Trial Outcomes & Findings for A Study to Evaluate Safety and Exploratory Efficacy of KTP-001 in Subjects With Lumbar Disc Herniation (NCT NCT01978912)
NCT ID: NCT01978912
Last Updated: 2020-02-11
Results Overview
Any clinically significant changes were recorded as adverse events. They are described in the adverse events section of the results. AEs related to MRI, X-ray Imaging, Physical examination, and Neurologic examination are considered as adverse events of special interest (AESI). A treatment-emergent AE (TEAE) was defined as an AE that was not present prior to treatment with study drug, but appeared following treatment or was present at treatment initiation but worsened in severity during treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
24 months
Results posted on
2020-02-11
Participant Flow
Participant milestones
| Measure |
Cohort 1 KTP-001 5 μg/Disc
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 2 KTP-001 15 μg/Disc
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 3 KTP-001 50 μg/Disc
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 4 KTP-001 150 μg/Disc
KTP-001: KTP-001 is one time dose intradiscally.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
3
|
Reasons for withdrawal
| Measure |
Cohort 1 KTP-001 5 μg/Disc
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 2 KTP-001 15 μg/Disc
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 3 KTP-001 50 μg/Disc
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 4 KTP-001 150 μg/Disc
KTP-001: KTP-001 is one time dose intradiscally.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
2
|
|
Overall Study
Lumbar Surgery
|
1
|
0
|
1
|
0
|
|
Overall Study
Intradiscal Steroid Injection
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate Safety and Exploratory Efficacy of KTP-001 in Subjects With Lumbar Disc Herniation
Baseline characteristics by cohort
| Measure |
Cohort 1 KTP-001 5 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 2 KTP-001 15 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 3 KTP-001 50 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 4 KTP-001 150 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.3 years
STANDARD_DEVIATION 3.33 • n=93 Participants
|
49.0 years
STANDARD_DEVIATION 8.90 • n=4 Participants
|
52.2 years
STANDARD_DEVIATION 13.23 • n=27 Participants
|
47.0 years
STANDARD_DEVIATION 9.49 • n=483 Participants
|
46.1 years
STANDARD_DEVIATION 10.68 • n=36 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
20 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 24 monthsAny clinically significant changes were recorded as adverse events. They are described in the adverse events section of the results. AEs related to MRI, X-ray Imaging, Physical examination, and Neurologic examination are considered as adverse events of special interest (AESI). A treatment-emergent AE (TEAE) was defined as an AE that was not present prior to treatment with study drug, but appeared following treatment or was present at treatment initiation but worsened in severity during treatment.
Outcome measures
| Measure |
Cohort 1 KTP-001 5 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 2 KTP-001 15 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 3 KTP-001 50 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 4 KTP-001 150 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
|---|---|---|---|---|
|
Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs
Participants with any AEs
|
6 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
|
Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs
Participants with any TEAEs
|
6 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
|
Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs
Participants with any serious TEAEs
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs
Participants with any AESIs
|
4 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs
TEAEs leading to study discontinuation
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 13 weeksAssessment of the number of participants with change in 12-lead ECG and CLT were assessed from baseline, 24 hours and 13 weeks.
Outcome measures
| Measure |
Cohort 1 KTP-001 5 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 2 KTP-001 15 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 3 KTP-001 50 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 4 KTP-001 150 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
|---|---|---|---|---|
|
Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT)
Participants with abnormal changes in ECG
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT)
Participants without abnormal CL
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT)
Participants without abnormal changes in ECG
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT)
Participants with abnormal CLT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 13 weeksThe serum concentrations of KTP-001 were below the limit of quantification (BLQ) (\<100 ng/mL) at all time points in all participants
Outcome measures
| Measure |
Cohort 1 KTP-001 5 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 2 KTP-001 15 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 3 KTP-001 50 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 4 KTP-001 150 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
|---|---|---|---|---|
|
Number of Participants Serum Concentrations of KTP-001 Below the Limit of Quantification (BLQ)
BLQ during the study up to 13 weeks
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants Serum Concentrations of KTP-001 Below the Limit of Quantification (BLQ)
Not BLQ during the study up to 13 weeks
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 13 weeksOutcome measures
| Measure |
Cohort 1 KTP-001 5 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 2 KTP-001 15 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 3 KTP-001 50 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 4 KTP-001 150 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
|---|---|---|---|---|
|
Number of Participants With Anti-KTP-001 Antibody
Negative during the study up to 13 weeks
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Anti-KTP-001 Antibody
Positive during the study up to 13 weeks
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 weeks and 13 weeks post-dosePopulation: The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.
