Efficacy and Safety of Elpipodect (MK-8189) in Participan... | NCT04624243 | Trialant
NCT04624243
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Apr 29, 2026Actual
Enrollment
499Actual
Phase
Phase 2
Conditions
Schizophrenia
Interventions
Elpipodect
Risperidone
Placebo to MK-8189
Placebo to risperidone
Countries
United States
Bulgaria
Croatia
Japan
Latvia
Poland
Romania
Russia
Serbia
South Korea
Taiwan
Ukraine
Protocol Section
Identification Module
NCT ID
NCT04624243
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
8189-008
Secondary IDs
ID
Type
Description
Link
MK-8189-008
Other Identifier
Merck Protocol Number
jRCT2071200096
Registry Identifier
jRCT
2020-000094-24
EudraCT Number
Brief Title
Efficacy and Safety of Elpipodect (MK-8189) in Participants With an Acute Episode of Schizophrenia (MK-8189-008)
Official Title
A Phase 2B Randomized, Double-Blind, Placebo- and Active-Controlled Trial of the Efficacy and Safety of MK-8189 in Participants Experiencing an Acute Episode of Schizophrenia
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Apr 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 15, 2020Actual
Primary Completion Date
Jun 21, 2024Actual
Completion Date
Jun 21, 2024Actual
First Submitted Date
Nov 5, 2020
First Submission Date that Met QC Criteria
Nov 5, 2020
First Posted Date
Nov 10, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Jun 20, 2025
Results First Submitted that Met QC Criteria
Aug 20, 2025
Results First Posted Date
Aug 22, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 8, 2026
Last Update Posted Date
Apr 29, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study was to evaluate the efficacy and safety of elpipodect at a range of doses (8 mg, 16 mg, and 24 mg once daily [QD]) in adult participants who have an acute episode of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria. The primary hypotheses were the following: (1) that elpipodect 24 mg is superior to placebo in reducing the Week 6 mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score, and (2) that elpipodect 16 mg is superior to placebo in reducing the Week 6 mean change from baseline in PANSS total score.
With Amendment 4, enrollment was changed to approximately 500 participants with removal of the elpipodect 8 mg treatment arm. Participants enrolled before Amendment 4 who were assigned to elpipodect 8 mg QD remained on that dose regimen per protocol.
Detailed Description
Not provided
Conditions Module
Conditions
Schizophrenia
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
499Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Elpipodect 8 mg
Experimental
Participants received elpipodect 8 mg QD from Weeks 1 to 12, with 2 weeks of follow-up
Drug: Elpipodect
Drug: Placebo to risperidone
Elpipodect 16 mg
Experimental
Participants received elpipodect 16 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
Drug: Elpipodect
Drug: Placebo to risperidone
Elpipodect 24 mg
Experimental
Participants received elpipodect 24 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
Drug: Elpipodect
Drug: Placebo to risperidone
Risperidone 6 mg
Active Comparator
Participants will be treated for a total of 12 weeks. Participants will receive risperidone 6 mg QD in the acute treatment period from Week 1-6 followed by risperidone 6 mg QD in the extension treatment period from Week 7-12.
Drug: Risperidone
Drug: Placebo to MK-8189
Placebo and Elpipodect 24 mg
Experimental
Participants received placebo QD from Weeks 1 to 6 and elpipodect 24 mg from Weeks 7 to 12, with 2 weeks of follow-up.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Elpipodect
Drug
MK-8189 administered QD at a dose of 8 mg, 16 mg, or 24 mg via oral tablet.
Elpipodect 16 mg
Elpipodect 24 mg
Elpipodect 8 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
The PANSS assesses the severity of schizophrenia symptoms through a 30-item clinician-rated inventory organized into a positive subscale (7 items), a negative subscale (7 items) and a general psychopathology subscale (16 items). For each item, symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme). The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranges from 30 (lowest total score) to 210 (highest total score). Higher and lower change scores reflect symptom worsening and improvement, respectively. Risperidone and placebo were active and inactive controls, respectively.
Baseline and Week 6
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, events were assessed for the first 6 weeks of treatment.
Up to Week 6
Number of Participants Who Discontinued From Study Intervention Due to AE
An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, events were assessed for the first 6 weeks of treatment.
Up to Week 6
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in PANSS Positive Subscale (PSS) Score at Week 6
The PANSS Positive Subscale (PSS) assesses the severity of schizophrenia symptoms. The PANSS PSS score was calculated as the sum of the rating assigned to each of the 7 PSS items and ranges from 7 (lowest total score) to 49 (highest total score). Higher and lower change scores reflect symptom worsening and improvement, respectively. Risperidone and placebo were active and inactive controls, respectively.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
The main inclusion criteria include, but are not limited to the following:
Meet the diagnostic criteria for schizophrenia according to the DSM-5
Have an illness duration for schizophrenia of at least 1 year
Be confirmed to be experiencing an acute episode of schizophrenia as evidenced by ALL of the following: (a) onset of the current acute episode is ≤6 weeks before screening (b) current symptoms represent a marked and substantial worsening compared with the participant's usual symptomatic state prior to the current acute episode, and are associated with diminished functional ability (c) in need of increased psychiatric attention to treat worsening acute episode symptoms
Have a CGI-S score of ≥4 (moderately ill) at screening and baseline
Have an identified responsible person referred to as the "external contact person" who has agreed to provide information about the participant's location if needed during outpatient portion of the study. The site personnel must consider this identified responsible person a reliable contact person, and the contact person must have regular contact with the participant (defined at screening as direct contact no fewer than 3 times per week), and with the expectation that this frequency of contact would continue (either in person or via other contact method), throughout duration of the study, including the follow-up period)
Exclusion Criteria:
The main exclusion criteria include, but are not limited to the following:
Has a primary current diagnosis other than schizophrenia or a comorbid diagnosis that is primarily responsible for the current symptoms and functional impairment
Meets criteria for moderate to severe substance use disorder within past 6 months prior to screening (excluding those related to caffeine or nicotine)
Has a known history of the following: (a) borderline personality disorder, anti-social personality disorder, or bipolar disorder (b) traumatic brain injury causing ongoing cognitive difficulties, Alzheimer's Disease, or another form of dementia, or any chronic organic disease of the central nervous system (c) intellectual disability of a severity that would impact ability to participate in the study
Has a current diagnosis of a psychotic disorder other than schizophrenia or a behavioral disturbance thought to be due to substance abuse
Is or was under involuntary commitment for the acute episode, because the participant is considered a danger to themselves or others
Has a history of treatment resistance exhibited by any of the following: (a) no or minimal response to at least 2 periods of treatment lasting 6 weeks or longer, with antipsychotic agents at the maximally tolerated dose. Participants who have responded to antipsychotics only when paired with clozapine are considered treatment-resistant (b) history of electroconvulsive therapy (ECT) treatment for treatment-resistant schizophrenia within the past 6 months (c) past or current use of clozapine as single or adjunctive therapy for schizophrenia within the past 3 months
Is currently participating in or has participated in another clinical study and received an experimental or investigational drug agent within 3 months prior to screening visit of this current study and has participated in no more than 2 studies in the past 2 years
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
55 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director
Merck Sharp & Dohme LLC
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pillar Clinical Research ( Site 1047)
Bentonville
Arkansas
72712-3873
United States
Woodland International Research Group, LLC ( Site 1002)
Randomization into the MK-8189 8 mg arm ceased as of Amendment 4.
Recruitment Details
Participants were enrolled and randomized at 75 study sites in 11 countries.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MK-8189 8 mg
Participants received MK-8189 8 mg once daily (QD) from Weeks 1 to 12, with 2 weeks of follow-up.
FG001
MK-8189 16 mg
Participants received MK-8189 16 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Mar 16, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Drug: Elpipodect
Drug: Placebo to MK-8189
Drug: Placebo to risperidone
Placebo and Elpipodect 24 mg
MK-8189
Risperidone
Drug
Risperidone administered QD at a dose of 6 mg via oral capsule.
Risperidone 6 mg
Placebo to MK-8189
Drug
MK-8189-matching placebo administered QD via oral tablet.
Placebo and Elpipodect 24 mg
Risperidone 6 mg
Placebo to risperidone
Drug
Risperidone-matching placebo administered QD via oral capsule.
Elpipodect 16 mg
Elpipodect 24 mg
Elpipodect 8 mg
Placebo and Elpipodect 24 mg
Baseline and Week 6
Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 6
The CGI-S is a single item 7-point clinician rated scale for assessing the global severity of the participant's illness. CGI-S scores range from 1 (participant normal, not ill) to 7 (participant extremely ill); higher and lower change from baseline scores indicate symptom worsening and improvement, respectively. Risperidone and placebo were active and inactive controls, respectively.
Baseline and Week 6
Change From Baseline in Body Weight at Week 12
The change from baseline in body weigh was determined at Week 12. Negative and positive values represent body weight loss and gain from baseline, respectively. Weight was measured using a standardized scale. Risperidone and placebo were active and inactive controls, respectively.
Baseline and Week 12
Change From Baseline in Body Weight at Week 6
The change from baseline in body weigh was determined at Week 6. Negative and positive values represent body weight loss and gain from baseline, respectively. Weight was measured using a standardized scale. Risperidone and placebo were active and inactive controls, respectively.
Baseline and Week 6
Change From Baseline in Body Weight at Week 12: Model-based Analysis
The change from baseline in body weigh was determined at Week 12. Negative and positive values represent body weight loss and gain from baseline, respectively. Weight was measured using a standardized scale. Risperidone and placebo were active and inactive controls, respectively.
Baseline and Week 12
Change From Baseline in Body Weight at Week 6: Model-based Analysis
The change from baseline in body weigh was determined at Week 6. Negative and positive values represent body weight loss and gain from baseline, respectively. Weight was measured using a standardized scale. Risperidone and placebo were active and inactive controls, respectively.
Baseline and Week 6
Little Rock
Arkansas
72211
United States
Woodland Research Northwest, LLC ( Site 1036)
Rogers
Arkansas
72758
United States
CITRIALS ( Site 1010)
Bellflower
California
90706
United States
ProScience Research Group ( Site 1046)
Culver City
California
90230
United States
Collaborative Neuroscience Research, LLC ( Site 1041)
Garden Grove
California
92845
United States
Behavioral Research Specialists, LLC ( Site 1032)
Glendale
California
91206
United States
CITRIALS ( Site 1016)
Riverside
California
92506
United States
Artemis Institute for Clinical Research ( Site 1019)
San Diego
California
92103
United States
California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC) ( Site 103
San Diego
California
92123
United States
Schuster Medical Research Institute ( Site 1023)
Sherman Oaks
California
91403
United States
Behavioral Clinical Research ( Site 1058)
Hollywood
Florida
33021
United States
Research Centers of America ( Hollywood )-Central Nervous System (CNS) ( Site 1065)
Hollywood
Florida
33024
United States
Premier Clinical Research Institute ( Site 1049)
Miami
Florida
33122
United States
Behavioral Clinical Research , Inc ( Site 1013)
Miami Lakes
Florida
33016
United States
Fort Lauderdale Behavioral Health Center ( Site 1028)
Oakland Park
Florida
33334
United States
Health Synergy Clinical Research ( Site 1051)
Stuart
Florida
34997
United States
Atlanta Center For Medical Research ( Site 1022)
Atlanta
Georgia
30331
United States
CenExel iResearch, LLC ( Site 1039)
Decatur
Georgia
30030
United States
Ascension Saint Elizabeth ( Site 1000)
Chicago
Illinois
60622
United States
Uptown Research Institute ( Site 1052)
Chicago
Illinois
60640
United States
Pillar Clinical Research, LLC ( Site 1038)
Chicago
Illinois
60641
United States
Benchmark Research ( Site 1054)
Shreveport
Louisiana
71101
United States
CBH Health ( Site 1044)
Gaithersburg
Maryland
20877
United States
Massachusetts General Hospital ( Site 1035)
Boston
Massachusetts
02114
United States
Arch Clinical Trials ( Site 1048)
St Louis
Missouri
63141
United States
Altea Research Institute ( Site 1012)
Las Vegas
Nevada
89102
United States
Hassman Research Institute Marlton Site ( Site 1040)
Marlton
New Jersey
08053
United States
Richmond Behavioral Associates ( Site 1064)
Staten Island
New York
10314
United States
New Hope Clinical Research ( Site 1050)
Charlotte
North Carolina
28211
United States
Midwest Clinical Research ( Site 1059)
Dayton
Ohio
45417
United States
Midwest Clinical Research Center ( Site 1033)
Dayton
Ohio
45417
United States
Neuro-Behavioral Clinical Research ( Site 1055)
North Canton
Ohio
44720
United States
Community Clinical Research ( Site 1057)
Austin
Texas
78754
United States
Pillar Clinical Research, LLC ( Site 1004)
Richardson
Texas
75080
United States
State Psychiatric Hospital "Sv. Ivan Rilski", Novi Iskar ( Site 3001)
Novi Iskar
Sofia
1282
Bulgaria
Mental Health Center Prof. Dr. Ivan Temkov - Burgas EOOD ( Site 3002)
Burgas
8001
Bulgaria
State Psychiatric Hospital - Kardzhali ( Site 3005)
Kardzhali
6600
Bulgaria
Mental Health Center - Ruse, EOOD ( Site 3003)
Rousse
7000
Bulgaria
Center for Mental Health Prof. Nikola Shipkovenski Ltd ( Site 3000)
Sofia
1000
Bulgaria
Mental Health Center - Veliko Tarnovo ( Site 3006)
Veliko Tarnovo
5000
Bulgaria
Klinika za psihijatriju Vrapce ( Site 4000)
Zagreb
City of Zagreb
10090
Croatia
Klinika za psihijatriju Vrapce ( Site 4001)
Zagreb
City of Zagreb
10090
Croatia
Klinicki bolnicki centar Rijeka ( Site 4005)
Rijeka
Primorje-Gorski Kotar County
51000
Croatia
Klinika za psihijatriju Sveti Ivan ( Site 4003)
Zagreb
Zagreb County
10090
Croatia
Seishinkai Okehazama Hospital Fujita Kokoro Care Center ( Site 2011)
Toyoake
Aichi-ken
470-1168
Japan
Kohnodai Hospital, National Center for Global Health and Medicine ( Site 2005)
Ichikawa
Chiba
272-8516
Japan
Wakato Hospital ( Site 2031)
Kitakyushu
Fukuoka
808-0139
Japan
Shiranui Hospital ( Site 2043)
Omuta
Fukuoka
8360004
Japan
Seimou Hospital ( Site 2004)
Tomioka
Gunma
3702455
Japan
Soushu Hospital ( Site 2008)
Atsugi
Kanagawa
243-0201
Japan
Tanzawa Hospital ( Site 2037)
Hadano
Kanagawa
259-1304
Japan
Kanagawa Psychiatric Center ( Site 2035)
Yokohama
Kanagawa
233-0006
Japan
Komoro Kogen Hospital ( Site 2046)
Komoro
Nagano
384-8540
Japan
National Hospital Organization Ryukyu Hospital ( Site 2019)
Kunigamigun
Okinawa
904-1201
Japan
Amekudai Hospital ( Site 2020)
Naha
Okinawa
900-0005
Japan
National Hospital Organization Hizen Psychiatric Medical Center ( Site 2017)
Kanzaki-gun
Saga-ken
8420192
Japan
Rainbow and Sea Hospital ( Site 2016)
Karatsu
Saga-ken
847-0031
Japan
Ongata Hospital ( Site 2007)
Hachiōji
Tokyo
192-0153
Japan
Nishigahara Hospital ( Site 2042)
Kita-ku
Tokyo
114-0024
Japan
National Center of Neurology and Psychiatry ( Site 2023)
Kodaira
Tokyo
187-8551
Japan
Chiba University Hospital ( Site 2024)
Chiba
260-8677
Japan
Inokuchi Noma Hospital ( Site 2030)
Fukuoka
815-0074
Japan
Kuramitsu Hospital ( Site 2014)
Fukuoka
819-0037
Japan
Yuge Hospital ( Site 2018)
Kumamoto
861-8002
Japan
Seijin Hospital ( Site 2026)
Tokyo
121-8515
Japan
Narimasu Kosei Hospital ( Site 2006)
Tokyo
175-0091
Japan
Daugavpils Psihoneirologiska Slimnica ( Site 8005)
Daugavpils
5417
Latvia
Piejuras Slimnica Psihiatriska Klinika ( Site 8001)
Liepāja
3401
Latvia
Centrum Medyczne HCP ( Site 0913)
Poznan
Greater Poland Voivodeship
61-485
Poland
Klinika Psychiatryczna Wydzialu Nauki o Zdrowiu WUM ( Site 0900)
Pruszków
Masovian Voivodeship
05-802
Poland
Samodzielny Wojewódzki Zespół Publicznych Zakładów Psychiatrycznej Opieki Zdrowotnej w Warszawie ( S
Warsaw
Masovian Voivodeship
00-665
Poland
Uniwersyteckie Centrum Kliniczne ( Site 0902)
Gdansk
Pomeranian Voivodeship
80-211
Poland
Specjal. Psychiatryczny ZOZ w Lodzi, Szpital im. Babinskiego ( Site 0905)
Lodz
Łódź Voivodeship
91-229
Poland
Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0815)
Bucharest
Bucharest
041914
Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0816)
Bucharest
Bucharest
041914
Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0817)
Bucharest
Bucharest
041914
Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital ( Site 0818)
Bucharest
Bucharest
041914
Romania
Institutul de Psihiatrie Socola ( Site 0810)
Iași
Iaşi
700282
Romania
Institutul de Psihiatrie Socola ( Site 0814)
Iași
Iaşi
700282
Romania
Arkhangelsk Regional Psychiatric Clinical Hospital ( Site 6020)
Arkhangelsk
Arkhangelskaya oblast
163530
Russia
SGHI Leningrad Region Psyconeurology Dispensary ( Site 6017)
Leningrad Region
Leningradskaya Oblast'
188820
Russia
Lipetsk Regional Psychoneurology Hospital ( Site 6021)
Lipetsk
Lipetsk Oblast
399083
Russia
Moscow Scientific Research Institute for Psychiatry ( Site 6013)
Moscow
Moscow
107076
Russia
Psychiatric Clinical Hospital 4 named after PB Gannushkin ( Site 6016)
Moscow
Moscow
107076
Russia
Psychiatric Clinical Hospital 4 named after PB Gannushkin-Psychiatric department 4 ( Site 6023)
Moscow
Moscow
107076
Russia
Central Moscow Regional Clinical Psychiatric Hospital ( Site 6018)
Moscow
Moscow
127083
Russia
Bekhterev Research Institute for Psychoneurology ( Site 6008)
Saint Petersburg
Sankt-Peterburg
192019
Russia
SPb City Psychiatric Hospital #3 na II Skvortsov-Stepanov ( Site 6000)
Saint Petersburg
Sankt-Peterburg
197341
Russia
SPb City Psychiatric Hospital #3 na II Skvortsov-Stepanov ( Site 6001)
Saint Petersburg
Sankt-Peterburg
197341
Russia
SPb City Psychiatric Hospital #3 na II Skvortsov-Stepanov ( Site 6002)
Saint Petersburg
Sankt-Peterburg
197341
Russia
Stavropol Region Psychiatric Hospital #2 ( Site 6005)
Stavropol
Stavropol Kray
357034
Russia
Federal State Scientific Institution Research Institute of Mental Health ( Site 6014)
Tomsk
Tomsk Oblast
634014
Russia
Yaroslavl Regional Clinical Psychiatry Hospital ( Site 6022)
Yaroslavl
Yaroslavl Oblast
150003
Russia
Clinical Center of Serbia ( Site 5101)
Belgrade
Beograd
11000
Serbia
Clinical Center of Serbia ( Site 5107)
Belgrade
Beograd
11000
Serbia
Institut za mentalno zdravlje ( Site 5105)
Belgrade
Beograd
11000
Serbia
University Clinical Hospital Center "Dr. Dragisa Misovic - Dedinje" ( Site 5104)
Belgrade
Beograd
11000
Serbia
Clinical Center Kragujevac ( Site 5100)
Kragujevac
Sumadijski Okrug
34000
Serbia
Clinical Center Kragujevac ( Site 5102)
Kragujevac
Sumadijski Okrug
34000
Serbia
Clinical Center Kragujevac ( Site 5106)
Kragujevac
Sumadijski Okrug
34000
Serbia
Special Hospital for Psychiatric Diseases Kovin ( Site 5108)
Kovin
Vojvodina
26220
Serbia
Special Hospital for Psychiatric Diseases Kovin ( Site 5109)
Kovin
Vojvodina
26220
Serbia
Inje University Busan Paik Hospital ( Site 0604)
Busan
Pusan-Kwangyokshi
47392
South Korea
Kyungpook National University Hospital ( Site 0601)
Daegu
Taegu-Kwangyokshi
41944
South Korea
Seoul National University Hospital ( Site 0600)
Seoul
03080
South Korea
China Medical University Hospital ( Site 9006)
Taichung
404
Taiwan
National Taiwan University Hospital ( Site 9001)
Taipei
100
Taiwan
Taipei City Hospital, Songde Branch ( Site 9004)
Taipei
110
Taiwan
Taipei Veterans General Hospital ( Site 9000)
Taipei
11217
Taiwan
Chang Gung Memorial Hospital - Linkou Branch ( Site 9002)
Taoyuan
333
Taiwan
CNE Cherkasy reg. psychiatric hospital of Cherkasy regional council ( Site 7009)
Smila
Cherkasy Oblast
20708
Ukraine
Dnepropetrovsk Regional Clinical Hospital Mechnikov-Regional Centre of Psychosomatic Disorders base
Dnipro
Dnipropetrovsk Oblast
49005
Ukraine
CNE "Precarpathian Regional Clinical Center of Mental Health of Ivano-Frankivsk Regional Council"" (
Ivano-Frankivsk
Ivano-Frankivsk Oblast
76014
Ukraine
CNE of Kharkiv Reg. Council Reg. Clinical Psychiatric Hospital Nub 3 ( Site 7012)
Kharkiv
Kharkiv Oblast
61068
Ukraine
Institute of Neurology,Psychiatry and Narcology AMS Ukraine ( Site 7011)
Kharkiv
Kharkiv Oblast
61068
Ukraine
CNE. Kherson Regional Psychiatric Hospital ( Site 7004)
Kherson
Kherson Oblast
73488
Ukraine
Kyiv City Psychoneurological Hospital 2 ( Site 7008)
Kyiv
Kyivska Oblast
02192
Ukraine
CNE Clinical Hospital PSYCHIATRY of executive body of Kyiv City Council -Kyiv City State Admin ( Sit
Kyiv
Kyivska Oblast
04080
Ukraine
MNE of KRC-Regional psychiatric and narcological medical association ( Site 7005)
Kyiv
Kyivska Oblast
08631
Ukraine
CNE "Vinnytsia Regional Clinical Psycho-neurological hospita-Mixed (men and women) department #2 ( S
Vinnytsia
Vinnytsia Oblast
21037
Ukraine
FG002
MK-8189 24 mg
Participants received MK-8189 24 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
FG003
Risperidone 6 mg
Participants received risperidone 6 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
FG004
Placebo and MK-8189 24 mg
Participants received placebo QD from Weeks 1 to 6 and MK-8189 24 mg from Weeks 7 to 12, with 2 weeks of follow-up.
