A Two-Part Study of BOTOX® Therapy for Ischemic Digits
Condition: Raynaud's Disease
MeSH terms: Raynaud Disease
Intervention: onabotulinum toxin type-A
Intervention description: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: botox; raynaud's; botulinum toxin; botulinum toxin A; raynaud's disease; raynaud's syndrome; raynaud's phenomenon; ischemic digits; ischemia; botox treatment; onabotulinum; onabotulinum toxin; onabotulinum toxin type A

Summary:

      Treating patients with Raynaud's phenomenon who have chronic pain and ulcerations is
      extremely challenging. Published reports and our previous work support our hypothesis that
      symptomatic patients experience relief of pain and healing of ulcerations with minimal
      adverse effects when treated with botulinum toxin type A (Btx-A) injections for Raynaud's
      phenomenon. The proposed study is the first clinical trial and prospective study designed to
      document whether or not 1) Btx-A injection relieves pain in a patient's hand affected with
      Raynaud's disease better than a placebo within 28 days of injection, and 2) Btx-A injection
      relieves pain associated with Raynaud's disease for longer than 28 days, improving patients'
      quality of life. Through this study we intend to further determine the effect of injected
      Btx-A on relieving chronic pain and ulcerations to the ischemic hand while characterizing the
      patients for whom this treatment is most effective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  aged 18-75 years

          -  diagnosed with Raynaud's disease/phenomenon

          -  ischemia not due to peripheral artery disease or other vascular disease

          -  otherwise healthy individual

          -  up-to-date tetanus immunization

          -  ability to return/be available for follow-up evaluations

          -  ability/willingness to give informed consent

        Exclusion Criteria:

          -  HIV/AIDS positive or otherwise immunocompromised

          -  history of neuromuscular disease

          -  reported allergy to BOTOX®; reported allergy to lidocaine or other local anesthetic
             agent

          -  ever received botulinum toxin vaccine

          -  ultrasound or angiogram showing digital ischemia due to blocked vessel and not
             Raynaud's disease

          -  history or symptoms of any significant medical problem in the last year (i.e.,
             bradycardia, impaired cardiovascular function, liver disease)

          -  symptoms of infection or illness during initial enrollment

          -  pregnant or lactating women

          -  unable or unwilling to maintain abstinence or use contraception for 28 days following
             all injections

          -  cognitive impairment