Trial Outcomes & Findings for Injecting Botulinum Toxin A Underneath the Skin to Treat Spinal Cord Pain in Patients With Spinal Cord Injury (NCT NCT02736890)
NCT ID: NCT02736890
Last Updated: 2019-04-09
Results Overview
Participant rated pain intensity from 0-10, with higher score indicating more pain
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
up to 12 weeks post-injection, for a total of 24 weeks from baseline
Results posted on
2019-04-09
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin A Then Placebo
Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks, then Placebo 0.2mL of 0.9% normal saline for 12 weeks.
|
Placebo Then Botulinum Toxin A
Placebo 0.2mL of 0.9% normal saline for 12 weeks, then Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks.
|
|---|---|---|
|
First 12 Weeks
STARTED
|
5
|
3
|
|
First 12 Weeks
COMPLETED
|
5
|
3
|
|
First 12 Weeks
NOT COMPLETED
|
0
|
0
|
|
Crossover Next 12 Weeks
STARTED
|
5
|
3
|
|
Crossover Next 12 Weeks
COMPLETED
|
3
|
1
|
|
Crossover Next 12 Weeks
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Botulinum Toxin A Then Placebo
Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks, then Placebo 0.2mL of 0.9% normal saline for 12 weeks.
|
Placebo Then Botulinum Toxin A
Placebo 0.2mL of 0.9% normal saline for 12 weeks, then Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks.
|
|---|---|---|
|
Crossover Next 12 Weeks
Lost to Follow-up
|
1
|
2
|
|
Crossover Next 12 Weeks
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Injecting Botulinum Toxin A Underneath the Skin to Treat Spinal Cord Pain in Patients With Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Botulinum Toxin A Then Placebo
n=5 Participants
Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks, then Placebo 0.2mL of 0.9% normal saline for 12 weeks.
|
Placebo Then Botulinum Toxin A
n=3 Participants
Placebo 0.2mL of 0.9% normal saline for 12 weeks, then Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.6 years
STANDARD_DEVIATION 7.02 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 4.04 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 9.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
DN4 screen (neuropathic >4)
Burning
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
DN4 screen (neuropathic >4)
Painful cold
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
DN4 screen (neuropathic >4)
Electric shock
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
DN4 screen (neuropathic >4)
Tingling
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
DN4 screen (neuropathic >4)
Pins and needles
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
DN4 screen (neuropathic >4)
Numbness
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
DN4 screen (neuropathic >4)
Itching
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
DN4 screen (neuropathic >4)
Hypoesthesia to touch
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
DN4 screen (neuropathic >4)
Hypoesthesia to prick
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
DN4 screen (neuropathic >4)
Brushing
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
SCIPI screen (neuropathic >=3)
Electric shock
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
SCIPI screen (neuropathic >=3)
Pins and needles
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
SCIPI screen (neuropathic >=3)
Burning or freezing
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
SCIPI screen (neuropathic >=3)
Sensitive
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
SCIPI screen (neuropathic >=3)
Unchanged with movement
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
SCIPI screen (neuropathic >=3)
All the time when awake
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
SCIPI screen (neuropathic >=3)
No feeling in area
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeks post-injection, for a total of 24 weeks from baselinePopulation: only those who completed crossover were included
Participant rated pain intensity from 0-10, with higher score indicating more pain
Outcome measures
| Measure |
Botulinum Toxin A Then Placebo
n=5 Participants
Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks, then Placebo 0.2mL of 0.9% normal saline for 12 weeks.
|
Placebo Then Botulinum Toxin A
n=3 Participants
Placebo 0.2mL of 0.9% normal saline for 12 weeks, then Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks.
