The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon

Raynaud Phenomenon Clinical Trial

Official title:

The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03639766
• Other study ID #: BIO-18-14092
• Status: Terminated
• Phase: Phase 4
• Start date: August 31, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: June 2021
• Source: University of Central Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the effect of abobotulinum toxin A on the symptoms of Raynaud's phenomenon.

Description:

This prospective double-blind randomized control trial seeks to compare a single formulation of BoNT, aboboutlinum toxin A (Dysport), to a placebo saline group, studying the effect of BoNT on Raynaud's symptoms among a more diverse population to provide insight into the patients most likely to benefit from BoNT.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female adult between 18 and 80 years of age

• Must have health insurance

• Must have a current diagnosis of Raynaud's phenomenon

Exclusion Criteria:

• Allergy to abobotulinum toxin A or its components

• Diagnosis of myasthenia gravis

• Previously received abobotulinum toxin vaccine

• Previously undergone upper extremity vascular surgery (including surgical sympathectomy)

• Currently receiving aminoglycoside antibiotics

• Received abobotulinum toxin A treatment in either hand in the past 6 months

• Pregnant women

• Women currently breastfeeding

• Current tobacco smoker (use in the past 12 months)

• Unable to read and speak English

• Adults unable to consent

• Individuals who are not yet adults (infants, children, teenagers)

• Prisoners

Related Conditions & MeSH terms

• Raynaud Disease
• Raynaud Phenomenon

Intervention

Drug:
• AbobotulinumtoxinA
AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution

Other:
• Saline solution
Non-bacteriostatic saline solution

Locations

Country	Name	City	State
United States	UCF Health Lake Nona Office	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Central Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Raynaud's Condition Score	Raynaud's Condition Score is a validated outcome measure used to assess a person's functionality owing to their Raynaud's symptoms. 0 to 10, with 0 being no symptoms and 10 being more severe symptoms of Raynaud's.	12 months