Study of the Safety and Efficacy of Botox in Bruxism

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether botulinum toxin helps patients with bruxism.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• 1. Patients between the ages of 18 and 80 years old with a diagnosis of bruxism, based on the standard criteria.

• 2. If the subject is a female of childbearing age, she must have had a hysterectomy, tubal ligation, or otherwise be incapable of pregnancy, or have practiced a method of contraception (hormonal contraceptives, spermicidal barrier, intrauterine device, partner sterility) at least one month prior to study entry. Any female of childbearing age will have a urine pregnancy test one week prior to the treatment (visit 2).

• 3. Ability of the patient or guardian to sign and understand informed consent.

• 4. Ability to follow and comply with study directions.

Exclusion Criteria:

• 1. Coexistence of active psychosis, other active psychiatric disease or cognitive impairment.

• 2. Coexistence of serious co-morbid conditions.

• 3. Exposure to any botulinum toxin preparation within the past 6 months.

• 4. Participation in another experimental therapeutic protocol within 30 days.

• 5. Any medical condition in which the administration of botulinum toxin is contraindicated, including myasthenia gravis, amyotrophic lateral sclerosis or other neuromuscular diseases.

• 6. History of dysphagia.

• 7. History of botulism.

• 8. A condition or situation in which the investigators view will confound the ability of the subject to participate in the study.

• 9. Patients or guardian who are unable to understand and sign informed consent.

• 10. Pregnancy

• 11. Patients who do not meet inclusion criteria.

• 12. Patients in whom it is felt that a major portion of overall sleep morbidity is not related to bruxism.