|
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
baseline
|
7.6 score on a scale
Standard Deviation 1.5
|
8 score on a scale
Standard Deviation 0
|
|
Numeric Pain Rating Scale (NPRS)
2 week post injection
|
6.4 score on a scale
Standard Deviation 0.9
|
8 score on a scale
Standard Deviation 0
|
|
Numeric Pain Rating Scale (NPRS)
4 week post injection
|
5.6 score on a scale
Standard Deviation 1.7
|
8 score on a scale
Standard Deviation 0
|
|
Numeric Pain Rating Scale (NPRS)
8 week post injection
|
5.6 score on a scale
Standard Deviation 2.6
|
8 score on a scale
Standard Deviation 0
|
|
Numeric Pain Rating Scale (NPRS)
12 week post injection
|
5.6 score on a scale
Standard Deviation 3.3
|
8 score on a scale
Standard Deviation 0
|
|
Numeric Pain Rating Scale (NPRS)
crossover 2 week follow up
|
8 score on a scale
Standard Deviation 0
|
5 score on a scale
Standard Deviation 0
|
|
Numeric Pain Rating Scale (NPRS)
crossover 4 week follow up
|
8 score on a scale
Standard Deviation 0
|
5 score on a scale
Standard Deviation 0
|
|
Numeric Pain Rating Scale (NPRS)
crossover 8 week follow up
|
6.7 score on a scale
Standard Deviation 1.5
|
6 score on a scale
Standard Deviation 0
|
|
Numeric Pain Rating Scale (NPRS)
crossover 12 week follow up
|
8 score on a scale
Standard Deviation 1
|
7 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: up to 12 weeks post-injection, for a total of 24 weeks from baselinePopulation: only those who completed crossover were included
Mean change from baseline. Participants are asked "Taking into account your pain level and how it affects your life, are you feeling better, the same or worse than when you started treatment?" and then to quantify the magnitude of the change. with the 7-Point guy Farrar which measures the global treatment effect from with scale from 0 to 6, higher score indicates worse outcomes.
Outcome measures
| Measure |
Botulinum Toxin A Then Placebo
n=5 Participants
Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks, then Placebo 0.2mL of 0.9% normal saline for 12 weeks.
|
Placebo Then Botulinum Toxin A
n=3 Participants
Placebo 0.2mL of 0.9% normal saline for 12 weeks, then Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks.
|
|---|---|---|
|
7-Point Guy/Farrar Patient Global Impression of Change (PGIC)
2 week post injection
|
2.2 score on a scale
Standard Deviation 2.2
|
0.3 score on a scale
Standard Deviation 0.6
|
|
7-Point Guy/Farrar Patient Global Impression of Change (PGIC)
4 week post injection
|
2.4 score on a scale
Standard Deviation 1.5
|
0.3 score on a scale
Standard Deviation 0.6
|
|
7-Point Guy/Farrar Patient Global Impression of Change (PGIC)
8 week post injection
|
2 score on a scale
Standard Deviation 1.6
|
0 score on a scale
Standard Deviation 0
|
|
7-Point Guy/Farrar Patient Global Impression of Change (PGIC)
12 week post injection
|
2 score on a scale
Standard Deviation 1.9
|
0 score on a scale
Standard Deviation 0
|
|
7-Point Guy/Farrar Patient Global Impression of Change (PGIC)
crossover 2 week follow up
|
0 score on a scale
Standard Deviation 0
|
5 score on a scale
Standard Deviation 0
|
|
7-Point Guy/Farrar Patient Global Impression of Change (PGIC)
crossover 4 week follow up
|
0 score on a scale
Standard Deviation 0
|
5 score on a scale
Standard Deviation 0
|
|
7-Point Guy/Farrar Patient Global Impression of Change (PGIC)
crossover 8 week follow up
|
0 score on a scale
Standard Deviation 0
|
3 score on a scale
Standard Deviation 0
|
|
7-Point Guy/Farrar Patient Global Impression of Change (PGIC)
crossover 12 week follow up
|
0 score on a scale
Standard Deviation 0
|
1 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: up to 12 weeks post-injection, for a total of 24 weeks from baselinePopulation: only those who completed crossover were included
The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting day-to-day activities subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes.
