Clinical Trial: TMJ-1001 Bruxism Run-In/Pivotal Trial

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Pivotal Study of the TMJ NextGeneration(TradeMark) Compared to Occlusal Splint Treatment for Reduction in Nocturnal Bruxism Episodes and Monthly Migraine Episodes in Sub

Brief Summary: The study is an open-label, prospective, multi-center, randomized, two treatment parallel, comparison study of the TMJ NextGeneration(TM) and custom-fit occlusal splint in the reduction of nocturnal bruxism episodes and monthly migraine episodes in subjects diagnosed with sleep bruxism and headaches.

Detailed Summary: The study will be conducted at multiple study centers in the U.S. The study will consist of a screening period lasting up to 5 weeks and a treatment period lasting 8 weeks. Subjects will visit the dental clinic twice during the screening period, at Day 1, and at Weeks 4 and 8 of the study.The study will include a single-center run-in phase during which 12 subjects will be enrolled in order to gain preliminary effectiveness data on the TMJ NextGeneration(TM) device. Following completion of the first 12 subjects, a sample size re-estimation may be conducted in order to verify the initial sample size assumptions of the study. These run-in subjects will not be included in the final analysis of the study. Approximately a total of 153 subjects will be enrolled in the study with subjects allocated 2:1 to the TMJ NextGeneration(TM) and occlusal splint treatment arms, respectively. The study is powered with respect to the dual primary effectiveness endpoints of CFB in bruxism episodes per hour of sleep and CFB in migraine episodes per month.
Sponsor: TMJ Health

Current Primary Outcome:

  • Change from Baseline (CFB) in bruxism episodes per hour of sleep [ Time Frame: Baseline and Week 8 ]
  • CFB in the number of migraine episodes per month [ Time Frame: Baseline and Week 8 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • CFB in the number of headache episodes per month [ Time Frame: Baseline and Week 8 ]
  • CFB in the in-clinic pain Visual Analogue Scale (VAS) scores [ Time Frame: Baseline and Week 8 ]
  • CFB in the average daily at-home pain VAS scores [ Time Frame: Baseline and Week 8 ]
  • CFB in the morning daily at-home pain VAS scores [ Time Frame: Baseline and Week 8 ]
  • CFB in the evening daily at-home pain VAS scores [ Time Frame: Baseline and Week 8 ]


Original Secondary Outcome: Same as current

Information By: Cardiox Corporation

Dates:
Date Received: October 7, 2014
Date Started: April 2015
Date Completion: December 2015
Last Updated: May 12, 2015
Last Verified: May 2015