Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia

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Brief Title

Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia

Official Title

Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia

Brief 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.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Change in the Abnormal Involuntary Movement Scale (AIMS) score.

Secondary Outcome

 Change in the Clinical Global Impression of Severity (CGI-S) score.

Condition

Tardive Dyskinesia

Intervention

Propranolol Hydrochloride

Study Arms / Comparison Groups

 Propranolol Hydrochloride
Description:  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. The patients will be treated for eight weeks, complete a one week washout and then crossed over to another arm for eight weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

September 18, 2017

Completion Date

February 1, 2019

Primary Completion Date

February 1, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  age 18-75 years

          -  diagnosis of classical TD by a movement disorder expert for at least 6 months with a
             baseline score of at least 2 on two of the seven items on the AIMS severity scale

          -  stable on medication (either on or off dopamine blocking agents) for at least six
             months.

        Exclusion Criteria:

          -  breastfeeding

          -  pregnant

          -  unstable psychiatric disease

          -  history of asthma or COPD

          -  baseline heart rate less than 60

          -  history of orthostatic hypertension or its presence at screening

          -  history of congestive heart failure or unstable angina pectoris

          -  resting SBP <100 and DBP < 60

          -  AV-block II or III without pacemaker

          -  history of diabetes mellitus

          -  previous adverse effects from use of beta-blockers

          -  current use of a β-blocker and the other following drugs: quinidine, amiodarone,
             propafenone, digoxin, verapamil, diltiazem, clonidine, and warfarin

          -  tremor, dystonia, akathisia or other non-tardive movement disorder

          -  any medical illness that precludes treatment with propranolol.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Jaime Hatcher-Martin, MD, PhD, , 



Administrative Informations


NCT ID

NCT03254186

Organization ID

IRB00096912


Responsible Party

Principal Investigator

Study Sponsor

Emory University

Collaborators

 Atlanta Clinical and Translational Science Institute

Study Sponsor

Jaime Hatcher-Martin, MD, PhD, Principal Investigator, Emory University


Verification Date

February 2019