Study Summary
This trial is testing whether Botulinum toxin can help people with Raynaud's Phenomenon who haven't responded to other treatments.
Eligible Conditions
- Raynaud's Disease
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
2 Primary · 5 Secondary · Reporting Duration: Performed at 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks. Week 16 and week 20 measurements will be performed via telephone interview.
Week 24
Change in finger temperature measure
Change in tissue Oximetry measure for each finger
Week 24
Changes in Hand subjectivity value
Changes in PROMIS Pain Interference scale
Changes in QUICK Dash assessment
Changes in Raynaud Condition Score
Changes in Visual Analog Scale (VAS) pain score
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
3 Treatment Groups
10 units of BT per digit
1 of 3
20 units of BT per digit
1 of 3
Placebo
1 of 3
Active Control
36 Total Participants · 3 Treatment Groups
Primary Treatment: 10 units of BT per digit · No Placebo Group · Phase 4
10 units of BT per digit
Drug
ActiveComparator Group · 1 Intervention: Botulinum toxin · Intervention Types: Drug20 units of BT per digit
Drug
ActiveComparator Group · 1 Intervention: Botulinum toxin · Intervention Types: DrugPlaceboNoIntervention Group · 1 Intervention: Placebo · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: performed at 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks. week 16 and week 20 measurements will be performed via telephone interview.
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,509 Previous Clinical Trials
2,706,133 Total Patients Enrolled
American Society for Surgery of the HandOTHER
8 Previous Clinical Trials
995 Total Patients Enrolled
Paul A Ghareeb, MDPrincipal InvestigatorEmory University
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have moderate to severe RP that is not controlled after 3 months of standard medical therapy as prescribed by a Rheumatologist, or severe RP with evidence of tissue loss.
Who else is applying?
What state do they live in?
| New York | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
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Conditions
Cancer Related
Treatments