Study of Orofacial Pain and PropRANOlol

• Status: Completed
• Trial end date: 2018-04-25
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Propranolol

Criteria

Inclusion:

• Diagnostic criteria for TMD: Group II, Masticatory Muscle Disorders, Myalgia

• Facial pain for at least 3 months (and at least 10 of the last 30 days at Visit 0)

• Average pain intensity rating ≥30 (0-100 numeric rating scale) over the past week or average daily pain intensity rating ≥30 on the same scale on at least 3 days over the past week

• Agrees to terms for continuing/discontinuing certain prescription/over-the-counter pain medications throughout participation

• Agrees to not commence new prescription medication, injection therapy, occlusal splint therapy or certain other pain management techniques throughout participation

• Agrees to limit consumption of alcohol to no more than 7 drinks/week (females) and no more than 14 drinks/week (males) throughout participation

• If a female of childbearing potential, agrees to use of contraception (licensed hormonal method, intrauterine device, condoms with contraceptive foam, abstinence, or partner vasectomy) throughout participation

• Able to understand and comply with study procedures and provide written informed consent

Exclusion:

• History of congestive heart failure or certain cardiac conditions including coronary artery disease, uncontrolled hypertension, or hypotension

• Bronchial asthma, nonallergic bronchospasm, renal failure or dialysis, diabetes mellitus, hyperthyroidism, fibromyalgia, or uncontrolled seizures

• Currently taking a β-blocker or certain other medications including haloperidol, intravenous verapamil, or reserpine

• Currently taking an opioid medication

• Daily prescription medication, occlusal splint therapy, or an investigational drug or treatment for pain management within past 30 days

• Injection therapy or certain other pain management techniques within last 2 weeks

• Facial trauma or orofacial surgery within past 6 weeks

• Active orthodontic treatment

• History of major depression or other psychiatric disorder requiring hospitalization within past 6 months

• Treatment for drug or alcohol abuse within the last year

• Smokes 25 or more cigarettes/day

• Currently receiving chemotherapy or radiation therapy

• Pregnant or breastfeeding