Tardive DyskinesiaPhase 4TD-AIDDNCT06107829
Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities
A Phase 4 study testing Valbenazine Oral Capsule in people with Tardive Dyskinesia and Intellectual Disability, run by Stephen Ruedrich at 1 site in United States.
Trial summary
The goal of this open-label clinical trial is to test the safety and efficacy of valbenazine treatment in patients with Intellectual/Developmental Disability (IDD) who have a diagnosis of Tardive dyskinesia (TD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tardive Dyskinesia, Intellectual Disability, Developmental Disabilities
- What is being tested?
- Valbenazine Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2025to Feb 2027
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 valbenazine 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 for birth control throughout study duration.
- Subject able to comply with scheduled visits and assessments.
- Consent of subject, or legally authorized representative to study protocol.
Who cannot join
- 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 CYP3A4 inducer such as carbamazepine, phenobarbital, diphenylhydantoin, or primidone.
- Any unstable medical condition in the 60 days prior to study entry.
- Pregnant or breast-feeding.
- Inability to take study medication.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland
Cleveland, Ohio, 44106
About this study
Official title: Identification, Assessment, and Treatment of Tardive Dyskinesia With Valbenazine in Adults With Intellectual/Developmental Disabilities and Co-occurring Psychiatric and/or Behavioral Disorders
The goal of this open-label clinical trial is to test the safety and efficacy of valbenazine treatment in patients with Intellectual/Developmental Disability (IDD) who have a diagnosis of Tardive dyskinesia (TD). The main questions this study aims to answer are:
- Does valbenazine treatment of TD in the previously untreated patient population of adults with IDD produce comparable amelioration of signs of movement disorder as what has historically been reported in adults without IDD?
- Is valbenazine treatment of TD in persons with IDD as safe as what has historically been reported in adults without IDD?
- Does valbenazine treatment improve Quality of Life (QOL) in persons with IDD and TD treated with valbenazine?
- Does valbenazine treatment produce positive change in Activities of Daily Living (ADLs) in persons with IDD and TD?
- Does valbenazine treatment of TD in persons with IDD reduce caregiver burden?
Read more
In this study, 25 participants with IDD and TD will undergo valbenazine 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 valbenazine treatment with those from a previous reported work that resulted in the FDA approval of this medication.
Read the detailed description
Tardive dyskinesia (TD) is recognized as a common and often debilitating movement disorder, associated with treatment of a variety of illnesses with dopamine receptor-blocking medications (also commonly known as antipsychotic medications. In addition to the distressing and disfiguring movements of TD, there is now also evidence of a reduced quality of life in patients with TD compared to peers with similar psychiatric disorders without TD.
When originally described, TD had been thought to be primarily associated with use of First-Generation Antipsychotics (FGA's, also known as typical antipsychotics), but there are now good studies to suggest that TD is also frequently a result of exposure to Second Generation Antipsychotics (SGA's) as well. Valbenazine, a selective vesicular monoamine transporter 2 inhibitor, is now available to treat the symptoms of TD, with a favorable efficacy and safety profile. This medication offers, for the first time, a treatment option for patients - as well as their caregivers and families - suffering with TD.
Individuals with intellectual and developmental disabilities (IDD) commonly suffer from co-occurring psychiatric and/or behavioral disorders (informally known as a "dual diagnosis"). Such individuals are commonly prescribed antipsychotic medications to treat these co-occurring disorders. Several authors have noted that antipsychotic medications have frequently been over-prescribed for individuals with IDD, often in the absence of an identified psychotic illness. Some studies have shown that up to 20-30% of adults with IDD are prescribed antipsychotic medications across a variety of residential settings.
Surrounding this frequent use of antipsychotic medications in persons with IDD, it is now well-established that persons and that having intellectual disability is a recognized risk factor for developing TD when treated with antipsychotic medications. Finally, recent research has confirmed the long-suspected belief that persons with IDD are MORE susceptible to movement disorder side effects when treated with antipsychotic medications when compared to persons without IDD.
Based on their increased exposure to antipsychotics, and increased susceptibility to movement disorders including TD, it would seem that persons with IDD who have TD are a group who could benefit most from treatment with a novel agent which can address this movement disorder.
Before TD can be treated, it must be clinically identified and formally diagnosed. Once diagnosed, patients and families must be educated on the availability of treatment options, outcomes when no treatment is undertaken, and the potential benefits (and risks) of treatment itself.
