Cleveland, OHNCT06997198Now EnrollingIRB Ready

Tardive Dyskinesia Clinical Trial in Cleveland, OH

Access cutting-edge tardive dyskinesia treatment through this clinical trial at a research site in Cleveland. Study-provided care at no cost to qualified participants.

Sponsored by University Hospitals Cleveland Medical Center

Quick Self-Assessment

See if you qualify for this Cleveland location

Preparing your pre-screening questions…

Expert Care in Cleveland

Access tardive dyskinesia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related tardive dyskinesia treatment provided free

Apply for This Cleveland Location

Check if you qualify for this tardive dyskinesia clinical trial in Cleveland, OH

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Cleveland

    Convenient for OH residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Cleveland site if eligible
  4. 4Begin participation

About This Tardive Dyskinesia Study in Cleveland

The primary goal of this study is to investigate the efficacy of deutetrabenazine treatment of TD in this previously untreated patient population. Compare movement disorder deutetrabenazine treatment response in persons with IDD to response seen in patients without IDD treated with deutetrabenazine in other treatment settings (per literature review). Compare global deutetrabenazine treatment response with validated instruments. In addition, we plan to: * Assess the safety of deutetrabenazine in the treatment of TD in persons with IDD. * Assess change in Activities of Daily Living (ADLs) in persons with IDD and TD treated with deutetrabenazine, utilizing a validated ADL instrument. * Assess change in Quality of Life (QOL) in persons with IDD and TD treated with deutetrabenazine, utilizing a validated QOL instrument. * Assess caregiver burden with a validated caregiver burden instrument. In this study, 25 participants with IDD and TD will undergo Deutetrabenazine treatment for 24 weeks. The participants will be seen for a total of 5 visits: at baseline, and at follow up visits at 3 weeks, 6 weeks, 12 weeks, and 24 weeks. This study does not include a comparison group. Therefore, researchers will compare the response of the study participants to deutetrabenazine treatment with those from a previous reported work that resulted in the FDA approval of this medication. This will be an open-label, Phase 4 study.

Sponsor: University Hospitals Cleveland Medical Center

Who Can Participate

Inclusion Criteria

Diagnosis of IDD (IQ \< 70; social/adaptive dysfunction, onset \< age 22) as per DSM-5
Clinical diagnosis of Tardive Dyskinesia (TD) per DSM-5 for at least 3 months before study inclusion (presence of movement disorder for at least 3 months, in absence of previous formal diagnosis of TD).
Eligible to receive deutetrabenazine, according to current product labeling Stable doses of all psychotropic medications for minimum of three months before study inclusion
Willing to remain on stable doses of all psychotropics for 24 weeks of study. If female of childbearing age, practicing acceptable form of birth control throughout study duration.
Subject able to comply with scheduled visits and assessments
Consent of subject, or legally authorized representative to study protocol. Caregiver Inclusion Criteria:
Able to understand and answer questionnaires
Able to comply with scheduled visits
Ability to be primary Caregiver for 24 weeks of study Participant

Exclusion Criteria

Previous treatment with a VMAT2 inhibitor (tetrabenazine, valbenazine, or deutetrabenazine).
Treatment with any investigational drug in the 30 days prior to study entry.
Currently taking a strong CYP2D6 inhibitor such as fluoxetine, paroxetine, quinidine, bupropion. Current treatment with strong anticholinergic agents, monoamine oxidase inhibitors, metoclopramide, dopamine agonists, L-DOPA, or stimulants within past 30 days, or botulinum toxin within the past 3 months.
Any unstable medical condition in the 60 days prior to study entry.
Pregnant or breast-feeding
Current or recent hepatic impairment
History of neuroleptic malignant syndrome
History of long QTc on electrocardiogram, bundle branch block (BBB), atrioventricular block, serious cardiac arrhythmia, or heart failure. QTc on EKG \> 450 msec (Fredericia formula) on EKG within 3 months prior to study entry.
History of substance abuse or dependence in the 3 months prior to study entry.
Significant risk of suicide or dangerous aggression to others at time of or 3 months prior to study entry.
Inability to take study medications Caregiver Exclusion Criteria:
Unable to complete questionnaires
Unable to comply with scheduled visits
Will not be a primary Caregiver for the 24 weeks of the study

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Cleveland?

Yes, this clinical trial (NCT06997198) has an active research site in Cleveland, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Tardive Dyskinesia Treatment Options in Cleveland, OH

If you're searching for tardive dyskinesia treatment options in Cleveland, OH, this clinical trial (NCT06997198) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Cleveland research site is actively enrolling participants for this clinical trial. You'll receive care from experienced tardive dyskinesia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all tardive dyskinesia clinical trials near you to find additional studies recruiting in your area.

More Tardive Dyskinesia Trials in Cleveland, OH

See all tardive dyskinesia clinical trials recruiting in Cleveland — not just this study.

Browse Tardive Dyskinesia Trials in Cleveland

Browse More Trials by Condition

Ready to Join in Cleveland?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Cleveland, OH