Botulinum Toxin Injections for Thoracic Outlet Syndrome

• Status: Unknown status
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Botulinum toxin type A injected into the anterior and middle scalene muscles will reduce the irritation on the neurovascular structures at the interscalene triangle in subjects with TOS. This will lead to reductions in pain and paresthesias, and improvements in function when compared with injection of placebo.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborator: Merz Pharmaceuticals
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Age at least 19 years

• Medically stable

• Able to give informed consent

• Meets criteria for clinical diagnosis of TOS

• Symptoms of TOS present for at least three months and less than two year

• Have had EMG studies and a CT or MRI scan of the cervical spine

Exclusion Criteria:

• Prior treatment with BTX-A

• Allergy to BTX-A

• History of botulinum toxicity

• Prior scalenectomy

• Surgery for TOS planned within four months

• Use of blood thinners, i.e., warfarin; unfractionated or low molecular weight heparin

• History of Myasthenia Gravis, Eaton-Lambert Syndrome or Shy-Drager Syndrome

• Unable to complete follow-up assessments at 6 weeks and 4 months

• Any abnormalities on EMG, CT or MRI studies suggesting an alternate diagnosis

• Pregnancy or planned pregnancy within six months