Raynaud PhenomenonPhase 4NCT03639766
The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon
A Phase 4 study testing AbobotulinumtoxinA and Saline solution in people with Raynaud Phenomenon, run by University of Central Florida at 1 site in United States.
Trial summary
This study aims to investigate the effect of abobotulinum toxin A on the symptoms of Raynaud's phenomenon. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Raynaud Phenomenon
- What is being tested?
- AbobotulinumtoxinA and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2018to 31 Jan 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female adult between 18 and 80 years of age
- Must have health insurance
- Must have a current diagnosis of Raynaud's phenomenon
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Raynaud Phenomenon
- Being tested
- AbobotulinumtoxinA, Saline solution
- Keywords
- Raynaud Phenomenon, AbobotulinumtoxinA
- Medical subject headings
- Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbobotulinumtoxinADrug
AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution
Saline solutionOther
Non-bacteriostatic saline solution
| Study group | Role | What they receive |
|---|---|---|
| Abobotulinum toxin A | Experimental | Injection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand. Receives: Drug: AbobotulinumtoxinA |
| Saline solution | Placebo comparator | Injection of 10 ml of non-bacteriostatic normal saline to chosen hand. Receives: Other: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start31 Aug 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Why it stopped: Time and resource constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Raynaud PhenomenonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Weinstein, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639766
- Sponsor's protocol ID
- BIO-18-14092
- Status last verified
- Jun 2021
- First submitted
- 17 Aug 2018
- Last updated
- 30 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT03639766
- Acronym / sponsor ID
- BIO-18-14092
- Conditions
- Raynaud Phenomenon
- Keywords
- Raynaud Phenomenon, AbobotulinumtoxinA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Time and resource constraints
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Posted 30 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effect of abobotulinum toxin A on the symptoms of Raynaud's phenomenon.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Abobotulinum toxin A | Experimental | Drug: AbobotulinumtoxinAInjection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand. |
| Saline solution | Placebo comparator | Other: Saline solutionInjection of 10 ml of non-bacteriostatic normal saline to chosen hand. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female adult between 18 and 80 years of age
- Must have health insurance
- Must have a current diagnosis of Raynaud's phenomenon
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbobotulinumtoxinAAbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution | Drug | Abobotulinum toxin A |
| Saline solutionNon-bacteriostatic saline solution | Other | Saline solution |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AbobotulinumtoxinA and Saline solution in people with Raynaud Phenomenon, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Raynaud's Condition Score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.