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

June 9, 2021 updated by: David Weinstein, University of Central Florida

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32827
        • UCF Health Lake Nona Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abobotulinum toxin A
Injection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand.
Drug: AbobotulinumtoxinA
AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution
Placebo Comparator: Saline solution
Injection of 10 ml of non-bacteriostatic normal saline to chosen hand.
Other: Saline solution
Non-bacteriostatic saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Raynaud's Condition Score
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Central Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2018

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

August 17, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO-18-14092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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