Lower back and leg pain were assessed using an 11-point numerical rating scale (0 = "no pain" and 10 = "worst possible pain"). The endpoint was mean change from baseline at 6 and 13 weeks post-dose; with a negative number suggesting an improvement in pain while a positive number suggests a worsening in pain.
Outcome measures
| Measure |
Cohort 1 KTP-001 5 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 2 KTP-001 15 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 3 KTP-001 50 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 4 KTP-001 150 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
|---|---|---|---|---|
|
Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale
Change in Current Low Back Pain at Week 13
|
-2.4 score on a scale
Standard Deviation 2.61
|
-3.7 score on a scale
Standard Deviation 3.01
|
-2.3 score on a scale
Standard Deviation 4.18
|
-2.8 score on a scale
Standard Deviation 2.28
|
|
Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale
Change in Low Back Average Daily Pain at Week 6
|
-3.64 score on a scale
Standard Deviation 3.587
|
-3.97 score on a scale
Standard Deviation 2.448
|
-3.36 score on a scale
Standard Deviation 2.674
|
-3.84 score on a scale
Standard Deviation 2.551
|
|
Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale
Change in Low Back Worst Daily Pain at Week 6
|
-3.72 score on a scale
Standard Deviation 3.984
|
-4.27 score on a scale
Standard Deviation 3.066
|
-3.64 score on a scale
Standard Deviation 3.018
|
-3.88 score on a scale
Standard Deviation 2.488
|
|
Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale
Change in Low Back Worst Daily Pain at Week 13
|
-2.90 score on a scale
Standard Deviation 2.928
|
-4.96 score on a scale
Standard Deviation 3.303
|
-2.43 score on a scale
Standard Deviation 3.829
|
-2.90 score on a scale
Standard Deviation 1.089
|
|
Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale
Change in Current Low Back Pain at Week 6
|
-3.6 score on a scale
Standard Deviation 2.97
|
-4.0 score on a scale
Standard Deviation 2.28
|
-3.2 score on a scale
Standard Deviation 3.90
|
-3.8 score on a scale
Standard Deviation 1.79
|
|
Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale
Change in Low Back Average Daily Pain at Week 13
|
-3.27 score on a scale
Standard Deviation 2.919
|
-4.36 score on a scale
Standard Deviation 2.787
|
-2.17 score on a scale
Standard Deviation 3.572
|
-4.30 score on a scale
Standard Deviation 1.669
|
|
Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale
Change in Current Leg Pain at Week 6
|
-2.8 score on a scale
Standard Deviation 3.42
|
-4.2 score on a scale
Standard Deviation 1.83
|
-4.2 score on a scale
Standard Deviation 3.96
|
-4.4 score on a scale
Standard Deviation 2.70
|
|
Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale
Change in Current Leg Pain at Week 13
|
-3.4 score on a scale
Standard Deviation 3.05
|
-5.2 score on a scale
Standard Deviation 1.83
|
-3.8 score on a scale
Standard Deviation 3.87
|
-4.4 score on a scale
Standard Deviation 3.13
|
|
Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale
Change in Leg Average Daily Pain at Week 6
|
-2.66 score on a scale
Standard Deviation 3.669
|
-4.83 score on a scale
Standard Deviation 1.515
|
-3.76 score on a scale
Standard Deviation 2.985
|
-4.00 score on a scale
Standard Deviation 3.476
|
|
Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale
Change in Leg Average Daily Pain at Week13
|
-2.63 score on a scale
Standard Deviation 3.053
|
-5.28 score on a scale
Standard Deviation 1.145
|
-4.20 score on a scale
Standard Deviation 2.647
|
-5.70 score on a scale
Standard Deviation 1.669
|
|
Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale
Change in Leg Worst Daily Pain at Week 6
|
-2.34 score on a scale
Standard Deviation 3.449
|
-4.93 score on a scale
Standard Deviation 2.355
|
-4.12 score on a scale
Standard Deviation 3.239
|
-3.72 score on a scale
Standard Deviation 3.294
|
|
Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale
Change in Leg Worst Daily Pain at Week13
|
-2.30 score on a scale
Standard Deviation 3.074
|
-5.60 score on a scale
Standard Deviation 2.159
|
-4.23 score on a scale
Standard Deviation 2.986
|
-5.40 score on a scale
Standard Deviation 1.275
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 weeks and 13 weeks post-doseThe changes to spinal flexion and tension were assessed using Straight-Leg Rising (SLR) and Femoral Stretch (FS) tests which are on a scale of no change, positive to negative or negative to positive and where a positive result for SLR may indicate between 30 and 70 degrees, where a positive result for FS may indicate pain in the anterior thigh of the test leg and the elicited pain.
