1.5*ULN).
The participant has known or suspected active coronavirus disease 2019 infection as assessed by the investigator.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Phase Research & Development | Knoxville | Tennessee | 37909-1161 | United States |
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| Label | URL |
|---|---|
| To obtain more information on the study, click this link. | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Up to end of study (up to 44 weeks) |
|
Adverse Events (AEs) were not collected in this study.
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 death, serious adverse events (SAEs) and non-serious AE data were evaluated and collected to be reported in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants were to receive TAK-951 placebo-matching injection (Treatment A), subcutaneously, single dose, on Day 1 in CVS Episodes 1, 2, 3, or 4 (Periods 1, 2, 3 or 4). A washout period of at least 14 days was planned to be maintained between each Period. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 19, 2021 | Jan 10, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 9, 2021 | Jan 10, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| TAK-951 Placebo | Drug | TAK-951 placebo-matching subcutaneous injection. |
|
| 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). | 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. | 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. | 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. | 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. | 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. | 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. | Up to end of study (up to 44 weeks) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
| Sex: Female, Male | 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. | participants |
|
| Ethnicity (NIH/OMB) | 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. | participants |
|
| Race (NIH/OMB) | 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. | participants |
|
| Region of Enrollment | 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. | participants |
|
Participants were to receive TAK-951 placebo-matching injection (Treatment A), subcutaneously, single dose, on Day 1 in CVS Episodes 1, 2, 3, or 4 (Periods 1, 2, 3 or 4). A washout period of at least 14 days was planned to be maintained between each Period. |
| OG001 | TAK-951 4 mg | Participants were to receive TAK-951 4 mg (Treatment B), injection, subcutaneously, single dose, on Day 1 in CVS Episodes 1, 2, 3, or 4 (Periods 1, 2, 3 or 4). A washout period of at least 14 days was planned to be maintained between each Period. |
|
| Secondary | 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. | 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. | Posted | Within 2, 4, and 8 hours post-dose |
|
|
| Secondary | 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). | 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. | Posted | Within 2, 4, and 8 hours post-dose |
|
|
| Secondary | 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. | 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. | Posted | Within 2, 4, and 8 hours post-dose |
|
|
| Secondary | 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. | 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. | Posted | At 0, 1 and 2 hours post-dose |
|
|
| Secondary | 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. | 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. | Posted | At 4 and 8 hours post-dose |
|
|
| Secondary | 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. | 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. | Posted | At 1 and 2 hours post-dose |
|
|
| Secondary | 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. | 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. | Posted | At 4 and 8 hours post-dose |
|
|
| Secondary | 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. | 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. | Posted | Up to end of study (up to 44 weeks) |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | TAK-951 4 mg | Participants were to receive TAK-951 4 mg (Treatment B), injection, subcutaneously, single dose, on Day 1 in CVS Episodes 1, 2, 3, or 4 (Periods 1, 2, 3 or 4). A washout period of at least 14 days was planned to be maintained between each Period. | 0 | 0 | 0 | 0 | 0 | 0 |
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