Trial Outcomes & Findings for Botulinum Toxin in Raynaud's Phenomenon (NCT NCT05125029)
NCT ID: NCT05125029
Last Updated: 2026-07-29
Results Overview
Finger temperature measure of each finger on each hand was recorded on each digit before treatment and at the allotted follow-up intervals; the average of all digits on both hands was combined and recorded as the value for each point in data collection.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
Baseline, 4 weeks, 12 weeks, 24 weeks post injection
Results posted on
2026-07-29
Participant Flow
A total of 24 participants were recruited from Emory University Hospital. Participant enrollment began February 10, 2022, and all follow-up assessments were completed by May 15, 2025
Participant milestones
| Measure |
10 Units of BT Per Digit
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
20 Units of BT Per Digit
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
Placebo
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations such that the investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
10 Units of BT Per Digit
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
20 Units of BT Per Digit
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
Placebo
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations such that the investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Botulinum Toxin in Raynaud's Phenomenon
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations such that the investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
|
10 Units of BT Per Digit
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
20 Units of BT Per Digit
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
21 Participants
n=265 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
20 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
19 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
9 Participants
n=265 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
11 Participants
n=265 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 12 weeks, 24 weeks post injectionPopulation: Only 7 participants in each arm (20 units and placebo) completed all scheduled visits. Missed follow-ups: * Placebo arm: 3 different participants each missed one follow-up visit \-- 4-week visit (1), 12-wk visit (1), 24-week visit (1) * 20-unit arm: 1 participant had incomplete follow-up-lost to follow-up after 4-week visit (1)
Finger temperature measure of each finger on each hand was recorded on each digit before treatment and at the allotted follow-up intervals; the average of all digits on both hands was combined and recorded as the value for each point in data collection.
Outcome measures
| Measure |
10 Units of BT Per Digit
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
20 Units of BT Per Digit
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
Placebo
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations such that the investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
|
|---|---|---|---|
|
Finger Temperature Measure
Week 24
|
26.55 degrees Celsius
Standard Deviation 0.79
|
24.41 degrees Celsius
Standard Deviation 0.84
|
25.10 degrees Celsius
Standard Deviation 0.83
|
|
Finger Temperature Measure
Baseline
|
26.91 degrees Celsius
Standard Deviation 2.74
|
25.62 degrees Celsius
Standard Deviation 1.42
|
26.57 degrees Celsius
Standard Deviation 3.23
|
|
Finger Temperature Measure
Week 4
|
25.96 degrees Celsius
Standard Deviation 0.79
|
27.80 degrees Celsius
Standard Deviation 0.84
|
25.97 degrees Celsius
Standard Deviation 0.83
|
|
Finger Temperature Measure
Week 12
|
26.07 degrees Celsius
Standard Deviation 0.87
|
28.33 degrees Celsius
Standard Deviation 0.95
|
25.97 degrees Celsius
Standard Deviation 0.93
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 12 weeks, 24 weeks post injectionPopulation: Only 7 participants in each arm (20 units and placebo) completed all scheduled visits. Missed follow-ups: Placebo arm: 3 different participants each missed one follow-up visit \-- 4-week visit (1), 12-wk visit (1), 24-week visit (1) 20-unit arm: 1 participant had incomplete follow-up-lost to follow-up after 4-week visit (1)
Tissue Oximetry of each finger on each hand was recorded on each digit before treatment and at the allotted follow-up intervals. The average of all digits on both hands was combined and reported.