Outcome measures
| Measure |
Cohort 1 KTP-001 5 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 2 KTP-001 15 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 3 KTP-001 50 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 4 KTP-001 150 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
|---|---|---|---|---|
|
Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test
Straight-Leg Raising Test at Week 6 · Missing
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test
Straight-Leg Raising Test at Week 13 · No change
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test
Femoral Stretch Test at Week 13 · Positive to Negative
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test
Straight-Leg Raising Test at Week 6 · Positive to Negative
|
3 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test
Straight-Leg Raising Test at Week 6 · Negative to Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test
Straight-Leg Raising Test at Week 6 · No change
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test
Straight-Leg Raising Test at Week 13 · Positive to Negative
|
4 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test
Straight-Leg Raising Test at Week 13 · Negative to Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test
Straight-Leg Raising Test at Week 13 · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test
Femoral Stretch Test at Week 6 · Positive to Negative
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test
Femoral Stretch Test at Week 6 · Negative to Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test
Femoral Stretch Test at Week 6 · No change
|
5 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test
Femoral Stretch Test at Week 6 · Missing
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test
Femoral Stretch Test at Week 13 · Negative to Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test
Femoral Stretch Test at Week 13 · No change
|
5 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test
Femoral Stretch Test at Week 13 · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 weeks and 13 weeks post-dosePopulation: The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.
The Oswestry Disability Index (ODI) score is calculated as participant score divided by possible score multiplied by 100, where the following scores can be interpreted to indicate: 0-20% = Minimal disability; 20-40% = Moderate disability; 40-60% = Severe disability; 60-80% = Crippled; 80-100% = Bed bound;
Outcome measures
| Measure |
Cohort 1 KTP-001 5 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 2 KTP-001 15 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 3 KTP-001 50 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 4 KTP-001 150 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
|---|---|---|---|---|
|
Number of Participants With Changes in the Oswestry Disability Index
Baseline · 80-100 Bedbound
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in the Oswestry Disability Index
Week 13 · 60-80 Crippled
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in the Oswestry Disability Index
Baseline · 0-20 Minimal Disability
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in the Oswestry Disability Index
Baseline · 20-40 Moderate Disability
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Changes in the Oswestry Disability Index
Baseline · 40-60 Severe Disability
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Changes in the Oswestry Disability Index
Baseline · 60-80 Crippled
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Changes in the Oswestry Disability Index
Baseline · missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in the Oswestry Disability Index
Week 6 · 0-20 Minimal Disability
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Changes in the Oswestry Disability Index
Week 6 · 20-40 Moderate Disability
|
2 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Changes in the Oswestry Disability Index
Week 6 · 40-60 Severe Disability
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in the Oswestry Disability Index
Week 6 · 60-80 Crippled
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in the Oswestry Disability Index
Week 6 · 80-100 Bedbound
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in the Oswestry Disability Index
Week 6 · missing
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Changes in the Oswestry Disability Index
Week 13 · 0-20 Minimal Disability
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Changes in the Oswestry Disability Index
Week 13 · 20-40 Moderate Disability
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Changes in the Oswestry Disability Index
Week 13 · 40-60 Severe Disability
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Changes in the Oswestry Disability Index
Week 13 · 80-100 Bedbound
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in the Oswestry Disability Index
Week 13 · missing
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 weeks and 13 weeks post-dosePopulation: The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.
