Study of the Safety and Efficacy of Botox in Bruxism

NCT00908050 | Completed Phase 4 Results

• 1 other identifier: H-22737
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bruxism

Keywords

bruxism, botulinum toxin, sleep study

Outcome Measures

Primary Outcomes (1)

• Bruxism Questionnaire Baseline and at Week 4

  Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\]. This is compared to week 4 assessments. The bruxism questionnaire consists of 8 questions. Each question can be scored between 0-3 points for a total possible scoring of 24 points. The minimum score is 0. The maximum score if 24. A score of 3 or less means non-temporomandibular disorder. A score of 4 or more means temporomandibular disorder.

  baseline versus week 4

Secondary Outcomes (4)

• Headache Impact Test (HIT-6) Questionnaire Baseline and at Week 4

  Baseline to week 4

• Clinical Global Impression (CGI)

  baseline versus week 4

• Visual Analog Scale of Change (VAS)-Pain Scale

  baseline versus week 4

• Visual Analog Scale of Change (VAS)-Pain

  Baseline versus week 4

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo arm

Drug: Placebo arm

botulinum toxin type A

ACTIVE COMPARATOR

Active arm

Drug: Botulinum toxin type A

Interventions

Botulinum toxin type A DRUG

Patients are injected with botulinum toxin type A (BOTOX) 60 units in each masseter muscle and 35 in each temporalis muscle, bilaterally.

Also known as: Botulinum toxin type A (Botox)

botulinum toxin type A

Placebo arm DRUG

Placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients between the ages of 18 and 80 years old with a diagnosis of bruxism, based on the standard criteria.
• \. 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).
• \. Ability of the patient or guardian to sign and understand informed consent.
• \. Ability to follow and comply with study directions.

You may not qualify if:

• \. Coexistence of active psychosis, other active psychiatric disease or cognitive impairment.
• \. Coexistence of serious co-morbid conditions.
• \. Exposure to any botulinum toxin preparation within the past 6 months.
• \. Participation in another experimental therapeutic protocol within 30 days.
• \. Any medical condition in which the administration of botulinum toxin is contraindicated, including myasthenia gravis, amyotrophic lateral sclerosis or other neuromuscular diseases.
• \. History of dysphagia.
• \. History of botulism.
• \. A condition or situation in which the investigators view will confound the ability of the subject to participate in the study.
• \. Patients or guardian who are unable to understand and sign informed consent.
• \. Pregnancy
• \. Patients in whom it is felt that a major portion of overall sleep morbidity is not related to bruxism.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Allergan: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Bruxism

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: William Ondo, MD
• Organization: Baylor College of Medicine/Houston Methodist

wondo@houstonmethodist.org

713-363-8390

Study Officials

• William G Ondo, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 25, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 18, 2023
• Results First Posted: May 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)