What side effects are associated with this type of intervention?

Common treatments for Raynaud's Disease include calcium channel blockers, phosphodiesterase inhibitors, and Botulinum toxin injections. Calcium channel blockers can cause side effects such as headache, flushing, and ankle swelling. Phosphodiesterase inhibitors may lead to headaches, dizziness, and gastrointestinal disturbances. Botulinum toxin injections, which block acetylcholine release leading to muscle relaxation and vasodilation, can cause localized pain, bruising, and muscle weakness at the injection site. In rare cases, systemic effects like difficulty swallowing or breathing may occur.

What prior FDA approvals exist?

The FDA has approved several treatments for Raynaud's Disease, primarily focusing on vasodilation and improving blood flow. Calcium channel blockers, such as nifedipine, are commonly used to relax blood vessels. Other treatments include vasodilators like nitroglycerin ointment and phosphodiesterase inhibitors such as sildenafil. While Botulinum toxin, which blocks acetylcholine release to cause muscle relaxation and vasodilation, is being studied for its efficacy in treatment-refractory Raynaud's Phenomenon, it is not yet FDA-approved specifically for this condition.

What other types of research exist?

Promising alternatives to Botulinum toxin for Raynaud's Disease include Sildenafil and Bosentan combined therapy, which has shown efficacy in improving vascular conditions related to systemic sclerosis, and calcium channel blockers like amlodipine, which help manage vasospasm.

← 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

Must not have

Patients under the age of 18

Patients who have undergone prior digital sympathectomy surgery for RP

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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to test if Botox can help patients with severe Raynaud's Phenomenon who don't respond to other treatments. Botox is injected into the fingers to relax muscles around blood vessels, improving blood flow and reducing symptoms like pain and tissue damage. Botox has been used primarily for treating facial wrinkles and has shown effectiveness in treating excessive underarm sweating.

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.

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.

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 below

Select...

My severe Raynaud's phenomenon hasn't improved after 3 months of treatment.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Select...

I have had surgery for Raynaud's phenomenon.

Select...

I do not have an active infection at the treatment site.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in finger temperature measure

Change in tissue Oximetry measure for each finger

Secondary study objectives

Changes in Hand subjectivity value

Changes in PROMIS Pain Interference scale

Changes in QUICK Dash assessment

+2 more

Awards & Highlights

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.

Trial 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

Group III: 20 units of BT per digitActive Control1 Intervention

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Botulinum toxin, a common treatment for Raynaud's Disease, works by blocking the release of acetylcholine, leading to muscle relaxation and vasodilation. This mechanism is crucial for Raynaud's Disease patients as it helps counteract the vasospastic episodes that restrict blood flow to extremities, causing pain and discoloration. By promoting vasodilation, botulinum toxin can alleviate symptoms and improve the quality of life for those with treatment-refractory Raynaud's Disease.

Right ventricular failure management.Effects of antihypertensive treatment on endothelial function.Endothelial and adrenergic dysfunction in Raynaud's phenomenon and scleroderma.