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NCT01233999 · ClinicalTrials.gov registry record · NA

Botulinum Toxin in the Treatment of Raynaud's

A NA study, sponsored by Emory University.

Completed
Registry status
NA
Development phase
10
Enrollment target

NCT01233999: Completed NA study, sponsored by Emory University.

NCT01233999 is a NA study that has completed, run by Emory University. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01233999, a NA study, has completed, sponsored by Emory University.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target

Study Summary

The investigators are studying a medical condition known as Raynaud's Phenomenon (RP). RP is a painful condition in which cold surroundings or stressful events trigger pain, a cold sensation, and in severe cases, sores and ulcers on one's fingers. The investigators think that RP results from problems with some of the components of the blood vessels, surrounding nerves, and some of the circulating messengers in the bloodstream. Although there are many different medicines that are currently used to treat RP, the investigators have not yet found a cure for severe cases of this condition. Furthermore, the investigators have found few medicines that show consistent healing of the ulcers that may be associated with RP. Some of the treatments include medicines that are used to treat high blood pressure known as calcium channel blockers. Medications that thin the blood (anticoagulants) such as aspirin have also been used to treat RP. In this study, the investigators will investigate a new treatment for RP known as Botulinum toxin A. Botulinum toxin is a chemical that is temporarily toxic to nerves, but has been approved by the government for the treatment of several other conditions including but not limited to: excessive sweating, neck pain associated with a condition known as cervical dystonia, uncontrollable forcible closure of the eyelids known as blepharospasm, and a condition known as strabismus in which the eyes are not in alignment with one another. This study will aim to greatly improve the quality of life and pain associated with RP. Previous studies also support the chance that Botulinum toxin will help to heal some of the ulcers associated with RP. Although there is no current standard of care, many of the patients in the study will have already failed or are unable to tolerate commonly used treatments such as lifestyle modifications, calcium channel blockers, nitroglycerin, and anticoagulants. If the patient chooses to participate in the study, he/she will be

Primary Outcome

Each digit temperature was measured and recorded at baseline, and then measured and re-recorded after 3 minute intervals following a 20 second 4 degree Celsius ice bath immersion.

Interventions

  • DRUG botulinum toxin A

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2010-10
Est. Completion 2012-03
Phase NA
Emory University

1,208 total trials

What the finished NCT01233999 record still lists

NCT01233999 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which botulinum toxin A is the first listed.

NCT01233999 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01233999 about?

NCT01233999 is a clinical study titled "Botulinum Toxin in the Treatment of Raynaud's". The investigators are studying a medical condition known as Raynaud's Phenomenon (RP). RP is a painful condition in which cold surroundings or stressful events trigger pain, a cold sensation, and in severe cases, sores and ulcers on one's fingers. The investigators think that RP results from problem...

What is the current status of trial NCT01233999?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2010-10. Estimated completion is 2012-03.

What interventions are being tested in trial NCT01233999?

The interventions under investigation include: botulinum toxin A (DRUG).

Who is sponsoring clinical trial NCT01233999?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01233999's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01233999, the US trial registry maintained by the National Library of Medicine. NCT01233999 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.