The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon
Primary Purpose
Raynaud Phenomenon
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AbobotulinumtoxinA
Saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Raynaud Phenomenon focused on measuring Raynaud Phenomenon, AbobotulinumtoxinA
Eligibility Criteria
Inclusion Criteria:
- Male or female adult between 18 and 80 years of age
- Must have health insurance
- Must have a current diagnosis of Raynaud's phenomenon
Exclusion Criteria:
- Allergy to abobotulinum toxin A or its components
- Diagnosis of myasthenia gravis
- Previously received abobotulinum toxin vaccine
- Previously undergone upper extremity vascular surgery (including surgical sympathectomy)
- Currently receiving aminoglycoside antibiotics
- Received abobotulinum toxin A treatment in either hand in the past 6 months
- Pregnant women
- Women currently breastfeeding
- Current tobacco smoker (use in the past 12 months)
- Unable to read and speak English
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
Sites / Locations
- UCF Health Lake Nona Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Abobotulinum toxin A
Saline solution
Arm Description
Injection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand.
Injection of 10 ml of non-bacteriostatic normal saline to chosen hand.
Outcomes
Primary Outcome Measures
Raynaud's Condition Score
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03639766
First Posted
August 17, 2018
Last Updated
June 9, 2021
Sponsor
University of Central Florida
1. Study Identification
Unique Protocol Identification Number
NCT03639766
Brief Title
The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon
Official Title
The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Time and resource constraints
Study Start Date
August 31, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Central Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to investigate the effect of abobotulinum toxin A on the symptoms of Raynaud's phenomenon.
Detailed Description
This prospective double-blind randomized control trial seeks to compare a single formulation of BoNT, aboboutlinum toxin A (Dysport), to a placebo saline group, studying the effect of BoNT on Raynaud's symptoms among a more diverse population to provide insight into the patients most likely to benefit from BoNT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud Phenomenon
Keywords
Raynaud Phenomenon, AbobotulinumtoxinA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This is a two-arm parallel assignment involves two groups of participants. One group/hand receives the abobotulinum toxin A, and the other group/hand receives a saline solution (control).
Masking
ParticipantInvestigator
Masking Description
This is a double-blind placebo-controlled trial.
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abobotulinum toxin A
Arm Type
Experimental
Arm Description
Injection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand.
Arm Title
Saline solution
Arm Type
Placebo Comparator
Arm Description
Injection of 10 ml of non-bacteriostatic normal saline to chosen hand.
Intervention Type
Drug
Intervention Name(s)
AbobotulinumtoxinA
Intervention Description
AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution
Intervention Type
Other
Intervention Name(s)
Saline solution
Intervention Description
Non-bacteriostatic saline solution
Primary Outcome Measure Information:
Title
Raynaud's Condition Score
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female adult between 18 and 80 years of age
Must have health insurance
Must have a current diagnosis of Raynaud's phenomenon
Exclusion Criteria:
Allergy to abobotulinum toxin A or its components
Diagnosis of myasthenia gravis
Previously received abobotulinum toxin vaccine
Previously undergone upper extremity vascular surgery (including surgical sympathectomy)
Currently receiving aminoglycoside antibiotics
Received abobotulinum toxin A treatment in either hand in the past 6 months
Pregnant women
Women currently breastfeeding
Current tobacco smoker (use in the past 12 months)
Unable to read and speak English
Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Prisoners
Facility Information:
Facility Name
UCF Health Lake Nona Office
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon
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