Outcome measures
| Measure |
Botulinum Toxin A Then Placebo
n=5 Participants
Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks, then Placebo 0.2mL of 0.9% normal saline for 12 weeks.
|
Placebo Then Botulinum Toxin A
n=3 Participants
Placebo 0.2mL of 0.9% normal saline for 12 weeks, then Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks.
|
|---|---|---|
|
International Basic Pain Dataset - Pain Affecting Day-to-day Activities
8 week post injection
|
5 units on a scale
Standard Deviation 1.6
|
2.7 units on a scale
Standard Deviation 4.6
|
|
International Basic Pain Dataset - Pain Affecting Day-to-day Activities
12 week post injection
|
4.8 units on a scale
Standard Deviation 2.0
|
2.7 units on a scale
Standard Deviation 4.6
|
|
International Basic Pain Dataset - Pain Affecting Day-to-day Activities
Baseline
|
4.2 units on a scale
Standard Deviation 4.1
|
5.3 units on a scale
Standard Deviation 4.6
|
|
International Basic Pain Dataset - Pain Affecting Day-to-day Activities
2 week post injection
|
5.4 units on a scale
Standard Deviation 1.5
|
2.7 units on a scale
Standard Deviation 4.6
|
|
International Basic Pain Dataset - Pain Affecting Day-to-day Activities
4 week post injection
|
5 units on a scale
Standard Deviation 1.2
|
2.7 units on a scale
Standard Deviation 4.6
|
|
International Basic Pain Dataset - Pain Affecting Day-to-day Activities
crossover 2 week follow up
|
7 units on a scale
Standard Deviation 1.7
|
2 units on a scale
Standard Deviation 0
|
|
International Basic Pain Dataset - Pain Affecting Day-to-day Activities
crossover 4 week follow up
|
6.7 units on a scale
Standard Deviation 2.3
|
3 units on a scale
Standard Deviation 0
|
|
International Basic Pain Dataset - Pain Affecting Day-to-day Activities
crossover 8 week follow up
|
7 units on a scale
Standard Deviation 2.6
|
4 units on a scale
Standard Deviation 0
|
|
International Basic Pain Dataset - Pain Affecting Day-to-day Activities
crossover 12 week follow up
|
6.7 units on a scale
Standard Deviation 3.2
|
5 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: up to 12 weeks post-injection, for a total of 24 weeks from baselinePopulation: only those who completed crossover were included
The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting mood subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes.
Outcome measures
| Measure |
Botulinum Toxin A Then Placebo
n=5 Participants
Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks, then Placebo 0.2mL of 0.9% normal saline for 12 weeks.
|
Placebo Then Botulinum Toxin A
n=3 Participants
Placebo 0.2mL of 0.9% normal saline for 12 weeks, then Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks.
|
|---|---|---|
|
International Basic Pain Dataset - Pain Affecting Mood
Baseline
|
5.6 units on a scale
Standard Deviation 3.5
|
5.7 units on a scale
Standard Deviation 4.9
|
|
International Basic Pain Dataset - Pain Affecting Mood
2 week post injection
|
6.6 units on a scale
Standard Deviation 2.3
|
2.7 units on a scale
Standard Deviation 4.6
|
|
International Basic Pain Dataset - Pain Affecting Mood
4 week post injection
|
5.8 units on a scale
Standard Deviation 1.5
|
2.7 units on a scale
Standard Deviation 4.6
|
|
International Basic Pain Dataset - Pain Affecting Mood
8 week post injection
|
5.2 units on a scale
Standard Deviation 0.8
|
4.3 units on a scale
Standard Deviation 4.5
|
|
International Basic Pain Dataset - Pain Affecting Mood
12 week post injection
|
5.6 units on a scale
Standard Deviation 1.8
|
5.7 units on a scale
Standard Deviation 4.9
|
|
International Basic Pain Dataset - Pain Affecting Mood
crossover 2 week follow up
|
7 units on a scale
Standard Deviation 1.7
|
2 units on a scale
Standard Deviation 0
|
|
International Basic Pain Dataset - Pain Affecting Mood
crossover 4 week follow up
|
7 units on a scale
Standard Deviation 1.7
|
3 units on a scale
Standard Deviation 0
|
|
International Basic Pain Dataset - Pain Affecting Mood
crossover 8 week follow up
|
7.3 units on a scale
Standard Deviation 2.1
|
4 units on a scale
Standard Deviation 0
|
|
International Basic Pain Dataset - Pain Affecting Mood
crossover 12 week follow up
|
6.7 units on a scale
Standard Deviation 3.2
|
7 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: up to 12 weeks post-injection, for a total of 24 weeks from baselinePopulation: only those who completed crossover were included
The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting sleep subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes.
