Trial Outcomes & Findings for Study to Evaluate EB-001 in Reducing Musculoskeletal Pain (NCT NCT03193593)
NCT ID: NCT03193593
Last Updated: 2019-01-25
Results Overview
Subject's assessment of pain using the Numeric Pain Rating Scale (1= No Pain, 10= Maximum Pain) for the first 96 hours following injection, expressed as AUC over the 16h to 96h period following dosing.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
16 hours to 96 hours following dosing
Results posted on
2019-01-25
Participant Flow
Participant milestones
| Measure |
Placebo Injections
Placebo Injection into the Pectoralis Muscle
|
EB-001 Dose 1 (1X)
1st Dose in escalation paradigm.
Injection of active drug into the pectoralis muscle
|
EB-001 Dose 2 (1.6X)
2nd Dose in escalation paradigm, 1.6X Dose 1.
Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 3 (3.3X)
3rd Dose in escalation paradigm, 3.3X Dose 1.
Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 4 (6.7X)
4th Dose in escalation paradigm, 6.7X Dose 1.
Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 5 (10X)
5th Dose in escalation paradigm, 10X Dose 1.
Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 6 (13.3X)
6th Dose in escalation paradigm, 13.3X Dose 1.
Injection of active drug into the pectoralis muscle.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
4
|
4
|
4
|
8
|
16
|
12
|
|
Overall Study
COMPLETED
|
14
|
3
|
3
|
4
|
7
|
13
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
1
|
0
|
1
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate EB-001 in Reducing Musculoskeletal Pain
Baseline characteristics by cohort
| Measure |
Placebo Injections
n=18 Participants
Placebo Injection into the Pectoralis Muscle
|
EB-001 Dose 1 (1X)
n=4 Participants
1st Dose in escalation paradigm.
Single Injection of active drug into the pectoralis muscle
|
EB-001 Dose 2 (1.6X)
n=4 Participants
2nd Dose in escalation paradigm, 1.6X Dose 1.
Single Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 3 (3.3X)
n=4 Participants
3rd Dose in escalation paradigm, 3.3X Dose 1.
Single Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 4 (6.7X)
n=8 Participants
4th Dose in escalation paradigm, 6.7X Dose 1.
Single Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 5 (10X)
n=16 Participants
5th Dose in escalation paradigm, 10X Dose 1.
Single Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 6 (13.3X)
n=12 Participants
6th Dose in escalation paradigm, 13.3X Dose 1.
Single Injection of active drug into the pectoralis muscle.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
26.1 years
STANDARD_DEVIATION 4.66 • n=5 Participants
|
29.5 years
STANDARD_DEVIATION 4.36 • n=7 Participants
|
28.8 years
STANDARD_DEVIATION 6.08 • n=5 Participants
|
27.0 years
STANDARD_DEVIATION 3.37 • n=4 Participants
|
27.3 years
STANDARD_DEVIATION 4.30 • n=21 Participants
|
27.3 years
STANDARD_DEVIATION 3.14 • n=8 Participants
|
27.3 years
STANDARD_DEVIATION 3.14 • n=8 Participants
|
27.6 years
STANDARD_DEVIATION 3.61 • n=24 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
66 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
21 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
42 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
8 participants
n=21 Participants
|
16 participants
n=8 Participants
|
12 participants
n=8 Participants
|
66 participants
n=24 Participants
|
|
BMI
|
22.57 Kg/m^2
STANDARD_DEVIATION 2.596 • n=5 Participants
|
23.95 Kg/m^2
STANDARD_DEVIATION 2.958 • n=7 Participants
|
23.00 Kg/m^2
STANDARD_DEVIATION 3.614 • n=5 Participants
|
22.40 Kg/m^2
STANDARD_DEVIATION 2.848 • n=4 Participants
|
22.66 Kg/m^2
STANDARD_DEVIATION 2.630 • n=21 Participants
|
22.94 Kg/m^2
STANDARD_DEVIATION 2.117 • n=8 Participants
|
23.18 Kg/m^2
STANDARD_DEVIATION 2.474 • n=8 Participants
|
23.00 Kg/m^2
STANDARD_DEVIATION 2.437 • n=24 Participants
|
PRIMARY outcome
Timeframe: 16 hours to 96 hours following dosingPopulation: mITT
Subject's assessment of pain using the Numeric Pain Rating Scale (1= No Pain, 10= Maximum Pain) for the first 96 hours following injection, expressed as AUC over the 16h to 96h period following dosing.
Outcome measures
| Measure |
Placebo Injections
n=18 Participants
Placebo Injection into the Pectoralis Muscle
|
EB-001 Dose 1 (1X)
n=4 Participants
1st Dose in escalation paradigm.
Injection of active drug into the pectoralis muscle
|
EB-001 Dose 2 (1.6X)
n=4 Participants
2nd Dose in escalation paradigm, 1.6X Dose 1.
Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 3 (3.3X)
n=4 Participants
3rd Dose in escalation paradigm, 3.3X Dose 1.
Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 4 (6.7X)
n=8 Participants
4th Dose in escalation paradigm, 6.7X Dose 1.
Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 5 (10X)
n=16 Participants
5th Dose in escalation paradigm, 10X Dose 1.
Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 6 (13.3X)
n=12 Participants
6th Dose in escalation paradigm, 13.3X Dose 1.
