Trial Outcomes & Findings for Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial (NCT NCT00822926)

Last Updated: 2017-08-15

Results Overview

Participants completed the Pain Numeric Rating Scale everyday after the injections. Outcome measure represents the number of days before pain returned to baseline levels.

Recruitment status

TERMINATED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

Duration of trial (2-20 months, depending on how long pain relief lasts)

Results posted on

2017-08-15

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Then Botox Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue	Botox Then Placebo Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue
First Injection Visit STARTED	2	3
First Injection Visit COMPLETED	2	3
First Injection Visit NOT COMPLETED	0	0
Washout (Varies Based on Scheduling) STARTED	2	3
Washout (Varies Based on Scheduling) COMPLETED	2	3
Washout (Varies Based on Scheduling) NOT COMPLETED	0	0
Second Injection Visit STARTED	2	3
Second Injection Visit COMPLETED	1	2
Second Injection Visit NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Then Botox Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue	Botox Then Placebo Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue
Second Injection Visit Lost to Follow-up	1	0
Second Injection Visit Withdrawal by Subject	0	1

Baseline Characteristics

Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Then Botox n=2 Participants Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue	Botox Then Placebo n=2 Participants Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	49 years STANDARD_DEVIATION 4.24 • n=5 Participants	48.5 years STANDARD_DEVIATION 7.78 • n=7 Participants	48.75 years STANDARD_DEVIATION 5.12 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Duration of trial (2-20 months, depending on how long pain relief lasts)

Population: A total of 3 participants completed the study (1 received Placebo first then Botox, 2 received Botox first then Placebo). Each of those 3 participants received both Placebo and Botox, as represented in the overall number of participants analyzed for both treatments.

Participants completed the Pain Numeric Rating Scale everyday after the injections. Outcome measure represents the number of days before pain returned to baseline levels.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Saline- Subcutaneous injection of saline into scar tissue	Botox n=3 Participants Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue	Botox Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
Time to Analgesic Failure	120.67 days Standard Deviation 166.79	20.67 days Standard Deviation 22.72	—

SECONDARY outcome

Timeframe: Duration of trial (2-20 months, depending on how long pain relief lasts)

The Beck Depression Inventory was used to assess psychosocial function. Scores were measured at baseline, their final questionnaire following the first injection visit, and their final questionnaire following their second injection visit. Scores range from 0-63, with lower scores representing less severe depression symptoms and higher scores representing more severe depression symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Saline- Subcutaneous injection of saline into scar tissue	Botox n=3 Participants Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue	Botox n=3 Participants Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
Improvement in Psychosocial Function as Assessed by Outcomes as Dictated by the IMMPACT Guidelines	12.33 Units on a scale Standard Deviation 3.79	8 Units on a scale Standard Deviation 7.21	8 Units on a scale Standard Deviation 4.36

SECONDARY outcome

Timeframe: 3 weeks after injection

Pain scores were measured at baseline, 3 weeks after placebo, and 3 weeks after botox. Scores range from 0 (no pain) to 10 (severe, disabling pain).

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Saline- Subcutaneous injection of saline into scar tissue	Botox n=3 Participants Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue	Botox n=3 Participants Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
NRS Score Three Weeks After Injection	3.39 Units on a scale Standard Deviation 2.46	0.86 Units on a scale Standard Deviation 0.7	3.2 Units on a scale Standard Deviation 2.18

Adverse Events

Placebo Then Botox

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Botox Then Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo Then Botox n=2 participants at risk Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue	Botox Then Placebo n=3 participants at risk Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue
General disorders Stomach flu	0.00% 0/2	33.3% 1/3 • Number of events 1

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