Outcome measures
| Measure |
Botulinum Toxin A Then Placebo
n=5 Participants
Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks, then Placebo 0.2mL of 0.9% normal saline for 12 weeks.
|
Placebo Then Botulinum Toxin A
n=3 Participants
Placebo 0.2mL of 0.9% normal saline for 12 weeks, then Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks.
|
|---|---|---|
|
International Basic Pain Dataset - Pain Affecting Sleep
2 week post injection
|
4.6 units on a scale
Standard Deviation 3.6
|
4.7 units on a scale
Standard Deviation 3.1
|
|
International Basic Pain Dataset - Pain Affecting Sleep
crossover 12 week follow up
|
7.3 units on a scale
Standard Deviation 2.1
|
5 units on a scale
Standard Deviation 0
|
|
International Basic Pain Dataset - Pain Affecting Sleep
Baseline
|
5.8 units on a scale
Standard Deviation 3.8
|
6.7 units on a scale
Standard Deviation 2.3
|
|
International Basic Pain Dataset - Pain Affecting Sleep
4 week post injection
|
5 units on a scale
Standard Deviation 2.3
|
3.3 units on a scale
Standard Deviation 4.2
|
|
International Basic Pain Dataset - Pain Affecting Sleep
8 week post injection
|
6 units on a scale
Standard Deviation 1.6
|
6 units on a scale
Standard Deviation 2.0
|
|
International Basic Pain Dataset - Pain Affecting Sleep
12 week post injection
|
6.2 units on a scale
Standard Deviation 2.2
|
6.7 units on a scale
Standard Deviation 2.3
|
|
International Basic Pain Dataset - Pain Affecting Sleep
crossover 2 week follow up
|
8 units on a scale
Standard Deviation 0
|
1 units on a scale
Standard Deviation 0
|
|
International Basic Pain Dataset - Pain Affecting Sleep
crossover 4 week follow up
|
8 units on a scale
Standard Deviation 0
|
3 units on a scale
Standard Deviation 0
|
|
International Basic Pain Dataset - Pain Affecting Sleep
crossover 8 week follow up
|
8 units on a scale
Standard Deviation 0
|
4 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: up to 12 weeks post-injection, for a total of 24 weeks from baselinePopulation: Data initially collected incorrectly, then data not collected.
Mechanical allodynia is a characteristic of evoked pain in subjects with neuropathic pain. Static allodynia to mechanical stimuli will be defined as a sensation of pain evoked by the pressure of the end of a wooden stick. The end of a wooden stick will touch the affected region with enough pressure to indent the skin, for 10 seconds. Afterwards, the subject will be asked to rate the perceived pain on an 11-point NRS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 12 weeks post-injection, for a total of 24 weeks from baselinePopulation: Data initially collected incorrectly, then data not collected.
