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NCT02165111 · ClinicalTrials.gov registry record · Phase 3
Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's Syndrome
A Phase 3 study of Scleroderma and Raynaud's Syndrome, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT02165111 is a Phase 3 study of Scleroderma and Raynaud's Syndrome that has completed, run by Johns Hopkins University. The registered enrollment target is 40 participants, below the 401-participant average among 23 other Scleroderma trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02165111, a Phase 3 study of Scleroderma and Raynaud's Syndrome, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, double-blinded, clinical trial assessing the therapeutic efficacy of Botulinum toxin A (Onabotulinumtoxin A) in treating scleroderma-associated Raynaud's syndrome. Each patient will undergo injection with a treatment dose of Botulinum toxin A in one randomly-selected hand, and the contralateral hand will be injected with sterile saline (placebo) to serve as a control. Study participants at the first study visit will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging to assess blood flow. After this initial assessment, the patients will undergo peri-arterial injection of Botulinum toxin A in one hand, and of sterile saline solution (placebo) in the other, in a randomized, blinded manner. Patient will report the severity of their Raynaud's symptoms weekly over the four month study period. At one month post-injection, the patient will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging. At four months post-injection, the patient will again complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging. In addition, patient will be given the option of one week post-injection visit, at which point the same assessment will be performed. At the conclusion of the study, unblinding will occur.
Conditions Studied
Interventions
- DRUG Onabotulinumtoxin A
- DRUG sterile saline solution
Study Locations (1)
Maryland
- Johns Hopkins Bayview Medical Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-01 |
| Est. Completion | 2015-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02165111
The ClinicalTrials.gov registry entry for NCT02165111 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 401-participant average among 23 other Scleroderma trials with a reported enrollment target (90% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Scleroderma appearing as the primary indexed condition, and to 2 interventions - of which Onabotulinumtoxin A is the first listed.
NCT02165111 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02165111 about?
NCT02165111 is a clinical study titled "Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's Syndrome". This is a randomized, double-blinded, clinical trial assessing the therapeutic efficacy of Botulinum toxin A (Onabotulinumtoxin A) in treating scleroderma-associated Raynaud's syndrome. Each patient will undergo injection with a treatment dose of Botulinum toxin A in one randomly-selected hand, and ...
What is the current status of trial NCT02165111?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2015-01. Estimated completion is 2015-09.
What conditions does trial NCT02165111 study?
This clinical trial studies the following conditions: Scleroderma, Raynaud's Syndrome.
What interventions are being tested in trial NCT02165111?
The interventions under investigation include: Onabotulinumtoxin A (DRUG), sterile saline solution (DRUG).
Who is sponsoring clinical trial NCT02165111?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02165111 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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