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Phase 3 N=80 Randomized Quadruple-blind Treatment

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

Scleroderma · Raynaud's Syndrome

Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Change in Digital Blood Flow From Pre- to Post-injection. — -36.19; -6.10 Blood flow, measured in LDI flux units,

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Onabotulinumtoxin A (Drug); sterile saline solution (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Johns Hopkins University
Primary completion
Sep 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Digital Blood Flow From Pre- to Post-injection.
-36.19; -6.10
SECONDARY
Rate of Change in Raynaud's Phenomenon Symptoms Measured With the Raynaud's Condition Score.
-0.18; -0.14
SECONDARY
Number of Ulcers as Measure of Digital Ulcer Healing
0.45; 0.53
SECONDARY
Assessment of Raynaud's Symptoms Severity Using the Quick-DASH Score.
26.96; 29.11
SECONDARY
Assessment of Raynaud's Symptom Severity Using the McCabe Cold Sensitivity Score.
185.31; 187.19
SECONDARY
Assessment of Raynaud's Symptom Severity Using the VAS for Pain.
2.68; 3.05

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02165111). 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.

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