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

NCT03639766 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: BIO-18-14092
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Raynaud Phenomenon

Keywords

Raynaud Phenomenon; AbobotulinumtoxinA

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Abobotulinum toxin A

EXPERIMENTAL

Injection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand.

Drug: AbobotulinumtoxinA

Saline solution

PLACEBO COMPARATOR

Injection of 10 ml of non-bacteriostatic normal saline to chosen hand.

Other: Saline solution

Interventions

AbobotulinumtoxinA DRUG

AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution

Abobotulinum toxin A

Saline solution OTHER

Non-bacteriostatic saline solution

Saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adult between 18 and 80 years of age
• Must have health insurance
• Must have a current diagnosis of Raynaud's phenomenon

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Central Florida: lead

Study Sites (1)

UCF Health Lake Nona Office

Orlando, Florida, 32827, United States

Location

MeSH Terms

Conditions

Raynaud Disease

Interventions

abobotulinumtoxinA; Saline Solution

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. David Weinstein
• Organization: University of Central Florida

david.weinstein@ucf.edu

(407)266-4900

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind placebo-controlled trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Model Details: This is a two-arm parallel assignment involves two groups of participants. One group/hand receives the abobotulinum toxin A, and the other group/hand receives a saline solution (control).

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: August 31, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: June 30, 2021
• Results First Posted: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)