Study Stopped
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Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2017
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2017
CompletedFirst Posted
Study publicly available on registry
August 18, 2017
CompletedStudy Start
First participant enrolled
September 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedFebruary 26, 2019
February 1, 2019
1.4 years
August 16, 2017
February 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Abnormal Involuntary Movement Scale (AIMS) score.
AIMS is a rating scale that scores each individual involuntary movement type at different body locations on a five-point anchored scale. For this study, items 1-7 represent the severity portion (rated 0-4) of the scale and will be used as the primary end point. This measure will be completed at the time of the visit by the enrolling physician. In addition, a standardized video documenting the motor portion of the AIMS will be completed at baseline and eight weeks for both segments of the study. These will be placed in a randomized order and scored using the AIMS severity scale by two blinded raters using consensus measures. A comparison of the change in score from placebo to active by the blinded video raters will be the primary outcome measure.
Visit 1, 3 4, 6, 7 (up to 18 weeks)
Secondary Outcomes (2)
Change in the Clinical Global Impression of Severity (CGI-S) score.
Visit 1, 3 4, 6 (up to 18 weeks)
Change in the Clinical Global Impression -Improvement (CGI-I) score.
Visit 3 and 6 (up to 18 weeks)
Other Outcomes (2)
Change in the Short Form-36 question health survey (SF-36v2) score.
Visit 1, 3 4, 6 (up to 18 weeks)
Change in the Craniocervical Dystonia Questionnaire (CDQ-24) score.
Visit 1, 3 4, 6 (up to 18 weeks)
Study Arms (2)
Propranolol Hydrochloride
EXPERIMENTALTwo 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.
Placebo Oral Tablet
PLACEBO COMPARATORIdentical placebo. The patients will be treated for eight weeks, complete a one week washout and then crossed over to another arm for eight weeks.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaime Hatcher-Martin, MD, PhD
Emory University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asstant Professor
Study Record Dates
First Submitted
August 16, 2017
First Posted
August 18, 2017
Study Start
September 18, 2017
Primary Completion
February 1, 2019
Study Completion
February 1, 2019
Last Updated
February 26, 2019
Record last verified: 2019-02