Outcome measures
| Measure |
10 Units of BT Per Digit
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
20 Units of BT Per Digit
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
Placebo
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations such that the investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
|
|---|---|---|---|
|
Tissue Oximetry Measure for Each Finger
Baseline
|
91.21 % of oxygen saturation
Standard Deviation 4.37
|
87.78 % of oxygen saturation
Standard Deviation 11.35
|
92.64 % of oxygen saturation
Standard Deviation 5.87
|
|
Tissue Oximetry Measure for Each Finger
Week 24
|
87.37 % of oxygen saturation
Standard Deviation 4.67
|
85.66 % of oxygen saturation
Standard Deviation 4.80
|
92.59 % of oxygen saturation
Standard Deviation 5.22
|
|
Tissue Oximetry Measure for Each Finger
Week 4
|
84.77 % of oxygen saturation
Standard Deviation 2.27
|
89.48 % of oxygen saturation
Standard Deviation 2.80
|
86.97 % of oxygen saturation
Standard Deviation 2.75
|
|
Tissue Oximetry Measure for Each Finger
Week 12
|
87.64 % of oxygen saturation
Standard Deviation 2.93
|
88.98 % of oxygen saturation
Standard Deviation 2.80
|
94.97 % of oxygen saturation
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: Performed at 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks.Population: Missed follow-ups: Placebo arm: Week 12 (1), 16-wk visit (2), Week 20 (3) 20 unit arm: Week 12 (1), Week 16 (2), Week 20 (3), Week 24 (1) 10 unit arm: Week 16 (3), Week 20 (1)
The Raynaud's Condition Score (RCS) is a validated outcome measure used to assess the level of difficulty experienced due to RP each day (anchored from "no difficulty" to "extreme difficulty"). Scale of 0-10 based on how patients rate any difficulty with their hands the day of assessment, a score of 0 is the minimum score and is interpreted as a best outcome (being described to patients as "no difficulty"), while a score of 10 is the maximum score and is interpreted as the worst outcome (being described to patients as "extreme difficulty")
Outcome measures
| Measure |
10 Units of BT Per Digit
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
20 Units of BT Per Digit
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
Placebo
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations such that the investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
|
|---|---|---|---|
|
Raynaud Condition Score
Week 12
|
4.39 units on a scale
Standard Deviation 1.29
|
4.54 units on a scale
Standard Deviation 1.38
|
3.16 units on a scale
Standard Deviation 1.40
|
|
Raynaud Condition Score
Week 16
|
4.40 units on a scale
Standard Deviation 2.61
|
4.80 units on a scale
Standard Deviation 3.41
|
4.33 units on a scale
Standard Deviation 3.61
|
|
Raynaud Condition Score
Week 20
|
4.43 units on a scale
Standard Deviation 2.07
|
5.00 units on a scale
Standard Deviation 3.08
|
4.40 units on a scale
Standard Deviation 2.70
|
|
Raynaud Condition Score
Week 24
|
4.29 units on a scale
Standard Deviation 0.98
|
4.41 units on a scale
Standard Deviation 1.05
|
3.48 units on a scale
Standard Deviation 0.98
|
|
Raynaud Condition Score
Week 4
|
3.54 units on a scale
Standard Deviation 0.96
|
3.77 units on a scale
Standard Deviation 0.96
|
4.19 units on a scale
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: Performed at 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks.Population: Subjects that are missing from the analysis were unreachable for telephone visits despite multiple attempts.
The visual analogue scale or visual analogue scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints.VAS scores ranged from 0 (no pain) to 10 (worst imaginable pain) Higher VAS scores indicate greater pain severity Week 16 and week 20 measurements were performed via telephone interview.
