Trial Outcomes & Findings for Open Label Extension for GLYX13-C-202, NCT01684163 (NCT NCT02192099)
NCT ID: NCT02192099
Last Updated: 2019-11-27
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
48 Months
Results posted on
2019-11-27
Participant Flow
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.
Participant milestones
| Measure |
Rapastinel (GLYX-13) 225mg or 450 mg IV Administration
Rapastinel (225 mg/450 mg intravenous \[IV\] administration), prefilled syringe.
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
61
|
Reasons for withdrawal
| Measure |
Rapastinel (GLYX-13) 225mg or 450 mg IV Administration
Rapastinel (225 mg/450 mg intravenous \[IV\] administration), prefilled syringe.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Protocol Violation
|
8
|
|
Overall Study
Study Terminated by Sponsor
|
32
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Miscellaneous Reasons
|
5
|
Baseline Characteristics
Open Label Extension for GLYX13-C-202, NCT01684163
Baseline characteristics by cohort
| Measure |
Rapastinel (GLYX-13) 225mg or 450 mg IV Administration
n=61 Participants
Rapastinel (225 mg/450 mg intravenous \[IV\] administration), prefilled syringe.
|
|---|---|
|
Age, Continuous
|
49.4 Years
STANDARD_DEVIATION 10.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 MonthsPopulation: The Safety Population will consist of all subjects who received any injection of study drug.
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.
Outcome measures
| Measure |
Rapastinel (GLYX-13) 225mg or 450 mg IV Administration
n=61 Participants
Rapastinel (225 mg/450 mg intravenous \[IV\] administration), prefilled syringe.
|
|---|---|
|
The Number of Participants Who Experience an Adverse Event Over the Course of the Study.
|
60 Participants
|
Adverse Events
Rapastinel (GLYX-13) 225mg or 450 mg IV Administration
Serious events: 14 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rapastinel (GLYX-13) 225mg or 450 mg IV Administration
n=61 participants at risk
Rapastinel (225 mg/450 mg intravenous \[IV\] administration), prefilled syringe.
|
|---|---|
|
Psychiatric disorders
Drug use disorder
|
3.3%
2/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Nervous system disorders
Seizure
|
3.3%
2/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Infections and infestations
Appendicitis
|
1.6%
1/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Infections and infestations
Arthritis bacterial
|
1.6%
1/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Infections and infestations
Cellulitis
|
1.6%
1/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Gastrointestinal disorders
Colitis
|
1.6%
1/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Injury, poisoning and procedural complications
Delayed recovery from anaesthesia
|
1.6%
1/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Psychiatric disorders
Depression
|
1.6%
1/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
1.6%
1/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
1.6%
1/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Nervous system disorders
Hemiparesis
|
1.6%
1/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Nervous system disorders
Lacunar stroke
|
1.6%
1/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
1.6%
1/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Infections and infestations
Pneumonia
|
1.6%
1/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Infections and infestations
Pyelonephritis
|
1.6%
1/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.6%
1/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.6%
1/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Injury, poisoning and procedural complications
Ureteric injury
|
1.6%
1/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Gastrointestinal disorders
Volvulus of small bowel
|
1.6%
1/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
Other adverse events
| Measure |
Rapastinel (GLYX-13) 225mg or 450 mg IV Administration
n=61 participants at risk
Rapastinel (225 mg/450 mg intravenous \[IV\] administration), prefilled syringe.
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
54.1%
33/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Nervous system disorders
Headache
|
50.8%
31/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
45.9%
28/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Gastrointestinal disorders
Nausea
|
39.3%
24/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.2%
16/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
26.2%
16/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Psychiatric disorders
Insomnia
|
23.0%
14/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
21.3%
13/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Psychiatric disorders
Anxiety
|
19.7%
12/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Gastrointestinal disorders
Constipation
|
19.7%
12/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.0%
11/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.0%
11/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.0%
11/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Infections and infestations
Sinusitis
|
18.0%
11/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Infections and infestations
Gastroenteritis
|
16.4%
10/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Infections and infestations
Influenza
|
16.4%
10/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.4%
10/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.4%
10/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
General disorders
Fatigue
|
14.8%
9/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.1%
8/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Psychiatric disorders
Depression
|
13.1%
8/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
13.1%
8/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Nervous system disorders
Dizziness
|
11.5%
7/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
9.8%
6/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
11.5%
7/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Nervous system disorders
Migraine
|
11.5%
7/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
9.8%
6/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Psychiatric disorders
Irritability
|
9.8%
6/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
9.8%
6/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.8%
6/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Infections and infestations
Pharyngitis
|
9.8%
6/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Investigations
Weight increased
|
9.8%
6/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
8.2%
5/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
8.2%
5/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Investigations
Blood pressure increased
|
8.2%
5/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Infections and infestations
Bronchitis
|
8.2%
5/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
8.2%
5/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.2%
5/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.2%
5/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
8.2%
5/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
8.2%
5/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.2%
5/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Gastrointestinal disorders
Toothache
|
8.2%
5/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Infections and infestations
Urinary tract infection
|
8.2%
5/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
8.2%
5/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.6%
4/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.6%
4/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Infections and infestations
Ear infection
|
6.6%
4/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Eye disorders
Eye irritation
|
6.6%
4/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
6.6%
4/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Vascular disorders
Hypertension
|
6.6%
4/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Metabolism and nutrition disorders
Increased appetite
|
6.6%
4/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.6%
4/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.6%
4/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
General disorders
Oedema peripheral
|
6.6%
4/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.6%
4/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
6.6%
4/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Immune system disorders
Seasonal allergy
|
6.6%
4/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.6%
4/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
6.6%
4/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Investigations
Weight decreased
|
6.6%
4/61 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
6.5%
3/46 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.7%
1/15 • Adverse Events were collected for up to 48 months.
The Safety Population will consist of all subjects who received any injection of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER