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Patients from this study were rolled into RAP-MD-99.
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Examine the safety of long term repeat exposure to GLYX-13 in subjects who participated in GLYX13-C-202.
Examine the safety of long term repeat exposure to GLYX-13 in subjects who participated in GLYX13-C-202 in an open label extension trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapastinel (225 mg/450 mg IV administration) prefilled syringe | Experimental | Investigators began treatment in RAP-MD-05 based on the dose level to which the patient was assigned during participation in GLYX13-C-202; patients originally assigned to rapastinel 5 mg/kg received rapastinel 225 mg, and patients originally assigned to rapastinel 10 mg/kg received rapastinel 450 mg. Investigators had the option to decrease the dose level from 450 to 225 mg if a patient experienced an adverse event(s) that the investigator believed may be associated with rapastinel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapastinel (225 mg/450 mg IV administration) | Drug | Investigators began treatment in RAP-MD-05 based on the dose level to which the patient was assigned during participation in GLYX13-C-202; patients originally assigned to rapastinel 5 mg/kg received rapastinel 225 mg, and patients originally assigned to rapastinel 10 mg/kg received rapastinel 450 mg. Investigators had the option to decrease the dose level from 450 to 225 mg if a patient experienced an adverse event(s) that the investigator believed may be associated with rapastinel |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Who Experience an Adverse Event Over the Course of the Study. | An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period. | 48 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jenna Hoogerheyde | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Office of Psychiatric Research | Birmingham | Alabama | 35294 | United States | ||
| Artemis Institute for Clinical Research |
Outpatients who have completed 8 or more weeks of treatment in the preceding study (GLYX13-C-202) and were willing to continue treatment with rapastinel (GLYX-13). Patients originally assigned to rapastinel 5 mg/kg received rapastinel 225 mg, and patients originally assigned to rapastinel 10 mg/kg received rapastinel 450 mg.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rapastinel (GLYX-13) 225mg or 450 mg IV Administration | Rapastinel (225 mg/450 mg intravenous [IV] administration), prefilled syringe. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Population will consist of all subjects who received any injection of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rapastinel (GLYX-13) 225mg or 450 mg IV Administration | Rapastinel (225 mg/450 mg intravenous [IV] administration), prefilled syringe. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Number of Participants Who Experience an Adverse Event Over the Course of the Study. | An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period. | The Safety Population will consist of all subjects who received any injection of study drug. | Posted | Number | Participants | 48 Months |
|
Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
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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 | Rapastinel (GLYX-13) 225mg or 450 mg IV Administration | Rapastinel (225 mg/450 mg intravenous [IV] administration), prefilled syringe. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug use disorder | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | IR-CTRegistration@allergan.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 23, 2016 | Nov 8, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2018 | Nov 8, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C507283 | GLYX-13 peptide |
| D009934 | Organization and Administration |
| ID | Term |
|---|---|
| D006298 | Health Services Administration |
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|
|
| San Diego |
| California |
| 92103 |
| United States |
| Chicago Research Center | Chicago | Illinois | 60634 | United States |
| University of Kansas School of Medicine Clinical Trial Unit | Wichita | Kansas | 67214 | United States |
| PharmaSite Research, Inc. | Baltimore | Maryland | 21208 | United States |
| Boston Clinical Trials Inc. | Roslindale | Massachusetts | 02131 | United States |
| Woodlands Professional Princeton Medical Institute Building | Princeton | New Jersey | 08540 | United States |
| Finger Lake Clinical Research | Rochester | New York | 14618 | United States |
| Lindner Center of HOPE | Mason | Ohio | 45040 | United States |
| PRA Health Sciences Phase 2/3 Outpatient & CNS Clinic | Salt Lake City | Utah | 84107 | United States |
| Pregnancy |
|
| Protocol Violation |
|
| Study Terminated by Sponsor |
|
| Withdrawal by Subject |
|
| Miscellaneous Reasons |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 61 |
| 14 |
| 61 |
| 60 |
| 61 |
| Seizure | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Delayed recovery from anaesthesia | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Lacunar stroke | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Ureteric injury | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Volvulus of small bowel | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA Version 20.0 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.