FG00041 subjects
FG001132 subjects
FG002132 subjects
FG00365 subjects
FG004129 subjects
COMPLETED
FG00014 subjects
FG00164 subjects
FG00261 subjects
FG00337 subjects
FG00470 subjects
NOT COMPLETED
FG00027 subjects
FG00168 subjects
FG00271 subjects
FG00328 subjects
FG00459 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Lost to Follow-up
FG0002 subjects
FG0013 subjects
FG0027 subjects
FG0031 subjects
FG004
Physician Decision
FG0003 subjects
FG0018 subjects
FG00215 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG00019 subjects
FG00144 subjects
FG00240 subjects
FG00321 subjects
FG004
Miscellaneous
FG0003 subjects
FG00112 subjects
FG0029 subjects
FG0034 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MK-8189 8 mg
Participants received MK-8189 8 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
BG001
MK-8189 16 mg
Participants received MK-8189 16 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
BG002
MK-8189 24 mg
Participants received MK-8189 24 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
BG003
Risperidone 6 mg
Participants received risperidone 6 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
BG004
Placebo and MK-8189 24 mg
Participants received placebo QD from Weeks 1 to 6 and MK-8189 24 mg from Weeks 7 to 12, with 2 weeks of follow-up.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00041
BG001132
BG002132
BG00365
BG004129
BG005499
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00035.7± 8.9
BG00139.4± 9.0
BG00236.9± 9.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00012
BG00146
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG00114
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
The PANSS assesses the severity of schizophrenia symptoms through a 30-item clinician-rated inventory organized into a positive subscale (7 items), a negative subscale (7 items) and a general psychopathology subscale (16 items). For each item, symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme). The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranges from 30 (lowest total score) to 210 (highest total score). Higher and lower change scores reflect symptom worsening and improvement, respectively. Risperidone and placebo were active and inactive controls, respectively.
All participants who receive ≥1 dose of MK-8189 (16 mg or 24 mg), risperidone, or placebo, and have both a baseline measurement and ≥1 valid post-baseline assessment, are included. Per protocol, the effect of the 8 mg dose was not assessed.
Posted
Least Squares Mean
95% Confidence Interval
Score on a scale
Baseline and Week 6
ID
Title
Description
OG000
MK-8189 8 mg
Participants received MK-8189 8 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG001
MK-8189 16 mg
Participants received MK-8189 16 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG002
MK-8189 24 mg
Participants received MK-8189 24 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG003
Risperidone 6 mg
Participants received risperidone 6 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG004
Placebo and MK-8189 24 mg
Participants received placebo QD from Weeks 1 to 6 and MK-8189 24 mg from Weeks 7 to 12, with 2 weeks of follow-up.
Units
Counts
Participants
OG0000
OG00185
OG00268
OG003
Title
Denominators
Categories
Title
Measurements
OG001-20.7(-24.1 to -17.3)
OG002-18.5(-22.1 to -15.0)
OG003-24.0(-28.8 to -19.2)
OG004
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG004
ANCOVA
0.241
LS Mean Difference
-2.8
2-Sided
97.5
-8.3
2.6
Superiority
It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 PANSS change from baseline
OG002
OG004
ANCOVA
Primary
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, events were assessed for the first 6 weeks of treatment.
All participants who received ≥1 dose of study intervention are included.
Posted
Count of Participants
Participants
Up to Week 6
ID
Title
Description
OG000
MK-8189 8 mg
Participants received MK-8189 8 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG001
MK-8189 16 mg
Participants received MK-8189 16 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG002
MK-8189 24 mg
Participants received MK-8189 24 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG003
Risperidone 6 mg
Participants received risperidone 6 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
Secondary
Change From Baseline in PANSS Positive Subscale (PSS) Score at Week 6
The PANSS Positive Subscale (PSS) assesses the severity of schizophrenia symptoms. The PANSS PSS score was calculated as the sum of the rating assigned to each of the 7 PSS items and ranges from 7 (lowest total score) to 49 (highest total score). Higher and lower change scores reflect symptom worsening and improvement, respectively. Risperidone and placebo were active and inactive controls, respectively.
All participants who received ≥1 dose of MK-8189 (16 mg or 24 mg), risperidone, or placebo, and have both a baseline measurement and ≥1 valid post-baseline assessment, are included. Per protocol, the effect of the 8 mg dose was not assessed.
Posted
Least Squares Mean
95% Confidence Interval
Score on a scale
Baseline and Week 6
ID
Title
Description
OG000
MK-8189 8 mg
Participants received MK-8189 8 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG001
MK-8189 16 mg
Participants received MK-8189 16 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG002
MK-8189 24 mg
Participants received MK-8189 24 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
Secondary
Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 6
The CGI-S is a single item 7-point clinician rated scale for assessing the global severity of the participant's illness. CGI-S scores range from 1 (participant normal, not ill) to 7 (participant extremely ill); higher and lower change from baseline scores indicate symptom worsening and improvement, respectively. Risperidone and placebo were active and inactive controls, respectively.
