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Time and resource constraints
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This study aims to investigate the effect of abobotulinum toxin A on the symptoms of Raynaud's phenomenon.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abobotulinum toxin A | Experimental | Injection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand. |
|
| Saline solution | Placebo Comparator | Injection of 10 ml of non-bacteriostatic normal saline to chosen hand. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AbobotulinumtoxinA | Drug | AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCF Health Lake Nona Office | Orlando | Florida | 32827 | United States |
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The study had to be close early due to lack of support and time resulting in a lower number of participants than hoped for.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | score on a scale | 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abobotulinum Toxin A | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hand Weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Hand muscle weakness |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Weinstein | University of Central Florida | (407)266-4900 | david.weinstein@ucf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2018 | May 14, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 21, 2019 | May 14, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011928 | Raynaud Disease |
| ID | Term |
|---|---|
| D000090122 | Livedoid Vasculopathy |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C542869 | abobotulinumtoxinA |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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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).
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This is a double-blind placebo-controlled trial.
| Saline solution | Other | Non-bacteriostatic saline solution |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | Saline Solution | Injection of 10 ml of non-bacteriostatic normal saline to chosen hand. Saline solution: Non-bacteriostatic saline solution | 0 | 3 | 0 | 3 | 0 | 3 |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |