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Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia

NCT03254186 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2019-02-26

No results posted yet for this study

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.

Conditions

  • Tardive Dyskinesia

Interventions

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.

Sponsors & Collaborators

  • Atlanta Clinical and Translational Science Institute

    collaborator OTHER

  • Emory University

    lead OTHER

Principal Investigators

  • Jaime Hatcher-Martin, MD, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2019-02-01
Completion
2019-02-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03254186 on ClinicalTrials.gov