Trial Outcomes & Findings for A Two-Part Study of BOTOX® Therapy for Ischemic Digits (NCT NCT01309802)
NCT ID: NCT01309802
Last Updated: 2019-01-08
Results Overview
Subjective pain scales \[visual analogue scale (VAS) and faces pain assessment\]. Subjects reporting total number of pain free days within the time period of 0-28 days.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
baseline to 28 days
Results posted on
2019-01-08
Participant Flow
Participant milestones
| Measure |
Placebo
no intervention
|
Onabotulinum Toxin Type-A
up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
23
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
12
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=25 Participants
no intervention
|
Onabotulinum Toxin Type-A
n=23 Participants
up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=48 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=25 Participants
|
19 Participants
n=23 Participants
|
42 Participants
n=48 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=25 Participants
|
4 Participants
n=23 Participants
|
6 Participants
n=48 Participants
|
|
Age, Continuous
|
53.3 years
n=25 Participants
|
49.2 years
n=23 Participants
|
51.3 years
n=48 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=25 Participants
|
19 Participants
n=23 Participants
|
40 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=25 Participants
|
4 Participants
n=23 Participants
|
8 Participants
n=48 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
23 participants
n=23 Participants
|
48 participants
n=48 Participants
|
PRIMARY outcome
Timeframe: baseline to 28 daysSubjective pain scales \[visual analogue scale (VAS) and faces pain assessment\]. Subjects reporting total number of pain free days within the time period of 0-28 days.
Outcome measures
| Measure |
Placebo
n=25 Participants
no intervention
|
Onabotulinum Toxin Type-A
n=23 Participants
up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
|
|---|---|---|
|
Percentage of Patient Reported Pain-free Days
|
12 percentage of pain free days
|
48 percentage of pain free days
|
SECONDARY outcome
Timeframe: change from baseline to 28 daysPopulation: Data were not collected,
SF-12v2® Health Survey - Pain Enhanced
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 28 daysPopulation: Data were not collected
Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) Outcome Measure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 28 daysThe Optum SF-12v2® Health Survey - A Short Patient Reported Survey Measuring Health Using Excellent, Very Good, Good, Fair and Poor Indicators. On a scale from Excellent to Poor, Excellent being the maximum outcome. Good is scored as average. Patient satisfaction assessed as the percentage of participants who responded; Excellent, Very Good and Good on the health survey on average feeling between baseline and 28 days.
Outcome measures
| Measure |
Placebo
n=25 Participants
no intervention
|
Onabotulinum Toxin Type-A
n=23 Participants
up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
|
|---|---|---|
|
Patient Satisfaction
|
12 percentage of participants
|
48 percentage of participants
|
SECONDARY outcome
Timeframe: baseline to 28 daysPopulation: Data were not collected
Doppler perfusion imager and Periscan image analysis software
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 28 daysPopulation: not were not collected
A combined reported score measuring 5 dimensions; mobility, self care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels; no problems, some problems, extreme problems
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Onabotulinum Toxin Type-A
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=25 participants at risk
no intervention
|
Onabotulinum Toxin Type-A
n=23 participants at risk
up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
|
|---|---|---|
|
Injury, poisoning and procedural complications
Broken bone
|
4.0%
1/25 • Number of events 1 • For adverse events were followed to resolution.
|
0.00%
0/23 • For adverse events were followed to resolution.
|
|
Infections and infestations
Infection
|
8.0%
2/25 • Number of events 2 • For adverse events were followed to resolution.
|
4.3%
1/23 • Number of events 1 • For adverse events were followed to resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Collapsed Lung
|
0.00%
0/25 • For adverse events were followed to resolution.
|
4.3%
1/23 • Number of events 1 • For adverse events were followed to resolution.
|
|
Injury, poisoning and procedural complications
Dizziness
|
4.0%
1/25 • Number of events 1 • For adverse events were followed to resolution.
|
0.00%
0/23 • For adverse events were followed to resolution.
|
|
General disorders
Throat Swelling
|
4.0%
1/25 • Number of events 3 • For adverse events were followed to resolution.
|
0.00%
0/23 • For adverse events were followed to resolution.
|
Other adverse events
| Measure |
Placebo
n=25 participants at risk
no intervention
|
Onabotulinum Toxin Type-A
n=23 participants at risk
up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
|
|---|---|---|
|
General disorders
Pain, Redness, Bleeding
|
56.0%
14/25 • Number of events 35 • For adverse events were followed to resolution.
|
60.9%
14/23 • Number of events 31 • For adverse events were followed to resolution.
|
|
General disorders
Swelling, Tenderness, Bruising
|
48.0%
12/25 • Number of events 17 • For adverse events were followed to resolution.
|
30.4%
7/23 • Number of events 9 • For adverse events were followed to resolution.
|
|
Musculoskeletal and connective tissue disorders
Temporary Weakness or numbness of muscle
|
64.0%
16/25 • Number of events 32 • For adverse events were followed to resolution.
|
47.8%
11/23 • Number of events 20 • For adverse events were followed to resolution.
|
|
General disorders
Dizziness, Drowsiness
|
12.0%
3/25 • Number of events 3 • For adverse events were followed to resolution.
|
13.0%
3/23 • Number of events 4 • For adverse events were followed to resolution.
|
|
General disorders
Dry Eyes, Dry Mouth
|
4.0%
1/25 • Number of events 2 • For adverse events were followed to resolution.
|
0.00%
0/23 • For adverse events were followed to resolution.
|
|
Eye disorders
Vision Changes
|
0.00%
0/25 • For adverse events were followed to resolution.
|
4.3%
1/23 • Number of events 1 • For adverse events were followed to resolution.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • Number of events 1 • For adverse events were followed to resolution.
|
4.3%
1/23 • Number of events 1 • For adverse events were followed to resolution.
|
|
General disorders
Increased Cough, Runny nose
|
4.0%
1/25 • Number of events 2 • For adverse events were followed to resolution.
|
0.00%
0/23 • For adverse events were followed to resolution.
|
|
General disorders
Allergic Reaction or Itching
|
8.0%
2/25 • Number of events 2 • For adverse events were followed to resolution.
|
0.00%
0/23 • For adverse events were followed to resolution.
|
|
General disorders
Tingling
|
0.00%
0/25 • For adverse events were followed to resolution.
|
4.3%
1/23 • Number of events 1 • For adverse events were followed to resolution.
|
|
General disorders
Shortness of breath
|
4.0%
1/25 • Number of events 1 • For adverse events were followed to resolution.
|
8.7%
2/23 • Number of events 2 • For adverse events were followed to resolution.
|
|
General disorders
Difficulty Swallowing
|
8.0%
2/25 • Number of events 2 • For adverse events were followed to resolution.
|
0.00%
0/23 • For adverse events were followed to resolution.
|
Additional Information
Research Administrator
Southern Illinois University School of Medicine
Phone: 217-545-2531
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place