Purpose:
Primary: To evaluate the efficacy of extended-release (ER) propranolol compared to placebo in
the reduction of a pain index in patients with temporomandibular disorder (TMD).
Secondary: To determine if extended-release propranolol efficacy varies according to
participants' catechol-O-methyltransferase (COMT) genetic polymorphisms and to investigate
the efficacy of extended-release propranolol compared with placebo using secondary endpoints.
Exploratory: To investigate whether the efficacy of extended-release propranolol in the
reduction of the pain index varies according to participants' polymorphisms in 3 other
genetic regions and according to various phenotypic characteristics.
Participants:
200 patients with chronic TMD will be randomly assigned, in a 1:1 parallel, double-blind
fashion, to receive either extended-release propranolol or placebo at one of three study
sites: University of North Carolina-Chapel Hill School of Dentistry; University of
Florida-Gainesville College of Dentistry; and the State University of New York at Buffalo
School of Dental Medicine.
Procedures (methods):
Randomization will be to either propranolol or placebo. The 10-week study treatment period is
divided into: 1 week of drug titration, 8 weeks of drug maintenance, and 1 week of drug
tapering. The titration and tapering doses are 60 mg (capsules) once per day orally; the
maintenance dose is 60 mg twice per day orally. Participants will attend 6 clinic visits over
12-15 weeks as follows: screening and baseline visit (Visit [V] 0, 7-21 days prior to V1);
randomization and start of treatment (titration) (V1, study day 0); maintenance visit 2 (V2,
1 week post-randomization, study day 7+3); maintenance visit 3 (V3, 5 weeks
post-randomization, study day 35 +/- 7); tapering visit (V4, 9 weeks post-randomization,
study day 63 +/- 7); and tapering visit 5 (V5, 11 weeks post-randomization and 1 week after
drug tapering ends, study day 77 +/- 7). Depending on the visit, procedures will include:
reviews of medical history, weekly alcohol consumption, concomitant therapies and
medications, adverse events, compliance, and eligibility; administration/review of
questionnaires; blood draw; pregnancy test in women of childbearing potential; and dispensing
of study drug.
Phase:
Phase 2
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
National Institute of Dental and Craniofacial Research (NIDCR) National Institutes of Health (NIH) Rho, Inc. State University of New York at Buffalo University of Florida