Trial Outcomes & Findings for BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity (NCT NCT01575054)
NCT ID: NCT01575054
Last Updated: 2016-09-28
Results Overview
The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the ankle flexors by passively moving the ankle plantar flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. The average of the weeks 4 and 6 MAS-B ankle change from baseline is the primary end point. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
468 participants
Primary outcome timeframe
Baseline, 6 Weeks
Results posted on
2016-09-28
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin Type A
Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
|
Normal Saline (Placebo) Followed by Botulinum Toxin Type A
Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
|
|---|---|---|
|
Overall Study
STARTED
|
233
|
235
|
|
Overall Study
COMPLETED
|
204
|
209
|
|
Overall Study
NOT COMPLETED
|
29
|
26
|
Reasons for withdrawal
| Measure |
Botulinum Toxin Type A
Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
|
Normal Saline (Placebo) Followed by Botulinum Toxin Type A
Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
|
|---|---|---|
|
Overall Study
Other Reasons
|
5
|
3
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Personal Reasons
|
10
|
11
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Adverse Event
|
9
|
8
|
Baseline Characteristics
BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity
Baseline characteristics by cohort
| Measure |
Botulinum Toxin Type A
n=233 Participants
Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
|
Normal Saline (Placebo) Followed by Botulinum Toxin Type A
n=235 Participants
Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
|
Total
n=468 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.0 Years
STANDARD_DEVIATION 12.60 • n=5 Participants
|
57.0 Years
STANDARD_DEVIATION 11.88 • n=7 Participants
|
56.5 Years
STANDARD_DEVIATION 12.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
148 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 WeeksPopulation: Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received
The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the ankle flexors by passively moving the ankle plantar flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. The average of the weeks 4 and 6 MAS-B ankle change from baseline is the primary end point. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=233 Participants
Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
|
Normal Saline (Placebo) Followed by Botulinum Toxin Type A
n=235 Participants
Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
|
|---|---|---|
|
Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale
Baseline
|
4.1 Scores on a Scale
Standard Deviation 0.27
|
4.1 Scores on a Scale
Standard Deviation 0.25
|
|
Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale
Change from Baseline at 6 weeks
|
-0.81 Scores on a Scale
Standard Deviation 0.874
|
-0.61 Scores on a Scale
Standard Deviation 0.835
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received
The CGI is a 9-point scale evaluating change from baseline status by the Physician. Scores range from +4 (very marked improvement) to -4 (very marked worsening). The average of the weeks 4 and 6 CGI by Physician score is used as a secondary end point. Higher scores indicate a greater improvement from baseline.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=233 Participants
Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
|
Normal Saline (Placebo) Followed by Botulinum Toxin Type A
n=235 Participants
Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
|
|---|---|---|
|
Clinical Global Impression (CGI) of Overall Change by Physician Using a 9-Point Scale
|
0.86 Scores on a Scale
Standard Deviation 0.953
|
0.65 Scores on a Scale
Standard Deviation 0.902
|
SECONDARY outcome
Timeframe: Week 8Population: Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received
The physician-assessed GAS is an individualized, goal-oriented 6-point scale used to track functional improvement toward active and passive goals. GAS scoring ranged from -3 to 2 (-3 = worse than start; 0 = expected goal/attained the defined therapeutic goal; 2 = much more than expected/improvements clearly exceeded the defined therapeutic goal). Active and Passive Goal scores are presented.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=233 Participants
Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
|
Normal Saline (Placebo) Followed by Botulinum Toxin Type A
n=235 Participants
Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
|
|---|---|---|
|
Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS)
Active Goals (N=226, 228)
|
-0.8 Scores on a Scale
Standard Deviation 1.34 • Interval -0.99 to -0.56
|
-1.0 Scores on a Scale
Standard Deviation 1.33 • Interval -1.19 to -0.76
|
|
Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS)
Passive Goals--use (N=214, 217)
|
-0.5 Scores on a Scale
Standard Deviation 1.42 • Interval -0.77 to -0.31
|
-0.8 Scores on a Scale
Standard Deviation 1.33 • Interval -1.01 to -0.57
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received
The patient is asked to select a number that best describes his/her pain while walking on an 11-point scale from 0 = "no pain" to 10 = "pain as bad as can be imagined". Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score \>0 are included in the analyses.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=180 Participants
Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
|
Normal Saline (Placebo) Followed by Botulinum Toxin Type A
n=164 Participants
Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
|
|---|---|---|
|
Change From Baseline in Average Pain Score While Walking on the 11-Point Pain Scale
Baseline
|
4.5 Scores on a Scale
Standard Deviation 1.95
|
4.5 Scores on a Scale
Standard Deviation 2.13
|
|
Change From Baseline in Average Pain Score While Walking on the 11-Point Pain Scale
Change from Baseline at Week 6 (N=175, 158)
|
-0.8 Scores on a Scale
Standard Deviation 2.30
|
-1.1 Scores on a Scale
