Trial Outcomes & Findings for Study of the Safety and Efficacy of Botox in Bruxism (NCT NCT00908050)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

baseline versus week 4

Results posted on

2023-06-18

Participant Flow

Thirty-one subjects were recruited but eight were excluded: 3 prior to randomization/PSG (withdrew consent), 5 before randomization/after PSG (3 for lack of bruxism on PSG, 2 for severe obstructive sleep apnea on PSG with an AHI \> 30 / hr).

Participant milestones

Participant milestones
Measure	Placebo Placebo arm	Botulinum Toxin Type A botulinum toxin type A (BOTOX)
Overall Study STARTED	10	13
Overall Study COMPLETED	10	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Safety and Efficacy of Botox in Bruxism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=10 Participants Placebo arm We performed a double blind, placebo-controlled parallel trial of BoNT-A (Botox®, Allergan) for bruxism, followed by an open label extension. Patients were recruited from the Baylor College of Medicine (BCM) Movement Disorders Clinic from April 2009 to March 2011.	Botulinum Toxin Type A n=13 Participants Active arm We performed a double blind, placebo-controlled parallel trial of BoNT-A (Botox®, Allergan) for bruxism, followed by an open label extension. Patients were recruited from the Baylor College of Medicine (BCM) Movement Disorders Clinic from April 2009 to March 2011.	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	13 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline versus week 4

Population: Bruxism questionnaire comparison at Week 4 in placebo versus active treatment group.

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.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo arm at baseline Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].	Botulinum Toxin Type A at Baseline n=13 Participants Active arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].	Placebo Arm at Week 4 n=10 Participants Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].	Botulinum Toxin Type A at Week 4 n=13 Participants Active arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].
Bruxism Questionnaire Baseline and at Week 4	19.4 units on a scale Standard Deviation 13.2	16.1 units on a scale Standard Deviation 4.1	24.0 units on a scale Standard Deviation 5.4	24.0 units on a scale Standard Deviation 6.9

SECONDARY outcome

Timeframe: Baseline to week 4

Population: HIT-6 questionnaire comparison at Week 4 in placebo versus active treatment group.

Baseline assessments included HIT-6 questionnaire. This is compared to week 4 assessments. The Headache Impact Test consists of 6 questions. Each question can be scored between 6 to 13 points for a possible total of 78 points. A total score of 50 or more means the patient has migraines. A score of 49 or less means the patient has headaches, not migraines. The minimum score if 36. The maximum score is 78 points.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo arm at baseline Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].	Botulinum Toxin Type A at Baseline n=13 Participants Active arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].	Placebo Arm at Week 4 n=10 Participants Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].	Botulinum Toxin Type A at Week 4 n=13 Participants Active arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].
Headache Impact Test (HIT-6) Questionnaire Baseline and at Week 4	57.8 units on a scale Standard Deviation 9.0	52.1 units on a scale Standard Deviation 10.6	59.2 units on a scale Standard Deviation 9.1	51.2 units on a scale Standard Deviation 11.4

SECONDARY outcome

Timeframe: baseline versus week 4

Population: CGI questionnaire comparison at Week 4 in placebo versus active treatment group.

With this scale the clinical evaluates the patient and gives the patient a single score based off of the evaluation. The score given can be between 1 and 7 where 1 means the patient is normal and 7 means the patient is amongst the most severely ill. The minimum score if 1. The maximum score is 7.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo arm at baseline Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].	Botulinum Toxin Type A at Baseline n=13 Participants Active arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].	Placebo Arm at Week 4 n=10 Participants Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].	Botulinum Toxin Type A at Week 4 n=13 Participants Active arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].
Clinical Global Impression (CGI)	3 units on a scale Standard Deviation 0.05	4 units on a scale Standard Deviation 0.05	3 units on a scale Standard Deviation 0.05	2 units on a scale Standard Deviation 0.05

SECONDARY outcome

Timeframe: baseline versus week 4

Population: VAS-pain scale questionnaire comparison at Week 4 in placebo versus active treatment group.

Visual Analog scale of change (VAS) (0-100) comparing delta of pre-versus post-injection.The VAS allows the patient to report their current level of pain on a scale of 0-100 where a score of 0-4 means no pain, a score of 5-44 means mild pain, a score of 45-74 means moderate pain and a score of 75-100 means severe pain. The minimum score is 0 and the maximum score if 100.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo arm at baseline Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].	Botulinum Toxin Type A at Baseline n=13 Participants Active arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].	Placebo Arm at Week 4 n=10 Participants Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].	Botulinum Toxin Type A at Week 4 n=13 Participants Active arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].
Visual Analog Scale of Change (VAS)-Pain Scale	47.3 units on a scale Standard Deviation 15.5	64.5 units on a scale Standard Deviation 17.8	45.8 units on a scale Standard Deviation 19.6	48.6 units on a scale Standard Deviation 13.6

SECONDARY outcome

Timeframe: Baseline versus week 4

Population: VAS-pain questionnaire comparison at Week 4 in placebo versus active treatment group.

The VAS allows the patient to report their current level of pain on a scale of 0-100 where a score of 0-4 means no pain, a score of 5-44 means mild pain, a score of 45-74 means moderate pain and a score of 75-100 means severe pain. The minimum score is 0 and the maximum sore if 100.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo arm at baseline Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].	Botulinum Toxin Type A at Baseline n=13 Participants Active arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].	Placebo Arm at Week 4 n=10 Participants Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].	Botulinum Toxin Type A at Week 4 n=13 Participants Active arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\].
Visual Analog Scale of Change (VAS)-Pain	47.3 units on a scale Standard Deviation 15.5	44.2 units on a scale Standard Deviation 14.3	48.6 units on a scale Standard Deviation 13.6	65 units on a scale Standard Deviation 19.6

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Botulinum Toxin Type A

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=10 participants at risk Placebo arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\]. Additional scales included the Headache Impact Test-6 24, total Pittsburgh Sleep Quality Index 25, Epworth Sleepiness Scale 26, and Self-Rated Anxiety Scale. 27 Subjects then underwent a baseline polysomnogram (PSG) and were excluded if no bruxism was identified, using standard criteria.	Botulinum Toxin Type A n=13 participants at risk Active arm Baseline assessments included a bruxism questionnaire with a modified quantifiable portion \[Lavigne G. with permission\]. Additional scales included the Headache Impact Test-6 24, total Pittsburgh Sleep Quality Index 25, Epworth Sleepiness Scale 26, and Self-Rated Anxiety Scale. 27 Subjects then underwent a baseline polysomnogram (PSG) and were excluded if no bruxism was identified, using standard criteria.
General disorders temporal-mandibular pain	80.0% 8/10 • Number of events 8	100.0% 13/13 • Number of events 13
General disorders cosmetic change in smile	0.00% 0/10	15.4% 2/13 • Number of events 2

Additional Information

William Ondo, MD

Baylor College of Medicine/Houston Methodist

Phone: 713-363-8390

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place