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

Completed · Phase 3 · Has a placebo group

Conditions studied: Scleroderma, Raynaud's Syndrome

In brief

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.

Key facts

Study ID

NCT02165111

Run by

Johns Hopkins University

People needed

40

Starts

2015-01-01

Expected to finish

2015-09-01

Last updated by the study team

2016-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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