Standard Deviation 2.38
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received
The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the optional muscles by passively moving the muscles through their range of motion. Optional muscles treated include: Rectus Femoris, Flexor Digitorum Longus, Flexor Hallucis Longus, and Extensor Hallucis. The scores range from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=143 Participants
Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
|
Normal Saline (Placebo) Followed by Botulinum Toxin Type A
n=133 Participants
Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
|
|---|---|---|
|
Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale
Baseline Rectus Femoris (N=25, 25)
|
3.3 Scores on a Scale
Standard Deviation 0.58
|
3.2 Scores on a Scale
Standard Deviation 0.59
|
|
Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale
Chng from BL at Wk6 in Rectus Femoris (N=24,25)
|
-0.9 Scores on a Scale
Standard Deviation 0.87
|
-1.0 Scores on a Scale
Standard Deviation 1.14
|
|
Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale
Baseline Flexor Digitorum Longus (N=86,88)
|
3.3 Scores on a Scale
Standard Deviation 0.76
|
3.4 Scores on a Scale
Standard Deviation 0.70
|
|
Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale
Chng from BL at Wk6 in Digitorum Longus (N=85,84)
|
-0.9 Scores on a Scale
Standard Deviation 1.11
|
-0.8 Scores on a Scale
Standard Deviation 1.22
|
|
Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale
Baseline Flexor Hallucis Longus (N=73,67)
|
3.1 Scores on a Scale
Standard Deviation 0.81
|
3.2 Scores on a Scale
Standard Deviation 0.83
|
|
Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale
Chng frm BL at Wk6 Flexor Hallucis Longus(N=72,66)
|
-1.0 Scores on a Scale
Standard Deviation 1.30
|
-0.6 Scores on a Scale
Standard Deviation 1.20
|
|
Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale
Baseline Extensor Hallucis (N=23,13)
|
3.6 Scores on a Scale
Standard Deviation 0.49
|
3.6 Scores on a Scale
Standard Deviation 0.51
|
|
Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale
Chng from BL at Wk6 in Extensor Hallucis (N=23,13)
|
-1.3 Scores on a Scale
Standard Deviation 1.22
|
-1.3 Scores on a Scale
Standard Deviation 1.09
|
Adverse Events
Botulinum Toxin Type A
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Saline (Placebo)
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Botulinum Toxin Type A
n=231 participants at risk
Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles.
|
Normal Saline (Placebo)
n=233 participants at risk
Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles.
|
|---|---|---|
|
Cardiac disorders
Bifascicular block
|
0.00%
0/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.43%
1/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.43%
1/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.43%
1/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.43%
1/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.43%
1/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.43%
1/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.43%
1/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.00%
0/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.43%
1/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.00%
0/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Chronic sinusitis
|
0.43%
1/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.00%
0/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Pilonidal cyst
|
0.43%
1/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.00%
0/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.43%
1/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.00%
0/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.43%
1/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.00%
0/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.43%
1/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.00%
0/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
0.43%
1/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.00%
0/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
0.43%
1/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.00%
0/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Investigations
Barbiturates positive
|
0.43%
1/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.00%
0/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Investigations
Opiates positive
|
0.43%
1/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.00%
0/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.43%
1/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.43%
1/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.43%
1/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.00%
0/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.43%
1/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.43%
1/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Psychiatric disorders
Depression
|
0.87%
2/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.00%
0/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Psychiatric disorders
Drug abuse
|
0.43%
1/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.00%
0/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.43%
1/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.00%
0/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bullous lung disease
|
0.00%
0/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.43%
1/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haemorrhage
|
0.00%
0/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.43%
1/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.43%
1/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.00%
0/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.43%
1/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.43%
1/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/231
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
0.43%
1/233
The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
|
Other adverse events
Adverse event data not reported
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