The endpoint was change from baseline at Week 6 and 13 hours post-dose. The Short Form-12 (SF-12) is a Quality of Life questionnaire which measures functional health and well-being from a participant's perspective across eight health domains. Each participant answers questions on a 5-point Likert scale, which rates responses according to how much the participant agrees or disagrees with a particular statement on their health and wellbeing, including vitality/physical functioning/bodily pain/general health perceptions/physical role functioning/emotional role functioning/social role functioning and mental health. Each scale is transformed into a 0-100 scale, assuming each question carries equal weight. Lower scores mean greater disability and higher scores mean less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Cohort 1 KTP-001 5 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 2 KTP-001 15 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 3 KTP-001 50 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 4 KTP-001 150 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
|---|---|---|---|---|
|
Changes in Quality of Life as Assessed by Short Form-12 (SF-12)
Change in General Health score at Week 13
|
0.000 score on a scale
Standard Deviation 0.0000
|
-0.042 score on a scale
Standard Deviation 0.1021
|
-0.167 score on a scale
Standard Deviation 0.1291
|
-0.100 score on a scale
Standard Deviation 0.1369
|
|
Changes in Quality of Life as Assessed by Short Form-12 (SF-12)
Change in Social Functioning score at Week 6
|
0.100 score on a scale
Standard Deviation 0.2850
|
0.292 score on a scale
Standard Deviation 0.2923
|
0.250 score on a scale
Standard Deviation 0.2500
|
0.300 score on a scale
Standard Deviation 0.2092
|
|
Changes in Quality of Life as Assessed by Short Form-12 (SF-12)
Change in Role Emotional score at Week 6
|
0.1000 score on a scale
Standard Deviation 0.34686
|
0.2292 score on a scale
Standard Deviation 0.25516
|
0.2500 score on a scale
Standard Deviation 0.19764
|
0.1750 score on a scale
Standard Deviation 0.31375
|
|
Changes in Quality of Life as Assessed by Short Form-12 (SF-12)
Change in Physical Functioning score at Week 6
|
0.400 score on a scale
Standard Deviation 0.4183
|
0.333 score on a scale
Standard Deviation 0.3028
|
0.400 score on a scale
Standard Deviation 0.4183
|
0.200 score on a scale
Standard Deviation 0.2092
|
|
Changes in Quality of Life as Assessed by Short Form-12 (SF-12)
Change in Physical Functioning score at Week 13
|
0.208 score on a scale
Standard Deviation 0.2458
|
0.500 score on a scale
Standard Deviation 0.3162
|
0.333 score on a scale
Standard Deviation 0.5401
|
0.250 score on a scale
Standard Deviation 0.2500
|
|
Changes in Quality of Life as Assessed by Short Form-12 (SF-12)
Change in Role Physical score at Week 6
|
0.2500 score on a scale
Standard Deviation 0.35355
|
0.2292 score on a scale
Standard Deviation 0.27858
|
0.3000 score on a scale
Standard Deviation 0.20917
|
0.2250 score on a scale
Standard Deviation 0.31125
|
|
Changes in Quality of Life as Assessed by Short Form-12 (SF-12)
Change in Role Physical score at Week 13
|
0.1667 score on a scale
Standard Deviation 0.23274
|
0.2083 score on a scale
Standard Deviation 0.32275
|
0.3333 score on a scale
Standard Deviation 0.41583
|
0.3750 score on a scale
Standard Deviation 0.15309
|
|
Changes in Quality of Life as Assessed by Short Form-12 (SF-12)
Change in Bodily Pain score at Week 6
|
-0.100 score on a scale
Standard Deviation 0.3791
|
-0.417 score on a scale
Standard Deviation 0.2041
|
-0.300 score on a scale
Standard Deviation 0.2739
|
-0.350 score on a scale
Standard Deviation 0.1369
|
|
Changes in Quality of Life as Assessed by Short Form-12 (SF-12)
Change in Bodily Pain score at Week 13
|
-0.167 score on a scale
Standard Deviation 0.3764
|
-0.417 score on a scale
Standard Deviation 0.2041
|
-0.333 score on a scale
Standard Deviation 0.3028
|
-0.400 score on a scale
Standard Deviation 0.2850
|
|
Changes in Quality of Life as Assessed by Short Form-12 (SF-12)
