Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's Syndrome

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blinded, clinical trial assessing the therapeutic efficacy of Botulinum toxin A (Onabotulinumtoxin A) in treating scleroderma-associated Raynaud's syndrome. Each patient will undergo injection with a treatment dose of Botulinum toxin A in one randomly-selected hand, and the contralateral hand will be injected with sterile saline (placebo) to serve as a control.

Study participants at the first study visit will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging to assess blood flow. After this initial assessment, the patients will undergo peri-arterial injection of Botulinum toxin A in one hand, and of sterile saline solution (placebo) in the other, in a randomized, blinded manner.

Patient will report the severity of their Raynaud's symptoms weekly over the four month study period. At one month post-injection, the patient will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging. At four months post-injection, the patient will again complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging. In addition, patient will be given the option of one week post-injection visit, at which point the same assessment will be performed.

At the conclusion of the study, unblinding will occur.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Aged 18 years and older

• Diagnosed with scleroderma.

• Symptoms of Raynaud's syndrome affecting both hands (not necessarily to equal extents)

• Ability to return/be available for follow-up evaluations

• Able and willing to give informed consent

• Able to speak and read in the English language.

Exclusion Criteria:

• A history of Myasthenia gravis.

• Reported allergy or hypersensitivity to any Botulinum toxin preparation.

• Active infection in either hand.

• Patients who have ever received Botulinum toxin vaccine.

• Pregnant or lactating women.

• Females unable or unwilling to maintain abstinence or use contraception for 28 days following the injections.

• Patients who have previously undergone any vascular surgery on the upper extremity, including surgical sympathectomies.

• Current use of any aminoglycoside antibiotic