All participants who received ≥1 dose of MK-8189 (16 mg or 24 mg), risperidone, or placebo, and have both a baseline measurement and ≥1 valid post-baseline assessment, are included. Per protocol, the effect of the 8 mg dose was not assessed.
Posted
Least Squares Mean
95% Confidence Interval
Score on a scale
Baseline and Week 6
ID
Title
Description
OG000
MK-8189 8 mg
Participants received MK-8189 8 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG001
MK-8189 16 mg
Participants received MK-8189 16 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG002
MK-8189 24 mg
Participants received MK-8189 24 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
Secondary
Change From Baseline in Body Weight at Week 12
The change from baseline in body weigh was determined at Week 12. Negative and positive values represent body weight loss and gain from baseline, respectively. Weight was measured using a standardized scale. Risperidone and placebo were active and inactive controls, respectively.
All participants who received ≥1 dose of MK-8189, risperidone, or placebo, and have both a baseline measurement and ≥1 valid post-baseline assessment, are included.
Posted
Mean
Standard Deviation
Kilograms
Baseline and Week 12
ID
Title
Description
OG000
MK-8189 8 mg
Participants received MK-8189 8 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG001
MK-8189 16 mg
Participants received MK-8189 16 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG002
MK-8189 24 mg
Participants received MK-8189 24 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG003
Risperidone 6 mg
Participants received risperidone 6 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
Primary
Number of Participants Who Discontinued From Study Intervention Due to AE
An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, events were assessed for the first 6 weeks of treatment.
All participants who received ≥1 dose of study intervention are included.
Posted
Count of Participants
Participants
Up to Week 6
ID
Title
Description
OG000
MK-8189 8 mg
Participants received MK-8189 8 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG001
MK-8189 16 mg
Participants received MK-8189 16 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG002
MK-8189 24 mg
Participants received MK-8189 24 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG003
Risperidone 6 mg
Participants received risperidone 6 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
Secondary
Change From Baseline in Body Weight at Week 6
The change from baseline in body weigh was determined at Week 6. Negative and positive values represent body weight loss and gain from baseline, respectively. Weight was measured using a standardized scale. Risperidone and placebo were active and inactive controls, respectively.
All participants who received ≥1 dose of MK-8189, risperidone, or placebo, and have both a baseline measurement and ≥1 valid post-baseline assessment, are included.
Posted
Mean
Standard Deviation
Kilograms
Baseline and Week 6
ID
Title
Description
OG000
MK-8189 8 mg
Participants received MK-8189 8 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG001
MK-8189 16 mg
Participants received MK-8189 16 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG002
MK-8189 24 mg
Participants received MK-8189 24 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG003
Risperidone 6 mg
Participants received risperidone 6 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
Secondary
Change From Baseline in Body Weight at Week 12: Model-based Analysis
The change from baseline in body weigh was determined at Week 12. Negative and positive values represent body weight loss and gain from baseline, respectively. Weight was measured using a standardized scale. Risperidone and placebo were active and inactive controls, respectively.
All participants who received ≥1 dose of MK-8189 (16 or 24 mg), risperidone, or placebo, and have both a baseline measurement and ≥1 valid post-baseline assessment, are included. Per protocol, the 8 mg arm was excluded from analysis.
Posted
Least Squares Mean
95% Confidence Interval
Kilograms
Baseline and Week 12
ID
Title
Description
OG000
MK-8189 8 mg
Participants received MK-8189 8 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG001
MK-8189 16 mg
Participants received MK-8189 16 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG002
MK-8189 24 mg
Participants received MK-8189 24 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG003
Risperidone 6 mg
Secondary
Change From Baseline in Body Weight at Week 6: Model-based Analysis
The change from baseline in body weigh was determined at Week 6. Negative and positive values represent body weight loss and gain from baseline, respectively. Weight was measured using a standardized scale. Risperidone and placebo were active and inactive controls, respectively.
All participants who received ≥1 dose of MK-8189 (16 or 24 mg), risperidone, or placebo, and have both a baseline measurement and ≥1 valid post-baseline assessment, are included. Per protocol, the 8 mg arm was excluded from analysis.
Posted
Least Squares Mean
95% Confidence Interval
Kilograms
Baseline and Week 6
ID
Title
Description
OG000
MK-8189 8 mg
Participants received MK-8189 8 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG001
MK-8189 16 mg
Participants received MK-8189 16 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG002
MK-8189 24 mg
Participants received MK-8189 24 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
OG003
Risperidone 6 mg
Time Frame
Up to ~14 weeks
Description
All treated participants are included. To accommodate the different treatments in the "Placebo and MK-8189 24 mg", data from Weeks 1 to 6 and Weeks 7 to 12 are presented separately.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
MK-8189 8 mg Weeks 1 to 6
Participants received MK-8189 8 mg QD from Weeks 1 to 6.
0
41
1
41
18
41
EG001
MK-8189 16 mg Weeks 1 to 6
Participants (who received MK-8189 16 mg Weeks 1 to 6) received MK-8189 16 mg QD from Weeks 1 to 6.