Change in General Health score at Week 6
|
0.000 score on a scale
Standard Deviation 0.0000
|
0.042 score on a scale
Standard Deviation 0.1021
|
-0.100 score on a scale
Standard Deviation 0.1369
|
-0.150 score on a scale
Standard Deviation 0.1369
|
|
Changes in Quality of Life as Assessed by Short Form-12 (SF-12)
Change in Vitality score at Week 6
|
-0.100 score on a scale
Standard Deviation 0.2236
|
-0.167 score on a scale
Standard Deviation 0.1291
|
0.050 score on a scale
Standard Deviation 0.2092
|
-0.250 score on a scale
Standard Deviation 0.2500
|
|
Changes in Quality of Life as Assessed by Short Form-12 (SF-12)
Change in Vitality score at Week 13
|
0.000 score on a scale
Standard Deviation 0.3162
|
-0.125 score on a scale
Standard Deviation 0.1369
|
-0.042 score on a scale
Standard Deviation 0.2923
|
-0.200 score on a scale
Standard Deviation 0.2739
|
|
Changes in Quality of Life as Assessed by Short Form-12 (SF-12)
Change in Social Functioning score at Week 13
|
0.125 score on a scale
Standard Deviation 0.2092
|
0.333 score on a scale
Standard Deviation 0.3028
|
0.333 score on a scale
Standard Deviation 0.3764
|
0.400 score on a scale
Standard Deviation 0.2850
|
|
Changes in Quality of Life as Assessed by Short Form-12 (SF-12)
Change in Role Emotional score at Week 13
|
0.1875 score on a scale
Standard Deviation 0.27099
|
0.3542 score on a scale
Standard Deviation 0.30017
|
0.2083 score on a scale
Standard Deviation 0.20412
|
0.2750 score on a scale
Standard Deviation 0.32355
|
|
Changes in Quality of Life as Assessed by Short Form-12 (SF-12)
Change in Mental Health score at Week 6
|
0.0000 score on a scale
Standard Deviation 0.08839
|
0.0625 score on a scale
Standard Deviation 0.06847
|
0.0250 score on a scale
Standard Deviation 0.13693
|
-0.0500 score on a scale
Standard Deviation 0.22707
|
|
Changes in Quality of Life as Assessed by Short Form-12 (SF-12)
Change in Mental Health score at Week 13
|
-0.0417 score on a scale
Standard Deviation 0.06455
|
0.1667 score on a scale
Standard Deviation 0.21890
|
0.0208 score on a scale
Standard Deviation 0.14613
|
0.0250 score on a scale
Standard Deviation 0.16298
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 weeks and 13 weeks post-dosePopulation: The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.
The Patient Global Impression Change PGI-C scale was used where the scale ranges are from 1 (no change or condition has got worse) to 7 (a great deal better, and a considerable improvement). The endpoint was the value at 6 and 13 weeks post-dose.
Outcome measures
| Measure |
Cohort 1 KTP-001 5 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 2 KTP-001 15 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 3 KTP-001 50 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 4 KTP-001 150 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
|---|---|---|---|---|
|
Patient Global Impression of Change (PGI-C)
Week 6
|
4.4 score on a scale
Standard Deviation 3.78
|
2.3 score on a scale
Standard Deviation 1.37
|
3.2 score on a scale
Standard Deviation 3.27
|
2.2 score on a scale
Standard Deviation 1.64
|
|
Patient Global Impression of Change (PGI-C)
Week 13
|
4.7 score on a scale
Standard Deviation 2.34
|
2.2 score on a scale
Standard Deviation 1.17
|
3.3 score on a scale
Standard Deviation 3.27
|
2.8 score on a scale
Standard Deviation 2.39
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 and 24 hours and 1, 2, 4, 6 weeks and 13 weeks post-dosePopulation: The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.
The endpoint was change from baseline at 6 and 24 hours post-dose, and at the 1-, 2-, 4-, 6-, and 13-week follow-up visits or early termination visit.
Outcome measures
| Measure |
Cohort 1 KTP-001 5 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 2 KTP-001 15 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 3 KTP-001 50 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 4 KTP-001 150 μg/Disc
n=6 Participants
KTP-001: KTP-001 is one time dose intradiscally.
