Your session is about to expire
← Back to Search
Neurotoxin
Botulinum Toxin for Raynaud's Disease
Phase 4
Recruiting
Led By Paul A Ghareeb, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with 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.
Age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
Study Summary
This trial is testing whether Botulinum toxin can help people with Raynaud's Phenomenon who haven't responded to other treatments.
Who is the study for?
This trial is for adults over 18 with moderate to severe Raynaud's Phenomenon (RP) that hasn't improved after 3 months of standard treatment, or those with severe RP showing tissue loss. It excludes anyone under 18, recent changes in RP meds, past year BT treatments for RP, prior surgery for RP, or active infection/allergy at the injection site.Check my eligibility
What is being tested?
The study aims to test the effectiveness of Botulinum toxin (BT) in treating Raynaud's Phenomenon that doesn't respond well to usual treatments. The focus is on both objective and subjective outcomes to see how well BT works.See study design
What are the potential side effects?
Possible side effects from Botulinum toxin may include pain at the injection site, muscle weakness near where the medicine was injected, flu-like symptoms, eye dryness or tearing if injections are near your eyes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My severe Raynaud's phenomenon hasn't improved after 3 months of treatment.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in finger temperature measure
Change in tissue Oximetry measure for each finger
Secondary outcome measures
Changes in Hand subjectivity value
Changes in PROMIS Pain Interference scale
Changes in QUICK Dash assessment
+2 moreTrial Design
3Treatment groups
Active Control
Group I: 10 units of BT per digitActive Control1 Intervention
Prior to injection, patients will wait in a temperature controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. Once a patient is randomly selected via our randomization process, BT will be reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations such that the investigating hand surgeon who will be performing the injection will be sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT will be sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head will be used as a standardized anatomic landmark for injection both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize probability of proper anatomic placement of the drug.
Group II: PlaceboActive Control1 Intervention
Prior to injection, patients will wait in a temperature controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. Once a patient is randomly selected via our randomization process, BT will be reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations such that the investigating hand surgeon who will be performing the injection will be sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT will be sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head will be used as a standardized anatomic landmark for injection both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize probability of proper anatomic placement of the drug.
Group III: 20 units of BT per digitActive Control1 Intervention
Prior to injection, patients will wait in a temperature controlled room for 30 minutes in order to allow time for normalization of baseline digital temperature. Once a patient is randomly selected via our randomization process, BT will be reconstituted by clinic nursing staff with sterile saline per manufacturer recommendations such that the investigating hand surgeon who will be performing the injection will be sufficiently blinded. After proper cleansing of the skin with alcohol swabs, BT will be sterilely administered percutaneously via a small-gauge needle and syringe into the base of each digit by the investigating hand surgeons within the Upper Extremity Division. The volar metacarpal head will be used as a standardized anatomic landmark for injection both to lessen the probability and magnitude of risk to deep structures of the hand as well as maximize probability of proper anatomic placement of the drug.
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,639 Previous Clinical Trials
2,560,610 Total Patients Enrolled
American Society for Surgery of the HandOTHER
10 Previous Clinical Trials
1,045 Total Patients Enrolled
Paul A Ghareeb, MDPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I have been treated with BT for RP within the last year.I have not changed my RP treatment in the last 4 weeks.My severe Raynaud's phenomenon hasn't improved after 3 months of treatment.I have had surgery for Raynaud's phenomenon.I do not have an active infection at the treatment site.I am 18 years old or older.You are allergic to or cannot receive BT injections.
Research Study Groups:
This trial has the following groups:- Group 1: 10 units of BT per digit
- Group 2: Placebo
- Group 3: 20 units of BT per digit
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA sanction a dosage of 10 units BT for each finger?
"Our experts at Power conclude that administering 10 units of BT per digit is safe and score it a 3 on the safety scale. This treatment has been approved by Phase 4 trials, indicating its efficacy."
Answered by AI
What is the purpose of this medical research study?
"This trial's primary objective, to be evaluated at the Baseline, 4 weeks post injection, 12 weeks post injection and 24 weeks post injection time points is a Change in finger temperature measure. Secondary outcomes include changes in PROMIS Pain Interference scale (measuring pain hindrance on physical/mental activities), Hand subjectivity value (patients' assessment of their hand function from 0-100) and QUICK Dash Assessment (11 items for musculoskeletal disorders)."
Answered by AI
Is this research initiative still accepting participants?
"Yes, current records on clinicaltrials.gov demonstrate that this experiment is actively looking for participants. The trial was first released on February 10th 2022 and has since been amended the same day. This study seeks to recruit 36 patients from a singular location."
Answered by AI
What is the enrollment size of this clinical trial?
"Indeed, the data on clinicaltrials.gov verify that this research trial is actively recruitment participants - it was first posted on February 10th 2022 and its latest update also occurred in early February of 2021. Approximately 36 patients must be enrolled from a single medical site."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger