Phase 2
Completed N=48
A Two-Part Study of BOTOX® Therapy for Ischemic Digits
Raynaud's Disease
Source: ClinicalTrials.gov NCT01309802 ↗
Enrolled (actual)
48
Serious AEs
14.6%
Results posted
Jun 2017
Primary outcomePrimary: Percentage of Patient Reported Pain-free Days — 12; 48 percentage of pain free days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patient Reported Pain-free Days |
12; 48 | — |
| SECONDARY Pain Related Quality of Life |
— | — |
| SECONDARY Hand Function |
— | — |
| SECONDARY Patient Satisfaction |
12; 48 | — |
| SECONDARY Tissue Perfusion |
— | — |
| SECONDARY EQ-5D A Standardised Patient Reported Measure of Health Status for Clinical and Economic Appraisal |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT01309802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.