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Neurotoxin

Botulinum Toxin for Post Traumatic Stiffness

N/A
Waitlist Available
Led By Melvin Rosenwasser, MD
Research Sponsored by Columbia University
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 1 year post-op
Awards & highlights
All Individual Drugs Already Approved

Summary

This is a randomized double blind placebo controlled study to investigate the hypothesis that injection of botulinum toxin A into the muscles surrounding the elbow following the surgical treatment of an elbow fracture will reduce postoperative stiffness and improve function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
Secondary study objectives
Broberg Morrey Composite Elbow Function Score
Elbow Range of Motion

Side effects data

From 2010 Phase 4 trial • 50 Patients • NCT01004042
4%
Edema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Non Depressed Subjects
Depressed Subjects

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Botulinum ToxinExperimental Treatment1 Intervention
100 U injected into biceps, 100 U into brachialis
Group II: SalinePlacebo Group1 Intervention
100 U injected into biceps, 100 U into brachialis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum toxin type A
FDA approved

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,490 Previous Clinical Trials
2,663,946 Total Patients Enrolled
AllerganIndustry Sponsor
781 Previous Clinical Trials
276,667 Total Patients Enrolled
Melvin Rosenwasser, MDPrincipal InvestigatorColumbia University
~1 spots leftby Dec 2025
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