10 units of BT per digit for Raynaud's Disease

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Raynaud's DiseaseBotulinum toxin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

3 of 3
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

3 of 3
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: Drug
20 units of BT per digit
Drug
ActiveComparator Group · 1 Intervention: Botulinum toxin · Intervention Types: Drug
PlaceboNoIntervention 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 York100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%