Injection of active drug into the pectoralis muscle.
|
|---|---|---|---|---|---|---|---|
|
Subject's Assessment of Pain Using the Numeric Pain Rating Scale (AUC16h-96h)
|
289.18 units on a Scale*hours
Standard Deviation 211.552
|
341.78 units on a Scale*hours
Standard Deviation 124.655
|
401.75 units on a Scale*hours
Standard Deviation 310.509
|
290.55 units on a Scale*hours
Standard Deviation 224.966
|
333.44 units on a Scale*hours
Standard Deviation 217.742
|
381.82 units on a Scale*hours
Standard Deviation 199.401
|
340.89 units on a Scale*hours
Standard Deviation 155.328
|
Adverse Events
Placebo Injections
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
EB-001 Dose 1 (1X)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
EB-001 Dose 2 (1.6X)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
EB-001 Dose 3 (3.3X)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
EB-001 Dose 4 (6.7X)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
EB-001 Dose 5 (10X)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
EB-001 Dose 6 (13.3X)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Injections
n=18 participants at risk
Placebo Injection into the Pectoralis Muscle
|
EB-001 Dose 1 (1X)
n=4 participants at risk
1st Dose in escalation paradigm.
Injection of active drug into the pectoralis muscle
|
EB-001 Dose 2 (1.6X)
n=4 participants at risk
2nd Dose in escalation paradigm, 1.6X Dose 1.
Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 3 (3.3X)
n=4 participants at risk
3rd Dose in escalation paradigm, 3.3X Dose 1.
Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 4 (6.7X)
n=8 participants at risk
4th Dose in escalation paradigm, 6.7X Dose 1.
Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 5 (10X)
n=16 participants at risk
5th Dose in escalation paradigm, 10X Dose 1.
Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 6 (13.3X)
n=12 participants at risk
6th Dose in escalation paradigm, 13.3X Dose 1.
Injection of active drug into the pectoralis muscle.
|
|---|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Breast Hematoma
|
0.00%
0/18 • 30 Days
|
0.00%
0/4 • 30 Days
|
0.00%
0/4 • 30 Days
|
0.00%
0/4 • 30 Days
|
12.5%
1/8 • Number of events 1 • 30 Days
|
0.00%
0/16 • 30 Days
|
0.00%
0/12 • 30 Days
|
Other adverse events
| Measure |
Placebo Injections
n=18 participants at risk
Placebo Injection into the Pectoralis Muscle
|
EB-001 Dose 1 (1X)
n=4 participants at risk
1st Dose in escalation paradigm.
Injection of active drug into the pectoralis muscle
|
EB-001 Dose 2 (1.6X)
n=4 participants at risk
2nd Dose in escalation paradigm, 1.6X Dose 1.
Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 3 (3.3X)
n=4 participants at risk
3rd Dose in escalation paradigm, 3.3X Dose 1.
Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 4 (6.7X)
n=8 participants at risk
4th Dose in escalation paradigm, 6.7X Dose 1.
Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 5 (10X)
n=16 participants at risk
5th Dose in escalation paradigm, 10X Dose 1.
Injection of active drug into the pectoralis muscle.
|
EB-001 Dose 6 (13.3X)
n=12 participants at risk
6th Dose in escalation paradigm, 13.3X Dose 1.
Injection of active drug into the pectoralis muscle.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
72.2%
13/18 • Number of events 13 • 30 Days
|
75.0%
3/4 • Number of events 3 • 30 Days
|
75.0%
3/4 • Number of events 3 • 30 Days
|
100.0%
4/4 • Number of events 4 • 30 Days
|
75.0%
6/8 • Number of events 6 • 30 Days
|
87.5%
14/16 • Number of events 14 • 30 Days
|
50.0%
6/12 • Number of events 6 • 30 Days
|
|
Gastrointestinal disorders
Vomiting
|
27.8%
5/18 • Number of events 5 • 30 Days
|
50.0%
2/4 • Number of events 2 • 30 Days
|
0.00%
0/4 • 30 Days
|
25.0%
1/4 • Number of events 1 • 30 Days
|
62.5%
5/8 • Number of events 5 • 30 Days
|
37.5%
6/16 • Number of events 6 • 30 Days
|
25.0%
3/12 • Number of events 3 • 30 Days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • 30 Days
|
0.00%
0/4 • 30 Days
|
0.00%
0/4 • 30 Days
|
0.00%
0/4 • 30 Days
|
37.5%
3/8 • Number of events 3 • 30 Days
|
12.5%
2/16 • Number of events 2 • 30 Days
|
41.7%
5/12 • Number of events 5 • 30 Days
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1 • 30 Days
|
0.00%
0/4 • 30 Days
|
0.00%
0/4 • 30 Days
|
25.0%
1/4 • Number of events 1 • 30 Days
|
0.00%
0/8 • 30 Days
|
12.5%
2/16 • Number of events 2 • 30 Days
|
8.3%
1/12 • Number of events 1 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.1%
2/18 • Number of events 2 • 30 Days
|
25.0%
1/4 • Number of events 1 • 30 Days
|
25.0%
1/4 • Number of events 1 • 30 Days
|
0.00%
0/4 • 30 Days
|
12.5%
1/8 • Number of events 1 • 30 Days
|
0.00%
0/16 • 30 Days
|
0.00%
0/12 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.6%
1/18 • Number of events 1 • 30 Days
|
0.00%
0/4 • 30 Days
|
50.0%
2/4 • Number of events 2 • 30 Days
|
0.00%
0/4 • 30 Days
|
0.00%
0/8 • 30 Days
|
0.00%
0/16 • 30 Days
|
8.3%
1/12 • Number of events 1 • 30 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place