Botulinum Toxin Type A (Botox) for the Treatment of Cervical Dystonia and Upper Thoracic Muscular Pain

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the use of injections of Botox (botulinum toxin type A) for the treatment of chronic neck pain. Botox is an approved treatment for patients with cervical dystonia. Cervical dystonia is a chronic condition characterized by involuntary movements of the neck that are often painful. In this study, the response from Botox in patients with neck pain not associated with cervical dystonia will be compared to the pain response in patients with cervical dystonia.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Outpatient, male and female subjects, of any race, between 18 years of age and older. Female subjects of childbearing potential must have a negative urine pregnancy test result at the Screening/Baseline Visit. (A female is considered of childbearing potential unless she is postmenopausal or without a uterus and/or both ovaries.)

• Subjects suffering from cervicothoracic muscle pain with or without cervical dystonia. The pain must be of at least 3 months duration and characterized by a numerical pain rating score of at least 5 on the pain subscale of the TWSTR scale.

• Subjects who are able to understand the requirements of the study and sign an Informed Consent Form.

Exclusion Criteria:

• Female subjects who are pregnant (positive urine pregnancy test) or who have an infant they are breast-feeding or who are of childbearing potential and not practicing a reliable method of birth control (OCP or barrier).

• Subjects who have had standard trigger point injections with local anesthetics in the last 3 months.

• Subjects who have had chiropractic manipulation of the neck or upper thoracic region in the last 3 months or plan on having such manipulations during the study.

• Subjects, who by clinical evaluation and / or MRI study, are considered to have symptomatic cervical and/or thoracic disc pathology as primary etiology of their pain.

• Subjects whose cervical spine ROM is restricted in the setting of arthritic conditions (advanced osteoporosis, degenerative arthritis, ankylosing spondylitis).

• Significant medical or psychiatric comorbid disease, as deemed by the investigators

• Litigation involving the existence or cause for neck pain and/or headache

• Pending disability assessment

• Subjects with a diagnosis of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.

• Subjects currently using aminoglycoside antibiotics or agents that interfere with neuromuscular function.

• Subjects with profound atrophy or excessive weakness of the muscles in the target area(s) of injection.

• Subjects with an infection at the injection site or systemic infection (in this case, postpone study entry until one week following recovery).

• Subjects with an allergy or sensitivity to any component of the test medication.

• Subjects with a history of poor cooperation, non-compliance with medical treatment, or unreliability.

• Subjects currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of the Baseline Visit.