Outcome measures
| Measure |
10 Units of BT Per Digit
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
20 Units of BT Per Digit
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
Placebo
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations such that the investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
|
|---|---|---|---|
|
Visual Analog Scale (VAS) Pain Score
Week 4
|
2.45 units on a scale
Standard Deviation 0.50
|
2.25 units on a scale
Standard Deviation 0.50
|
3.29 units on a scale
Standard Deviation 0.50
|
|
Visual Analog Scale (VAS) Pain Score
Week 20
|
3.14 units on a scale
Standard Deviation 2.46
|
3.40 units on a scale
Standard Deviation 0.42
|
3.90 units on a scale
Standard Deviation 2.90
|
|
Visual Analog Scale (VAS) Pain Score
Week 24
|
2.36 units on a scale
Standard Deviation 0.59
|
3.40 units on a scale
Standard Deviation 0.63
|
4.10 units on a scale
Standard Deviation 0.59
|
|
Visual Analog Scale (VAS) Pain Score
Week 12
|
2.53 units on a scale
Standard Deviation 0.73
|
2.41 units on a scale
Standard Deviation 0.78
|
2.78 units on a scale
Standard Deviation 0.75
|
|
Visual Analog Scale (VAS) Pain Score
Week 16
|
3.50 units on a scale
Standard Deviation 3.08
|
2.25 units on a scale
Standard Deviation 1.84
|
3.33 units on a scale
Standard Deviation 3.16
|
SECONDARY outcome
Timeframe: 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks.Population: Missed follow-ups: Placebo arm: Week 12 (1), 16-wk visit (2), Week 20 (3) 20 unit arm: Week 12 (1), Week 16 (2), Week 20 (3), Week 24 (1) 10-unit arm: Week 16 (3), Week 20 (1)
The visual analogue scale (VAS) is a psychometric response scale that can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints. Scale of 0-10, a minimum score of 0 is viewed as a favorable outcome and described to patients as having "no pain", a score of 10 is the maximum score and is viewed as an unfavorable outcome and described to patients as having "worst pain"
Outcome measures
| Measure |
10 Units of BT Per Digit
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
20 Units of BT Per Digit
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
Placebo
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations such that the investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
|
|---|---|---|---|
|
PROMIS Pain Interference Scale
Week 16
|
51.56 units on a scale
Standard Deviation 10.64
|
57.85 units on a scale
Standard Deviation 5.24
|
54.70 units on a scale
Standard Deviation 13.80
|
|
PROMIS Pain Interference Scale
Week 20
|
56.16 units on a scale
Standard Deviation 7.69
|
60.62 units on a scale
Standard Deviation 5.18
|
54.96 units on a scale
Standard Deviation 11.54
|
|
PROMIS Pain Interference Scale
Week 4
|
56.06 units on a scale
Standard Deviation 1.69
|
56.72 units on a scale
Standard Deviation 1.67
|
55.09 units on a scale
Standard Deviation 1.70
|
|
PROMIS Pain Interference Scale
Week 12
|
57.13 units on a scale
Standard Deviation 1.80
|
55.77 units on a scale
Standard Deviation 1.90
|
54.26 units on a scale
Standard Deviation 1.90
|
|
PROMIS Pain Interference Scale
Week 24
|
56.15 units on a scale
Standard Deviation 2.01
|
57.84 units on a scale
Standard Deviation 2.11
|
52.22 units on a scale
Standard Deviation 1.99
|
SECONDARY outcome
Timeframe: Performed at 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks.Population: Subjects that are missing from the analysis were unreachable for telephone visits despite multiple attempts. Missed follow-ups: Missed follow-ups: Placebo arm: Week 12 (1), 16-wk visit (2), Week 20 (3) 20-unit arm: Week 12 (1), Week 16 (2), Week 20 (3), Week 24 (1) 10-unit arm: Week 16 (3), Week 20 (1)
Patients provided ratings of their subjective hand function from 0 to 100. Higher ratings mean better outcomes. Week 16 and week 20 measurements were performed via telephone interview.
