Botulinum Toxin in the Treatment of Raynaud's
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Purpose
The investigators are studying a medical condition known as Raynaud's Phenomenon (RP). RP is a painful condition in which cold surroundings or stressful events trigger pain, a cold sensation, and in severe cases, sores and ulcers on one's fingers. The investigators think that RP results from problems with some of the components of the blood vessels, surrounding nerves, and some of the circulating messengers in the bloodstream. Although there are many different medicines that are currently used to treat RP, the investigators have not yet found a cure for severe cases of this condition. Furthermore, the investigators have found few medicines that show consistent healing of the ulcers that may be associated with RP. Some of the treatments include medicines that are used to treat high blood pressure known as calcium channel blockers. Medications that thin the blood (anticoagulants) such as aspirin have also been used to treat RP.
In this study, the investigators will investigate a new treatment for RP known as Botulinum toxin A. Botulinum toxin is a chemical that is temporarily toxic to nerves, but has been approved by the government for the treatment of several other conditions including but not limited to: excessive sweating, neck pain associated with a condition known as cervical dystonia, uncontrollable forcible closure of the eyelids known as blepharospasm, and a condition known as strabismus in which the eyes are not in alignment with one another.
This study will aim to greatly improve the quality of life and pain associated with RP. Previous studies also support the chance that Botulinum toxin will help to heal some of the ulcers associated with RP. Although there is no current standard of care, many of the patients in the study will have already failed or are unable to tolerate commonly used treatments such as lifestyle modifications, calcium channel blockers, nitroglycerin, and anticoagulants. If the patient chooses to participate in the study, he/she will be randomly assigned to receive an injection with Botulinum toxin in either the left or right hand. The other hand will be injected with saline solution. Neither the patient nor the physician or research personnel seen in follow-up will know which hand is injected with Botulinum toxin.
| Condition | Intervention |
|---|---|
|
Raynaud's Syndrome |
Drug: botulinum toxin A |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Botulinum Toxin in the Treatment of Raynaud's |
- Mean Digital Temperature Difference From Baseline [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Each digit temperature was measured and recorded at baseline, and then measured and re-recorded after 3 minute intervals following a 20 second 4 degree Celsius ice bath immersion.
| Enrollment: | 10 |
| Study Start Date: | October 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Botox
single-drug dosage comparison cross-over study
|
Drug: botulinum toxin A
Botulinum toxin A will be injected into participants hand total 40units
|
Eligibility| Ages Eligible for Study: | 18 Years to 89 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:Adult (>18 years) patients with severe RP of any etiology will be invited to participate. Inclusion criteria include a) history of digital infarcts or ulcerations, b) unresponsive to standard therapies, or c) impending potential for digital amputation. Patients on other standard therapies such as antiplatelet agents, vasodilators, and calcium channel blockers will be included. -
Exclusion Criteria:Pregnancy, mild disease, patients with myasthenia gravis, botulinum toxin allergy, and phobia of needles are exclusion criteria. Women of childbearing age will need to demonstrate a negative urine pregnancy test. Myasthenia gravis is excluded because underlying generalized weakness can be exacerbated, and local weakness at injection sites can occur more than otherwise expected.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01233999
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: | Suephy C Chen, MD | Emory University |
More Information
| Responsible Party: | Suephy Chen, MD, Associate Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT01233999 History of Changes |
| Other Study ID Numbers: | IRB00015510 |
| Study First Received: | November 2, 2010 |
| Results First Received: | July 17, 2013 |
| Last Updated: | March 15, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
Scleroderma Raynaud's Syndrome |
Additional relevant MeSH terms:
|
Raynaud Disease Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases Botulinum Toxins Botulinum Toxins, Type A AbobotulinumtoxinA OnabotulinumtoxinA IncobotulinumtoxinA |
Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on September 27, 2016