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

• Sponsor: University of Central Florida (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03639766
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arms: 2
• Actual Duration (Months): 17
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Raynaud Phenomenon	Drug: AbobotulinumtoxinA; Other: Saline solution	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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).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).
• Masking: Double (Participant, Investigator)
• Masking Description: This is a double-blind placebo-controlled trial.
• Primary Purpose: Treatment
• Official Title: The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial
• Actual Study Start Date: Aug 31, 2018
• Actual Primary Completion Date: Jan 31, 2020
• Actual Study Completion Date: Jan 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Raynaud's Condition Score [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCF Health Lake Nona Office	Orlando	Florida	United States	32827

Sponsors and Collaborators

• University of Central Florida

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 26, 2018
• Informed Consent Form - May 21, 2019

More Information

Publications

None provided.

• Responsible Party: David Weinstein, Assistant Professor of Dermatology, University of Central Florida
• ClinicalTrials.gov Identifier: NCT03639766
• Other Study ID Numbers: BIO-18-14092
• First Posted: Aug 21, 2018
• Last Update Posted: Jun 30, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by David Weinstein, Assistant Professor of Dermatology, University of Central Florida: Raynaud Phenomenon; AbobotulinumtoxinA
• Additional relevant MeSH terms: Raynaud Disease; abobotulinumtoxinA; Botulinum Toxins, Type A

Study Results

Participant Flow

Pre-assignment Detail	The study had to be close early due to lack of support and time resulting in a lower number of participants than hoped for.

Arm/Group Title	All Study Participants
Arm/Group Description	All study participants received an injection of Abobotulinum Toxin A into one hand. They received an injection of saline in the other hand. The Abobotulinum Toxin A injection solution consisted of 300 units in 10 ml of non-bacteriostatic normal saline. The saline injection consisted of 10 ml of non-bacteriostatic normal saline.
Period Title: Overall Study
STARTED	3
COMPLETED	3
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	All study participants received an injection of Abobotulinum Toxin A into one hand. They received an injection of saline in the other hand. The Abobotulinum Toxin A injection solution consisted of 300 units in 10 ml of non-bacteriostatic normal saline. The saline injection consisted of 10 ml of non-bacteriostatic normal saline.
Overall Participants	3
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 33.3%
>=65 years	2 66.7%
Sex: Female, Male (Count of Participants)
Female	3 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	3 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	3 100%

Outcome Measures

1. Primary Outcome

Title	Raynaud's Condition Score
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Abobotulinum Toxin A	Saline Solution
Arm/Group Description	Injection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand. AbobotulinumtoxinA: AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution	Injection of 10 ml of non-bacteriostatic normal saline to chosen hand. Saline solution: Non-bacteriostatic saline solution
Measure Participants	3	3
Baseline	1.3	1.3
3 Months	3	0.67
9 Months	1	1
12 Months	1.4	0.6

Adverse Events

Time Frame	1 year
Arm/Group Title	Abobotulinum Toxin A		Saline Solution
Arm/Group Description	Injection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand. AbobotulinumtoxinA: AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution		Injection of 10 ml of non-bacteriostatic normal saline to chosen hand. Saline solution: Non-bacteriostatic saline solution
All Cause Mortality
	Abobotulinum Toxin A		Saline Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)
Serious Adverse Events
	Abobotulinum Toxin A		Saline Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Abobotulinum Toxin A		Saline Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/3 (66.7%)		0/3 (0%)
Musculoskeletal and connective tissue disorders
Hand Weakness	2/3 (66.7%)	2	0/3 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.