Trial Outcomes & Findings for The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon (NCT NCT03639766)
NCT ID: NCT03639766
Last Updated: 2021-06-30
Results Overview
Raynaud's Condition Score is a validated outcome measure used to assess a person's functionality owing to their Raynaud's symptoms. 0 to 10, with 0 being no symptoms and 10 being more severe symptoms of Raynaud's.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
3 participants
Primary outcome timeframe
12 months
Results posted on
2021-06-30
Participant Flow
The study had to be close early due to lack of support and time resulting in a lower number of participants than hoped for.
Participant milestones
| Measure |
All Study Participants
All study participants received an injection of Abobotulinum Toxin A into one hand. They received an injection of saline in the other hand.
The Abobotulinum Toxin A injection solution consisted of 300 units in 10 ml of non-bacteriostatic normal saline.
The saline injection consisted of 10 ml of non-bacteriostatic normal saline.
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|---|---|
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Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
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3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon
Baseline characteristics by cohort
| Measure |
All Study Participants
n=3 Participants
All study participants received an injection of Abobotulinum Toxin A into one hand. They received an injection of saline in the other hand.
The Abobotulinum Toxin A injection solution consisted of 300 units in 10 ml of non-bacteriostatic normal saline.
The saline injection consisted of 10 ml of non-bacteriostatic normal saline.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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1 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Region of Enrollment
United States
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3 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 monthsRaynaud's Condition Score is a validated outcome measure used to assess a person's functionality owing to their Raynaud's symptoms. 0 to 10, with 0 being no symptoms and 10 being more severe symptoms of Raynaud's.
Outcome measures
| Measure |
Abobotulinum Toxin A
n=3 Participants
Injection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand.
AbobotulinumtoxinA: AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution
|
Saline Solution
n=3 Participants
Injection of 10 ml of non-bacteriostatic normal saline to chosen hand.
Saline solution: Non-bacteriostatic saline solution
|
|---|---|---|
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Raynaud's Condition Score
Baseline
|
1.3 score on a scale
Interval 0.0 to 4.0
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1.3 score on a scale
Interval 0.0 to 4.0
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Raynaud's Condition Score
3 Months
|
3 score on a scale
Interval 1.0 to 4.0
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0.67 score on a scale
Interval 0.0 to 2.0
|
|
Raynaud's Condition Score
9 Months
|
1 score on a scale
Interval 0.0 to 3.0
|
1 score on a scale
Interval 0.0 to 3.0
|
|
Raynaud's Condition Score
12 Months
|
1.4 score on a scale
Interval 0.0 to 3.3
|
0.6 score on a scale
Interval 0.0 to 1.0
|
Adverse Events
Abobotulinum Toxin A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Saline Solution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Abobotulinum Toxin A
n=3 participants at risk
Injection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand.
AbobotulinumtoxinA: AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution
|
Saline Solution
n=3 participants at risk
Injection of 10 ml of non-bacteriostatic normal saline to chosen hand.
Saline solution: Non-bacteriostatic saline solution
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|---|---|---|
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Musculoskeletal and connective tissue disorders
Hand Weakness
|
66.7%
2/3 • Number of events 2 • 1 year
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0.00%
0/3 • 1 year
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place