A Study of Rapastinel as Adjunctive Therapy in the Preven... | NCT02951988

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rapastinel 450 mg Weekly	Experimental	Rapastinel 450 milligrams (mg) intravenous (IV) once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.	Drug: Rapastinel
Rapastinel 450 mg Every 2 Weeks	Experimental	Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.	Drug: Rapastinel
Placebo	Placebo Comparator	Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.	Drug: Placebo-matching Rapastinel

Name	Type	Description	Arm Group Labels	Other Names
Rapastinel	Drug	Rapastinel pre-filled syringes for IV injections.	Rapastinel 450 mg Every 2 Weeks Rapastinel 450 mg Weekly

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period	The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.	52 Weeks
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales	On the C-SSRS, the 5 types of suicidal ideation are: Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"	104 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Time to First Relapse During the Entire Double-Blind Treatment Period	The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.	104 Weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Jenna Hoogerheyde	Allergan	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Harmonex Neuroscience Research

Label	URL
More Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	OLTP Rapastinel 450 mg Weekly + ADT	Rapastinel 450 milligrams (mg) intravenous (IV) once a week during OLTP.
FG001	DBTP Placebo	Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 6, 2018	Feb 21, 2020

Arm/Group Information

ID	Title	Description
BG000	Placebo	Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.
BG001	Rapastinel 450 mg Every 2 Weeks	Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.
BG002	Rapastinel 450 mg Weekly	Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.
BG003	Total	Total of all reporting groups

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
	BG00045.2± 12.45 BG00145.4± 12.17 BG00244.7± 12.15 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000148 BG001142 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00025 BG00129 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG000162 BG001170 BG002

Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00086.49± 19.15 BG00188.29± 18.78 BG002

Height

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG000167.27± 8.85 BG001168.12± 9.78 BG002

BMI

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00030.94± 6.74 BG00131.33± 6.83 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

Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period

The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.

Posted

Median

95% Confidence Interval

Days

52 Weeks

ID	Title	Description
OG000	Placebo	Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.
OG001	Rapastinel 450 mg Every 2 Weeks	Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.
OG002	Rapastinel 450 mg Weekly	Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.

Units	Counts
Participants	OG000202 OG001202 OG002200

Title

Denominators

Categories

Title	Measurements
	OG000232(167 to NA)Not enough events to allow the estimation of the percentiles and the standard error for the confidence intervals. OG001225(127 to 323) OG002336

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
OG000 OG001		Log Rank		0.5305														Superiority
OG000 OG002		Log Rank		0.4628

Secondary

Time to First Relapse During the Entire Double-Blind Treatment Period

The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.

Posted

Median

95% Confidence Interval

Days

104 Weeks

ID	Title	Description
OG000	Placebo	Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.
OG001	Rapastinel 450 mg Every 2 Weeks	Rapastinel 450 mg IV label once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.
OG002	Rapastinel 450 mg Weekly	Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.

Units

Primary

Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales

On the C-SSRS, the 5 types of suicidal ideation are:

Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"

The Double-blind modified Intent-to-Treat Population consists of all patients in the Open-label Safety Population who were randomized to a treatment group during the DBTP of the study and received at least 1 dose of IP during the DBTP. 1 subject in the Biweekly Rapastinel group did not have any responses regarding the C-SSRS during the DBTP.

Posted

Count of Participants

Participants

104 Weeks

ID	Title	Description
OG000	Placebo	Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.
OG001	Rapastinel 450 mg Every 2 Weeks	Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.
OG002	Rapastinel 450 mg Weekly

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	OLTP Rapastinel 450 mg Weekly + ADT	Rapastinel 450 milligrams (mg) intravenous (IV) once a week during OLTP.	0	1,304	26	1,304	290	1,304
EG001	DBTP Placebo	Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.	1	202	6	202	62	202
EG002	DBTP Rapastinel 450 mg Every 2 Weeks	Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks.	0	202	3	202	72	202
EG003	DBTP Rapastinel 450 mg Weekly	Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.	0	200	5	200	66	200

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0002 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG0030 affected200 at risk
Bronchitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0002 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Major depression	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0002 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Pneumonia	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0002 affected1,304 at risk EG0011 affected202 at risk EG0020 affected202 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0002 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0011 affected202 at risk EG0020 affected202 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0011 affected202 at risk EG0020 affected202 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected920 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Lung carcinoma cell type unspecified recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected920 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Procedural vomiting	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Substance abuse	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Substance use disorder	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Traumatic liver injury	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0001 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Device dislocation	Product Issues	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Hypotension	Vascular disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Renal tubular necrosis	Renal and urinary disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Suicidal behaviour	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Suicide threat	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0010 affected202 at risk EG0020 affected202 at risk EG003
Anastomotic ulcer	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0010 affected202 at risk EG0021 affected202 at risk EG003
Breast cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0010 affected202 at risk EG0021 affected202 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0010 affected202 at risk EG0021 affected202 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0011 affected54 at risk EG0020 affected60 at risk EG003
Abscess intestinal	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0011 affected202 at risk EG0020 affected202 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0011 affected202 at risk EG0020 affected202 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0011 affected202 at risk EG0020 affected202 at risk EG003
Altered state of consciousness	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0011 affected202 at risk EG0020 affected202 at risk EG003
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0011 affected202 at risk EG0020 affected202 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0011 affected202 at risk EG0020 affected202 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0011 affected202 at risk EG0020 affected202 at risk EG003
Diverticulitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG0000 affected1,304 at risk EG0011 affected202 at risk EG0020 affected202 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG00079 affected1,304 at risk EG00115 affected202 at risk EG00216 affected202 at risk EG00315 affected200 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG00073 affected1,304 at risk EG00119 affected202 at risk EG00216 affected202 at risk EG003
Headache	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG00096 affected1,304 at risk EG00111 affected202 at risk EG00214 affected202 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA Version 21.1	Systematic Assessment	EG00089 affected1,304 at risk EG0015 affected202 at risk EG00214 affected202 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG00049 affected1,304 at risk EG0015 affected202 at risk EG00211 affected202 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 21.1	Systematic Assessment	EG00041 affected1,304 at risk EG0015 affected202 at risk EG00211 affected202 at risk EG003
Bronchitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG00012 affected1,304 at risk EG0015 affected202 at risk EG0025 affected202 at risk EG003
Sinusitis	Infections and infestations	MedDRA Version 21.1	Systematic Assessment	EG00038 affected1,304 at risk EG00111 affected202 at risk EG0028 affected202 at risk EG003
Weight increased	Investigations	MedDRA Version 21.1	Systematic Assessment	EG00037 affected1,304 at risk EG0014 affected202 at risk EG00211 affected202 at risk EG003
Insomnia	Psychiatric disorders	MedDRA Version 21.1	Systematic Assessment	EG00052 affected1,304 at risk EG00111 affected202 at risk EG00210 affected202 at risk EG003

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders