Trial Outcomes & Findings for Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain (NCT NCT05196919)
NCT ID: NCT05196919
Last Updated: 2025-01-15
Results Overview
Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events (TEAEs) occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
Up to Day 270
Results posted on
2025-01-15
Participant Flow
Participant milestones
| Measure |
0.15mg XT-150
0.15mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
0.45mg XT-150
0.45mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
Placebo
Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Placebo: Phosphate-buffered saline for injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
18
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain
Baseline characteristics by cohort
| Measure |
0.15mg XT-150
n=25 Participants
0.15mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
0.45mg XT-150
n=25 Participants
0.45mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
Placebo
n=25 Participants
Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Placebo: Phosphate-buffered saline for injection
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 9.71 • n=5 Participants
|
58.0 years
STANDARD_DEVIATION 13.11 • n=7 Participants
|
63.6 years
STANDARD_DEVIATION 13.74 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 12.37 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
75 participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
31.0 kg/m2
STANDARD_DEVIATION 6.23 • n=5 Participants
|
31.0 kg/m2
STANDARD_DEVIATION 6.77 • n=7 Participants
|
27.7 kg/m2
STANDARD_DEVIATION 6.44 • n=5 Participants
|
29.9 kg/m2
STANDARD_DEVIATION 6.59 • n=4 Participants
|
PRIMARY outcome
Timeframe: Up to Day 270Population: Safety population
Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events (TEAEs) occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
Outcome measures
| Measure |
0.15mg XT-150
n=25 Participants
0.15mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
0.45mg XT-150
n=25 Participants
0.45mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
Placebo
n=25 Participants
Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Placebo: Phosphate-buffered saline for injection
|
|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs
Related Serious TEAEs · No
|
25 Participants
|
25 Participants
|
25 Participants
|
|
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs
Any TEAEs · Yes
|
11 Participants
|
12 Participants
|
14 Participants
|
|
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs
Any TEAEs · No
|
14 Participants
|
13 Participants
|
11 Participants
|
|
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs
Related TEAEs · Yes
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs
Related TEAEs · No
|
24 Participants
|
24 Participants
|
22 Participants
|
|
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs
Serious TEAEs · Yes
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs
Serious TEAEs · No
|
24 Participants
|
24 Participants
|
25 Participants
|
|
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs
Related Serious TEAEs · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 270Population: Safety population
Hematology and chemistry samples were only collected at Screening and not retested; therefore no results are available for those assessments Abnormal clinically significant physical examination findings were reported as adverse events, as applicable, and not separately reported. Vital signs of temperature, heart rate, respiratory rate and blood pressure were collected at all visits throughout the study.
Outcome measures
| Measure |
0.15mg XT-150
n=25 Participants
0.15mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
0.45mg XT-150
n=25 Participants
0.45mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
Placebo
n=25 Participants
Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Placebo: Phosphate-buffered saline for injection
|
|---|---|---|---|
|
Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs
Day 0 · Abnormal - Not Clinically Significant
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs
Day 0 · Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs
Day 0 · Normal
|
22 Participants
|
24 Participants
|
23 Participants
|
|
Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs
Day 0 · Not Analyzed (Missing Data)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs
Day 270 · Normal
|
15 Participants
|
19 Participants
|
20 Participants
|
|
Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs
Day 270 · Abnormal - Not Clinically Significant
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs
Day 270 · Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Abnormal Hematology and Chemistry Parameters, Physical Examination, and Vital Signs
Day 270 · Not Analyzed (Missing Data)
|
10 Participants
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 270Population: Intent to Treat (ITT) population: All participants who were randomized who received the treatment injection analyzed according to randomized treatment. This was a phase 2a safety study that was not statistically powered for efficacy assessments.
The VAS is 0-100 scale which will be administered to participants via Electronic Patient Reported Outcome (ePRO) at each study visit. The participant will record his/her facet pain level on a scale from 0 (no pain) to 100 (worst pain). Higher scores indicate worse pain intensity.
Outcome measures
| Measure |
0.15mg XT-150
n=15 Participants
0.15mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
0.45mg XT-150
n=20 Participants
0.45mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
Placebo
n=19 Participants
Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Placebo: Phosphate-buffered saline for injection
|
|---|---|---|---|
|
Change From Baseline in Pain Intensity Using 0-100 Visual Analog Scale (VAS)
|
-38.12 score on a scale
Standard Error 6.432
|
-34.37 score on a scale
Standard Error 5.717
|
-42.32 score on a scale
Standard Error 5.811
|
SECONDARY outcome
Timeframe: Day 270Population: Intent to Treat (ITT) population: All participants who were randomized who received the treatment injection analyzed according to randomized treatment. This was a phase 2a safety study that was not statistically powered for efficacy assessments.
The Oswestry Disability Index (ODI) is a 10-item questionnaire to quantify disability for acute or chronic low back pain. Each question is scored on a scale of 0 (least amount of disability) to 5 (most severe disability). Higher scores indicate severe disability.
Outcome measures
| Measure |
0.15mg XT-150
n=15 Participants
0.15mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
0.45mg XT-150
n=20 Participants
0.45mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
Placebo
n=19 Participants
Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Placebo: Phosphate-buffered saline for injection
|
|---|---|---|---|
|
Change From Baseline in Oswestry Disability Index (ODI) Scores
|
-14.4 score on a scale
Standard Error 3.43
|
-3.11 score on a scale
Standard Error 3.104
|
-8.25 score on a scale
Standard Error 3.17
|
SECONDARY outcome
Timeframe: Up to Day 270Population: Intent to Treat (ITT) population: All participants who were randomized who received the treatment injection analyzed according to randomized treatment. This was a phase 2a safety study that was not statistically powered for efficacy assessments.
PGA is used to assess the current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor). Higher score indicates worse symptoms.
Outcome measures
| Measure |
0.15mg XT-150
n=15 Participants
0.15mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
0.45mg XT-150
n=20 Participants
0.45mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
Placebo
n=19 Participants
Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Placebo: Phosphate-buffered saline for injection
|
|---|---|---|---|
|
Change From Baseline in Patient Global Assessment (PGA) Scores
|
-0.6 score on a scale
Standard Deviation 1.55
|
-0.7 score on a scale
Standard Deviation 1.18
|
-0.9 score on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Day 270Population: Intent to Treat (ITT) population: All participants who were randomized who received the treatment injection analyzed according to randomized treatment. This was a phase 2a safety study that was not statistically powered for efficacy assessments.
The globally standardized and validated IPAQ - short form is used to measure self-reported physical activity levels. Four metabolic equivalent tasks (MET) - vigorous, moderate, walking and sitting were included to obtain the physical activity levels from the participants. A higher MET value indicates a higher physical activity level.
Outcome measures
| Measure |
0.15mg XT-150
n=15 Participants
0.15mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
0.45mg XT-150
n=20 Participants
0.45mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
Placebo
n=19 Participants
Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Placebo: Phosphate-buffered saline for injection
|
|---|---|---|---|
|
Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores
Days vigorous physical activity during last 7 days
|
0.7 days
Standard Deviation 2.43
|
-0.6 days
Standard Deviation 1.64
|
-0.3 days
Standard Deviation 1.06
|
|
Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores
Days moderate physical activity during last 7 days
|
1.5 days
Standard Deviation 3.44
|
-0.6 days
Standard Deviation 3.45
|
0.2 days
Standard Deviation 3.08
|
|
Change From Baseline in International Physical Activity Questionnaire (IPAQ Short Form) Scores
Days walking at least 10 minutes during last 7 days
|
0.9 days
Standard Deviation 2.64
|
-0.8 days
Standard Deviation 3.07
|
-0.5 days
Standard Deviation 3.27
|
Adverse Events
0.15mg XT-150
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
0.45mg XT-150
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.15mg XT-150
n=25 participants at risk
0.15mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
0.45mg XT-150
n=25 participants at risk
0.45mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
Placebo
n=25 participants at risk
Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Placebo: Phosphate-buffered saline for injection
|
|---|---|---|---|
|
Vascular disorders
Aortic Dissection
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
0.00%
0/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
0.00%
0/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large B-cell lymphoma
|
0.00%
0/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
4.0%
1/25 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
0.00%
0/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
Other adverse events
| Measure |
0.15mg XT-150
n=25 participants at risk
0.15mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
0.45mg XT-150
n=25 participants at risk
0.45mg XT-150 administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
XT-150: XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.
|
Placebo
n=25 participants at risk
Placebo administered in 1.0 mL total delivered by two 0.5 mL injections on Day 0 and Day 90.
Placebo: Phosphate-buffered saline for injection
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
20.0%
5/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
4.0%
1/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
16.0%
4/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
|
Infections and infestations
Influenza
|
8.0%
2/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
0.00%
0/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
0.00%
0/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
2/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
0.00%
0/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
0.00%
0/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
4.0%
1/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
4.0%
1/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
4.0%
1/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
4.0%
1/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
12.0%
3/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
8.0%
2/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
20.0%
5/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
20.0%
5/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
12.0%
3/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
0.00%
0/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
8.0%
2/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
4.0%
1/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
4.0%
1/25 • Adverse events were collected from the time of informed consent through the last study visit on Day 270 (9 months). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 270) or early termination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI is bound to terms and conditions of a Sponsored Clinical Trial Agreement which has strict confidentiality obligations running to Sponsor and broad provisions restricting PI's rights to publish or present any data or Study Results without Sponsor's express review consent and review.
- Publication restrictions are in place
Restriction type: OTHER