NCT03254186

Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Tardive dyskinesia (TD) is a disabling, embarrassing and often irreversible iatrogenic movement disorder that can occur in anyone exposed to drugs that block dopamine receptors, including first and second generation antipsychotics and antiemetic agents. There is no way to prevent TD except preventing exposure to the inciting agents and there are no approved symptomatic therapies. Propranolol is an FDA-approved β-blocker with limited data supporting its use as a treatment for TD. The goal of this study is to determine the efficacy of propranolol in the treatment of TD in a double-blind, cross-over prospective manner. If propranolol is found to be an effective therapy, it will fulfill a great need in the treatment of TD with a medication that is known to be safe and inexpensive.

Detailed description

Tardive dyskinesia (TD) is a disabling, embarrassing and often irreversible iatrogenic movement disorder that can occur in anyone exposed to drugs that block dopamine receptors, including first and second generation antipsychotics and antiemetic agents. There is no way to prevent TD except preventing exposure to the inciting agents and there are no approved symptomatic therapies. Propranolol is an FDA-approved β-blocker with limited data supporting its use as a treatment for TD. The goal of this study is to determine the efficacy of propranolol in the treatment of TD in a double-blind, cross-over prospective manner. Patients with a diagnosis of TD will be randomized to propranolol or identical placebo. The patients will be treated for eight weeks, complete a one week washout and then crossed over for another eight weeks. Hence, the subjects will be their own controls. Participation in this pilot trial will provide placebo controlled blinded data that will assist in planning a larger phase II trial. If propranolol is found to be an effective therapy, it will fulfill a great need in the treatment of TD with a medication that is known to be safe and inexpensive.

Conditions

• Tardive Dyskinesia

Interventions

Type	Name	Description
DRUG	Propranolol Hydrochloride	Propranolol is started 10 mg tablet twice per day per oral, two week up-titration to reach a total dose of 20mg per oral four times per day over the first two weeks, then will remain on a stable dose for six weeks.
DRUG	Placebo Oral Tablet	Identical placebo is started one tablet twice per day per oral, increase over the first two weeks to reach one tablet four times per day, then will remain on this dose for six weeks.

Timeline

• Start date: 2017-09-18
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2017-08-18
• Last updated: 2019-02-26

Regulatory

• FDA-regulated drug study