|
|---|---|---|---|---|
|
Changes in Serum Concentrations of Keratan Sulfate
6 hours
|
-93.7 ng/ml
Standard Deviation 59.22
|
-84.7 ng/ml
Standard Deviation 47.24
|
-37.3 ng/ml
Standard Deviation 42.28
|
-24.8 ng/ml
Standard Deviation 49.68
|
|
Changes in Serum Concentrations of Keratan Sulfate
24 hours
|
-39.2 ng/ml
Standard Deviation 87.90
|
-73.2 ng/ml
Standard Deviation 34.59
|
35.2 ng/ml
Standard Deviation 72.37
|
141.8 ng/ml
Standard Deviation 262.07
|
|
Changes in Serum Concentrations of Keratan Sulfate
Week 1
|
77.3 ng/ml
Standard Deviation 30.66
|
47.2 ng/ml
Standard Deviation 47.31
|
117.7 ng/ml
Standard Deviation 41.31
|
297.3 ng/ml
Standard Deviation 144.99
|
|
Changes in Serum Concentrations of Keratan Sulfate
Week 2
|
47.0 ng/ml
Standard Deviation 62.77
|
22.2 ng/ml
Standard Deviation 81.96
|
102.0 ng/ml
Standard Deviation 69.13
|
173.2 ng/ml
Standard Deviation 120.44
|
|
Changes in Serum Concentrations of Keratan Sulfate
Week 4
|
-6.2 ng/ml
Standard Deviation 45.44
|
-36.7 ng/ml
Standard Deviation 66.22
|
87.2 ng/ml
Standard Deviation 49.60
|
26.8 ng/ml
Standard Deviation 79.08
|
|
Changes in Serum Concentrations of Keratan Sulfate
Week 6
|
1.4 ng/ml
Standard Deviation 74.31
|
-41.7 ng/ml
Standard Deviation 69.84
|
64.0 ng/ml
Standard Deviation 61.46
|
11.0 ng/ml
Standard Deviation 81.86
|
|
Changes in Serum Concentrations of Keratan Sulfate
Week 13
|
-7.5 ng/ml
Standard Deviation 127.30
|
-39.2 ng/ml
Standard Deviation 63.90
|
55.8 ng/ml
Standard Deviation 83.71
|
-13.6 ng/ml
Standard Deviation 43.64
|
Adverse Events
Cohort 1 KTP-001 5 μg/Disc
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2 KTP-001 15 μg/Disc
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 3 KTP-001 50 μg/Disc
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 4 KTP-001 150 μg/Disc
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 KTP-001 5 μg/Disc
n=6 participants at risk
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 2 KTP-001 15 μg/Disc
n=6 participants at risk
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 3 KTP-001 50 μg/Disc
n=6 participants at risk
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 4 KTP-001 150 μg/Disc
n=6 participants at risk
KTP-001: KTP-001 is one time dose intradiscally.
|
|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
Other adverse events
| Measure |
Cohort 1 KTP-001 5 μg/Disc
n=6 participants at risk
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 2 KTP-001 15 μg/Disc
n=6 participants at risk
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 3 KTP-001 50 μg/Disc
n=6 participants at risk
KTP-001: KTP-001 is one time dose intradiscally.
|
Cohort 4 KTP-001 150 μg/Disc
n=6 participants at risk
KTP-001: KTP-001 is one time dose intradiscally.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
16.7%
1/6 • 24 month
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
|
General disorders
Injection site pain
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
33.3%
2/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Infections and infestations
Bronchitis
|
33.3%
2/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Infections and infestations
Ear infection
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Infections and infestations
Gastroenteritis viral
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Infections and infestations
Influenza
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Infections and infestations
Otitis media
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
|
Injury, poisoning and procedural complications
Procedural pain
|
33.3%
2/6 • 24 month
|
50.0%
3/6 • 24 month
|
16.7%
1/6 • 24 month
|
50.0%
3/6 • 24 month
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
3/6 • 24 month
|
33.3%
2/6 • 24 month
|
66.7%
4/6 • 24 month
|
16.7%
1/6 • 24 month
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
3/6 • 24 month
|
33.3%
2/6 • 24 month
|
16.7%
1/6 • 24 month
|
16.7%
1/6 • 24 month
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • 24 month
|
33.3%
2/6 • 24 month
|
33.3%
2/6 • 24 month
|
33.3%
2/6 • 24 month
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
66.7%
4/6 • 24 month
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
33.3%
2/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
16.7%
1/6 • 24 month
|
16.7%
1/6 • 24 month
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
16.7%
1/6 • 24 month
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
16.7%
1/6 • 24 month
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Nervous system disorders
Lumbar radiculopathy
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Nervous system disorders
Radicular pain
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Nervous system disorders
Radiculopathy
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Nervous system disorders
Tension headache
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Renal and urinary disorders
Urinary incontinence
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/6 • 24 month
|
16.7%
1/6 • 24 month
|
0.00%
0/6 • 24 month
|
0.00%
0/6 • 24 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60