Outcome measures
| Measure |
10 Units of BT Per Digit
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
20 Units of BT Per Digit
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
Placebo
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations such that the investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
|
|---|---|---|---|
|
Hand Subjectivity Value
Week 20
|
60.71 units on a scale
Standard Deviation 33.72
|
56.00 units on a scale
Standard Deviation 15.17
|
60.00 units on a scale
Standard Deviation 22.08
|
|
Hand Subjectivity Value
Week 24
|
57.21 units on a scale
Standard Deviation 6.50
|
61.90 units on a scale
Standard Deviation 6.69
|
58.00 units on a scale
Standard Deviation 6.45
|
|
Hand Subjectivity Value
Week 16
|
73.40 units on a scale
Standard Deviation 22.20
|
57.17 units on a scale
Standard Deviation 23.63
|
56.67 units on a scale
Standard Deviation 32.04
|
|
Hand Subjectivity Value
Week 4
|
62.92 units on a scale
Standard Deviation 5.11
|
53.57 units on a scale
Standard Deviation 5.95
|
70.39 units on a scale
Standard Deviation 5.12
|
|
Hand Subjectivity Value
Week 12
|
69.03 units on a scale
Standard Deviation 8.18
|
70.85 units on a scale
Standard Deviation 8.33
|
65.97 units on a scale
Standard Deviation 8.77
|
SECONDARY outcome
Timeframe: Performed at 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks.Population: Subjects that are missing from the analysis were unreachable for telephone visits despite multiple attempts.
The QuickDASH is an 11-item questionnaire that measures physical function and symptoms in individuals with one or more upper-limb musculoskeletal disorders. It includes a disability/symptom section (11 items, scored 1-5) and optional work or sport/music modules (4 items each, scored 1-5). Each response option is associated with a percentage value on a 0-100 scale: 1 (no symptoms) = 0.0, 2 (mild symptoms) = 2.3, 3 (moderate symptoms) = 4.5, 4 (severe symptoms) = 6.8, and 5 (extreme symptoms) = 9.1. After all questions are scored, the item scores are summed and divided by 100 to generate the final percentage score. Scores range from 0% to 100%, where 0% is the most favorable outcome, indicating no symptoms or limitations in physical activities, and 100% is the least favorable outcome, indicating extreme symptoms and severe limitations in physical activities. Higher scores reflect greater disability and symptom severity.
Outcome measures
| Measure |
10 Units of BT Per Digit
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
20 Units of BT Per Digit
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
Placebo
n=8 Participants
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations such that the investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
|
|---|---|---|---|
|
QUICK Dash Assessment
Week 4
|
37.64 percentage score
Standard Deviation 3.72
|
37.23 percentage score
Standard Deviation 3.74
|
29.11 percentage score
Standard Deviation 3.77
|
|
QUICK Dash Assessment
Week 12
|
27.10 percentage score
Standard Deviation 4.60
|
36.62 percentage score
Standard Deviation 4.91
|
34.68 percentage score
Standard Deviation 4.93
|
|
QUICK Dash Assessment
Week 16
|
27.73 percentage score
Standard Deviation 22.92
|
38.64 percentage score
Standard Deviation 15.41
|
32.20 percentage score
Standard Deviation 31.31
|
|
QUICK Dash Assessment
Week 24
|
32.20 percentage score
Standard Deviation 4.75
|
40.70 percentage score
Standard Deviation 5.08
|
25.37 percentage score
Standard Deviation 4.79
|
|
QUICK Dash Assessment
Week 20
|
31.82 percentage score
Standard Deviation 23.36
|
42.27 percentage score
Standard Deviation 12.31
|
33.18 percentage score
Standard Deviation 30.47
|
Adverse Events
10 Units of BT Per Digit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
20 Units of BT Per Digit
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
10 Units of BT Per Digit
n=8 participants at risk
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
20 Units of BT Per Digit
n=8 participants at risk
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations, investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
Botulinum toxin: Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects were randomized 1:1:1 into three different groups: 1) placebo, 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
|
Placebo
n=8 participants at risk
Before injection, patients waited in a temperature-controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. After randomization, BT was reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations such that the investigating hand surgeon was sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT was sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head was used as a standardized anatomic landmark for injection, both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize the probability of proper anatomic placement of the drug.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hand Weakness
|
0.00%
0/8 • : Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 24
|
12.5%
1/8 • Number of events 1 • : Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 24
|
25.0%
2/8 • Number of events 2 • : Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 24
|
|
Musculoskeletal and connective tissue disorders
Cyst like lesion
|
0.00%
0/8 • : Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 24
|
12.5%
1/8 • Number of events 2 • : Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 24
|
0.00%
0/8 • : Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place