Tardive DyskinesiaPhase 2/3NCT03254186
Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia
A Phase 2/3 study testing Propranolol Hydrochloride in people with Tardive Dyskinesia, run by Emory University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tardive Dyskinesia
- What is being tested?
- Propranolol Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 18 Sep 2017to 1 Feb 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
About this study
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.
Read the 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
- Being tested
- Propranolol Hydrochloride, Placebo Oral Tablet
- Keywords
- Propranolol, Safety, Efficacy, Tardive Dyskinesia treatment
- Medical subject headings
- Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol HydrochlorideDrug
Also called Inderal
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.
Placebo Oral TabletDrug
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol Hydrochloride | Experimental | 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. Receives: Drug: Propranolol Hydrochloride |
| Placebo Oral Tablet | Placebo comparator | Identical placebo. The patients will be treated for eight weeks, complete a one week washout and then crossed over to another arm for eight weeks. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 1, 3 4, 6, 7 (up to 18 weeks)
Secondary outcomes (2)
Change in the Clinical Global Impression of Severity (CGI-S) score.
The CGI provides an overall clinician-determined summary measure that takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function.
The CGI-Severity (CGI-S) asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
This rating is based upon observed and reported symptoms, behavior, and function in the past seven days. As symptoms and behavior can fluctuate over a week; the score should reflect the average severity level across the seven days.
Measured: Visit 1, 3 4, 6 (up to 18 weeks)
Change in the Clinical Global Impression -Improvement (CGI-I) score.
The CGI-Improvement (CGI-I) is similarly simple in its format. Each time the patient is seen after medication has been initiated, the clinician compares the patient's overall clinical condition to the one week period just prior to the initiation of medication use (the so-called baseline visit). The CGI-I score obtained at the baseline (initiation) visit serves as a basis for making this assessment. Only the following one query is rated on a seven-point scale: "Compared to the patient's condition at admission to the project [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment."
Measured: Visit 3 and 6 (up to 18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start18 Sep 2017
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Why it stopped: No participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tardive DyskinesiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Atlanta Clinical and Translational Science Institute
- Responsible party
- Principal investigator, Jaime Hatcher-Martin, Emory University
- Investigators
- Jaime Hatcher-Martin, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254186
- Sponsor's protocol ID
- IRB00096912
- Status last verified
- Feb 2019
- First submitted
- 16 Aug 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia
- ClinicalTrials.gov ID
- NCT03254186
- Acronym / sponsor ID
- IRB00096912
- Conditions
- Tardive Dyskinesia
- Keywords
- Propranolol, Safety, Efficacy, Tardive Dyskinesia treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Atlanta Clinical and Translational Science Institute
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol Hydrochloride | Experimental | Drug: Propranolol HydrochlorideTwo 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 comparator | Drug: Placebo Oral TabletIdentical placebo. The patients will be treated for eight weeks, complete a one week washout and then crossed over to another arm for eight weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- breastfeeding
- pregnant
- unstable psychiatric disease
- history of asthma or COPD
- baseline heart rate less than 60
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propranolol HydrochlorideAlso: InderalPropranolol 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 | Propranolol Hydrochloride |
| Placebo Oral TabletAlso: PlaceboIdentical 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. | Drug | Placebo Oral Tablet |
Primary outcome
Change in the Abnormal Involuntary Movement Scale (AIMS) score.
Time frame: Visit 1, 3 4, 6, 7 (up to 18 weeks)
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.
2 secondary outcomes
Change in the Clinical Global Impression of Severity (CGI-S) score.
Time frame: Visit 1, 3 4, 6 (up to 18 weeks)
Change in the Clinical Global Impression -Improvement (CGI-I) score.
Time frame: Visit 3 and 6 (up to 18 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Hatcher-Martin, MD, PhD principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Propranolol Hydrochloride in people with Tardive Dyskinesia, run by Emory University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Abnormal Involuntary Movement Scale (AIMS) score. (time frame: Visit 1, 3 4, 6, 7 (up to 18 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.