Trial Outcomes & Findings for Subcutaneous Botulinum Toxin for Cutaneous Allodynia (NCT NCT00725322)
NCT ID: NCT00725322
Last Updated: 2017-10-25
Results Overview
Participants made daily NRS reports via Palm Pilot, and "failure" was defined as (Pre-injection baseline NRS) - (Mean NRS for any 3 preceding days) ≤ 0; or 9 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
Each participant was assessed for up to 224 days per intervention (injection) or until they returned to NRS baseline
Results posted on
2017-10-25
Participant Flow
84 total participants were enrolled. 46 were withdrawn before randomization due to failure at screening or following protocol. A total of 38 participants were randomized. A total of 30 participants remained for the first injection after 8 were withdrawn due to medication, surgery, or patient decision. A total of 27 participants completed the study.
Participant milestones
| Measure |
Placebo Then Botox
Placebo - Saline:
Subcutaneous Saline injection given at site of scar neuroma
Botulinum Toxin A:
Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin.
|
Botox Then Placebo
Botulinum Toxin A:
Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue
Placebo - Saline:
Subcutaneous Saline injection given at site of scar neuroma Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin.
|
|---|---|---|
|
First Injection Visit
STARTED
|
15
|
15
|
|
First Injection Visit
COMPLETED
|
15
|
15
|
|
First Injection Visit
NOT COMPLETED
|
0
|
0
|
|
Washout (28 Days)
STARTED
|
15
|
15
|
|
Washout (28 Days)
COMPLETED
|
13
|
14
|
|
Washout (28 Days)
NOT COMPLETED
|
2
|
1
|
|
Second Injection Visit
STARTED
|
13
|
14
|
|
Second Injection Visit
COMPLETED
|
13
|
14
|
|
Second Injection Visit
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo Then Botox
Placebo - Saline:
Subcutaneous Saline injection given at site of scar neuroma
Botulinum Toxin A:
Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin.
|
Botox Then Placebo
Botulinum Toxin A:
Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue
Placebo - Saline:
Subcutaneous Saline injection given at site of scar neuroma Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin.
|
|---|---|---|
|
Washout (28 Days)
Withdrawal by Subject
|
2
|
0
|
|
Washout (28 Days)
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Subcutaneous Botulinum Toxin for Cutaneous Allodynia
Baseline characteristics by cohort
| Measure |
Placebo Then Botox
n=13 Participants
Placebo - Saline:
Subcutaneous Saline injection given at site of scar neuroma
Botulinum Toxin A:
Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue
|
Botox Then Placebo
n=14 Participants
Botulinum Toxin A:
Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue
Placebo - Saline:
Subcutaneous Saline injection given at site of scar neuroma
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
46.62 Years
STANDARD_DEVIATION 14.87 • n=5 Participants
|
50.14 Years
STANDARD_DEVIATION 12.48 • n=7 Participants
|
48.44 Years
STANDARD_DEVIATION 13.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Each participant was assessed for up to 224 days per intervention (injection) or until they returned to NRS baselineParticipants made daily NRS reports via Palm Pilot, and "failure" was defined as (Pre-injection baseline NRS) - (Mean NRS for any 3 preceding days) ≤ 0; or 9 months
Outcome measures
| Measure |
Placebo
n=27 Participants
Placebo - Saline: Subcutaneous Saline injection given at site of scar neuroma
|
Botox
n=27 Participants
Botulinum Toxin A: Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue
|
|---|---|---|
|
Time Until Analgesic Failure
|
76.3 Days
Standard Deviation 86.82
|
79 Days
Standard Deviation 92.12
|
SECONDARY outcome
Timeframe: Three weeks after injectionPopulation: Although 27 participants completed the study, 3 participants were excluded from analysis of the NRS score because they had missing data.
The NRS scores range from 0-100, where 0 indicated no pain and 100 indicated the worst pain.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo - Saline: Subcutaneous Saline injection given at site of scar neuroma
|
Botox
n=24 Participants
Botulinum Toxin A: Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue
|
|---|---|---|
|
NRS Score Three Weeks After Injection
|
35.5 Units on a scale
Standard Deviation 20.07
|
34.7 Units on a scale
Standard Deviation 23.38
|
Adverse Events
Placebo Then Botox
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Botox Then Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Then Botox
n=13 participants at risk
Placebo - Saline:
Subcutaneous Saline injection given at site of scar neuroma
Botulinum Toxin A:
Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin.
|
Botox Then Placebo
n=14 participants at risk
Placebo - Saline:
Subcutaneous Saline injection given at site of scar neuroma
Botulinum Toxin A:
Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin.
|
|---|---|---|
|
General disorders
Dry mouth
|
23.1%
3/13
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
7.1%
1/14
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
|
General disorders
Dyspepsia
|
15.4%
2/13
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
14.3%
2/14
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
|
General disorders
Injection site pain
|
23.1%
3/13
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
64.3%
9/14
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
|
General disorders
Headache
|
38.5%
5/13
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
28.6%
4/14
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
|
General disorders
Nausea
|
15.4%
2/13
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
7.1%
1/14
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
|
General disorders
Flu symptoms
|
7.7%
1/13
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
21.4%
3/14
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
|
General disorders
Torticollis
|
7.7%
1/13
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
0.00%
0/14
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
|
General disorders
Arthralgia
|
30.8%
4/13
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
35.7%
5/14
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
|
General disorders
Back pain
|
23.1%
3/13
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
35.7%
5/14
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
|
General disorders
Increased cough
|
7.7%
1/13
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
14.3%
2/14
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
|
General disorders
Increased weakness
|
23.1%
3/13
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
21.4%
3/14
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
|
General disorders
Dizziness
|
15.4%
2/13
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
21.4%
3/14
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
|
General disorders
Rhinitis
|
15.4%
2/13
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
14.3%
2/14
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
|
General disorders
Other
|
0.00%
0/13
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
7.1%
1/14
Adverse Events were not collected in a way that allows for separation by intervention, thus Adverse Events are reported based on the participant's initial group randomization.
|
Additional Information
Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab
Stanford University School of Medicine
Phone: (650) 498-6477
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place