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