0
132
8
132
58
132
EG002
MK-8189 24 mg Weeks 1 to 6
Participants received MK-8189 24 mg QD from Weeks 1 to 6.
0
132
6
132
72
132
EG003
Risperidone 6 mg Weeks 1 to 6
Participants received risperidone 6 mg QD from Weeks 1 to 6.
0
65
2
65
19
65
EG004
Placebo Weeks 1 to 6
Participants received placebo QD from Weeks 1 to 6.
0
129
0
129
45
129
EG005
MK-8189 8 mg Weeks 7 to 12
Participants (who received MK-8189 8 mg Weeks 1 to 6) received MK-8189 8 mg QD from Weeks 7 to 12.
0
17
3
17
4
17
EG006
MK-8189 16 mg Weeks 7 to 12
Participants (who received MK-8189 16 mg Weeks 1 to 6) received MK-8189 16 mg QD from Weeks 7 to 12.
1
75
4
75
18
75
EG007
MK-8189 24 mg Weeks 7 to 12
Participants (who received MK-8189 24 mg) received MK-8189 24 mg QD from Weeks 7 to 12.
0
60
3
60
10
60
EG008
Risperidone 6 mg Weeks 7 to 12
Participants (who received risperidone 6 mg Weeks 1 to 6) received risperidone 8 mg QD from Weeks 7 to 12.
0
39
0
39
9
39
EG009
MK-8189 24 mg Weeks 7 to 12 (Placebo Weeks 1 to 6)
Participants (who received placebo Weeks 1 to 6) received MK-8189 24 mg Weeks 7 to 12.
0
85
2
85
25
85
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cholecystitis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected132 at risk
EG0020 affected132 at risk
EG0030 affected65 at risk
EG0040 affected129 at risk
EG0050 affected17 at risk
EG0060 affected75 at risk
EG0070 affected60 at risk
EG0080 affected39 at risk
EG0090 affected85 at risk
Abscess limb
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected132 at risk
EG0020 affected132 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected132 at risk
EG0020 affected132 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected132 at risk
EG0020 affected132 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected132 at risk
EG0020 affected132 at risk
EG003
Muscle rigidity
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected132 at risk
EG0020 affected132 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected132 at risk
EG0020 affected132 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected132 at risk
EG0020 affected132 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected132 at risk
EG0021 affected132 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected132 at risk
EG0020 affected132 at risk
EG003
Schizophrenia
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected41 at risk
EG0012 affected132 at risk
EG0025 affected132 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected132 at risk
EG0020 affected132 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected41 at risk
EG0010 affected132 at risk
EG0020 affected132 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected132 at risk
EG0020 affected132 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected41 at risk
EG0011 affected132 at risk
EG0020 affected132 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected41 at risk
EG0017 events7 affected132 at risk
EG0024 events3 affected132 at risk
EG0031 events1 affected65 at risk
EG0046 events5 affected129 at risk
EG0051 events1 affected17 at risk
EG0064 events2 affected75 at risk
EG0070 events0 affected60 at risk
EG0080 events0 affected39 at risk
EG0090 events0 affected85 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected41 at risk
EG0016 events6 affected132 at risk
EG0023 events3 affected132 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected41 at risk
EG00125 events21 affected132 at risk
EG00230 events25 affected132 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected41 at risk
EG0011 events1 affected132 at risk
EG0020 events0 affected132 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0004 events4 affected41 at risk
EG00121 events16 affected132 at risk
EG00234 events18 affected132 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected41 at risk
EG0013 events3 affected132 at risk
EG0023 events3 affected132 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected132 at risk
EG0020 events0 affected132 at risk
EG003
Weight increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected132 at risk
EG0020 events0 affected132 at risk
EG003
Akathisia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected41 at risk
EG0019 events8 affected132 at risk
EG00212 events12 affected132 at risk
EG003
Dystonia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected41 at risk
EG0014 events4 affected132 at risk
EG00210 events9 affected132 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0004 events4 affected41 at risk
EG00112 events12 affected132 at risk
EG00213 events11 affected132 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0005 events4 affected41 at risk
EG0018 events7 affected132 at risk
EG0023 events3 affected132 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected41 at risk
EG0018 events8 affected132 at risk
EG00213 events13 affected132 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0004 events4 affected41 at risk
EG00111 events7 affected132 at risk
EG00213 events10 affected132 at risk
EG003
Schizophrenia
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected41 at risk
EG0016 events6 affected132 at risk
EG00211 events11 affected132 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected132 at risk
EG0020 events0 affected132 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected132 at risk
EG0020 events0 affected132 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected132 at risk
EG0020 events0 affected132 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected132 at risk
EG0020 events0 affected132 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development