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Neurotoxin

Botulinum toxin type A for Cold Intolerance

Phase 1
Waitlist Available
Led By Jonathan M Winograd, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will study whether Botox can improve cold intolerance in patients who have had an amputation or replantation of a finger.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cold Intolerance Severity Score
quick dash
Secondary outcome measures
PHQ 9

Side effects data

From 2016 Phase 4 trial • 42 Patients • NCT02321436
7%
Head injury
7%
Insomnia
4%
Pain
4%
Asthma
4%
Tachycardia
4%
Constipation
4%
Pyrexia
4%
Cough
4%
Hypertensive crisis
4%
Pneumonia
4%
Vomiting
4%
Fall
4%
Hypokalaemia
4%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dysport ® 500 U
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BotoxExperimental Treatment1 Intervention
The patients in this arm will receive Botox injection to the digital arteries of all affected digits.
Group II: PlaceboPlacebo Group1 Intervention
The patients in this arm will receive placebo injection of saline to the digital arteries of all affected digits.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum toxin type A
2011
Completed Phase 4
~2730

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,473 Total Patients Enrolled
AllerganIndustry Sponsor
781 Previous Clinical Trials
276,541 Total Patients Enrolled
Jonathan M Winograd, MDPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical research embrace individuals in their senior years?

"According to the trial's qualification standards, suitable candidates must be aged between 18 and 75. Simultaneously, 6 trials are being conducted for participants under 18 years old while 57 study programs target those older than 65."

Answered by AI

Is this inquiry actively recruiting new participants?

"Evident on clinicaltrials.gov, this investigation is not accepting any further participants at the present moment; it was initially posted June 2nd of 2021 and most recently updated August 22nd 2022. Although applicants are no longer needed for this trial, there are currently 62 other medical studies that require enrolment."

Answered by AI

What medical ailments does Botox typically treat?

"Botox is well known for its ability to treat urinary incontinence. Additionally, it may be prescribed by doctors as a form of intervention for spinal cord dysfunction and overactive bladder syndrome (OABs)."

Answered by AI

Has research been conducted that looks at the potential uses of Botox?

"As of now, 61 clinical trials utilizing Botox are underway with 20 in their final phase. Most studies related to this medication are based out of Farmington Hills, Michigan but there exist 754 other research sites conducting experiments involving the drug."

Answered by AI

To what extent are participants engaging in this clinical research?

"This trial has since concluded its recruitment stage. It was first posted on June 2nd 2021 and most recently updated on August 22nd 2022. For those still seeking to participate in a similar study, there is one active clinical trial for cold intolerance and 61 studies recruiting participants for Botox treatments."

Answered by AI

What qualifications must participants possess to be eligible for this investigation?

"To enroll in this medical experiment, participants must be between 18 to 75 years old and demonstrate cold intolerance. This clinical trial is expected to admit 28 individuals in total."

Answered by AI

Is Botox a viable option for patients with safety in mind?

"Limited trials have been conducted in the past to assess Botox's safety and efficacy, thus it was assigned a score of 1."

Answered by AI
~7 spots leftby Apr 2025