Dynamic allodynia will be tested by stroking the affected region gently with a cotton swab, 4 times at a rate of 3-5cm per second over an area of 5cm. If there is an evoked clear sensation of pain, the subject is asked to rate the intensity of dynamic allodynia using the 11-point NRS. The region of static and dynamic allodynia, if present, will be marked and recorded
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 12 weeks post-injection, for a total of 24 weeks from baselinePopulation: only those who completed crossover were included
PGI measures activity affected by pain. Full score is 0 to 10000, with higher score indicating better function
Outcome measures
| Measure |
Botulinum Toxin A Then Placebo
n=5 Participants
Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks, then Placebo 0.2mL of 0.9% normal saline for 12 weeks.
|
Placebo Then Botulinum Toxin A
n=3 Participants
Placebo 0.2mL of 0.9% normal saline for 12 weeks, then Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks.
|
|---|---|---|
|
Patient-generated Index (PGI)
Baseline
|
4250 score on a scale
Standard Deviation 1885.5
|
1500 score on a scale
Standard Deviation 1802.8
|
|
Patient-generated Index (PGI)
2 week post injection
|
5240 score on a scale
Standard Deviation 1892.9
|
1550 score on a scale
Standard Deviation 1789.6
|
|
Patient-generated Index (PGI)
4 week post injection
|
5219 score on a scale
Standard Deviation 2130.8
|
1825 score on a scale
Standard Deviation 2439.5
|
|
Patient-generated Index (PGI)
8 week post injection
|
3725 score on a scale
Standard Deviation 1492.5
|
2800 score on a scale
Standard Deviation 2498.0
|
|
Patient-generated Index (PGI)
12 week post injection
|
4330 score on a scale
Standard Deviation 2038.9
|
1800 score on a scale
Standard Deviation 2545.6
|
|
Patient-generated Index (PGI)
crossover 2 week follow up
|
3333.3 score on a scale
Standard Deviation 763.8
|
3500 score on a scale
Standard Deviation 0
|
|
Patient-generated Index (PGI)
crossover 4 week follow up
|
3333.3 score on a scale
Standard Deviation 763.8
|
3750 score on a scale
Standard Deviation 0
|
|
Patient-generated Index (PGI)
crossover 8 week follow up
|
3333.3 score on a scale
Standard Deviation 763.8
|
3000 score on a scale
Standard Deviation 0
|
|
Patient-generated Index (PGI)
crossover 12 week follow up
|
3333.3 score on a scale
Standard Deviation 763.8
|
1500 score on a scale
Standard Deviation 0
|
Adverse Events
Botulinum Toxin A
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Botulinum Toxin A
n=8 participants at risk
Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks
|
Placebo
n=8 participants at risk
Placebo 0.2mL of 0.9% normal saline for 12 weeks
|
|---|---|---|
|
Vascular disorders
thrombosed IVCF
|
12.5%
1/8 • 24 weeks post injection
|
0.00%
0/8 • 24 weeks post injection
|
Other adverse events
| Measure |
Botulinum Toxin A
n=8 participants at risk
Injection 0.2mL (BOTOX, 5 units), with maximum of 80 injections, 400 Units for 12 weeks
|
Placebo
n=8 participants at risk
Placebo 0.2mL of 0.9% normal saline for 12 weeks
|
|---|---|---|
|
Infections and infestations
fever
|
12.5%
1/8 • 24 weeks post injection
|
0.00%
0/8 • 24 weeks post injection
|
Additional Information
Dr. Thomas Bryce
Icahn School of Medicine at Mount Sinai
Phone: 212-241-6321
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Recipient will have all rights to data resulting from the Study; provided, however, at least 30 calendar days prior to any submission...Recipient shall provide Allergan a copy of the proposed publication for review. Recipient agrees to delay submission for an additional 30 calendar days to allow Allergan the right to a) address any factual inaccuracies with the publisher as it relates to any Allergan materials or b) request redaction of information that Allergan deems confidential or proprietary
- Publication restrictions are in place
Restriction type: OTHER