Movement disorders such as TD have been diagnosed on the basis of clinical examination, often using formal assessment tools to identify and quantify the movement abnormalities seen. One such instrument is the Abnormal Involuntary Movement Scale (AIMS). The AIMS has been used for many years as the gold standard for this purpose. In addition, there have been recent attempts to quantify the amount of improvement (change in movement intensity, and reduction in AIMS scores) that are considered clinically significant in rating improvement. Additionally, a number of authors have noted the difficulty in using the AIMS in persons with IDD who cannot cooperate fully in the examination process. For this reason, some have suggested using videotaped AIMS exams as a methodology for more accurately quantifying change. Videotaping of exams pre- and post-treatment for blind rating of improvement has been a methodology utilized in a number of recent studies of valbenazine.
In this study, 25 participants with IDD and TD will undergo valbenazine 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. Consented participants will have an AIMS administered and videotaped at each visit, initially to identify and quantify TD, and subsequently to measure possible response to valbenazine. Subjects' TD response to valbenazine will also be assessed using the Clinical Global Impression of Change (CGI-C) scale (by investigator) and Caregiver Global Impression Scale (by proxy caregiver). Subjects' quality of life will be assessed with the World Health Organization Quality of Life Scale- For Persons with Disability (WHOQOL-DIS), a proxy-reported instrument designed for individuals with IDD, before and after valbenazine treatment. Participants' behavior will be assessed with the Aberrant Behavior Checklist-Irritability Subscale, before and after valbenazine treatment. Subjects' Activities of Daily Living (ADL's) will be assessed with the Waisman Activities of Daily Living Scale (W-ADL), a proxy-reported instrument designed for individuals with IDD and other disabilities, before and after valbenazine treatment. Caregiver burden will be assessed with the Zarit Burden Inventory, short version, before and after valbenazine treatment.
- Being tested
- Valbenazine Oral Capsule
- Keywords
- valbenazine, movement disorders, antipsychotic medication adverse effects, Abnormal Involuntary Movement Scale, quality of life, adaptive behavior, caregiver burden, selective vesicular monoamine transporter 2 inhibitor
- Medical subject headings
- Tardive Dyskinesia, Intellectual Disability, Developmental Disabilities, Movement Disorders, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valbenazine Oral CapsuleDrug
Also called Ingrezza
Open-label twenty-four-week treatment with valbenazine oral capsules (up to 80 mg/day) to test the safety and effectiveness of this medication in ameliorating the signs of tardive dyskinesia in persons with intellectual disability.
| Study group | Role | What they receive |
|---|---|---|
| Valbenazine | Experimental | This an open-label study in which all participants will have their valbenazine dose titrated from 40 mg to 80 mg per day, which will remain the valbenazine dose through end of study, unless interrupted by adverse events. Participants taking valbenazine who are concurrently taking strong CYP2D6 inhibitors (paroxetine, fluoxetine, bupropion, duloxetine) will continue their valbenazine dose at 40 mg per day through end of study. Participants taking valbenazine who are concurrently taking strong CYP3A4 inhibitors (ketoconazole, fluconazole, cimetidine, verapamil) will continue their valbenazine dose at 40 mg per day through end of study. Receives: Drug: Valbenazine Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AIMS total scores of items 1-7
The Abnormal Involuntary Movement Scale (AIMS) has been used for many years as the gold standard for this purpose and the amount of improvement (change in movement intensity, and reduction in AIMS scores) have been assessed clinical significance in rating improvement. A number of authors have noted the difficulty in using the AIMS in persons with IDD who cannot cooperate fully in the examination process. For this reason, some have suggested using videotaped AIMS exams as a methodology for more accurately quantifying change. Videotaping of exams pre- and post-treatment for blind rating of improvement has been a methodology utilized in a number of recent studies of valbenazine. The minimum value of the AIMS total score of items 1-7 is 0 and the maximum value is 49. Higher total AIMS scores mean worse outcomes.
Measured: Baseline and 24 weeks from start of treatment
Secondary outcomes (6)
Change in AIMS item 8 scores
Item 8 of the AIMS represents an overall index of severity of abnormal involuntary movements. The minimum value of the AIMS total score of items 1-7 is 0 and the maximum value is 4; Higher total scores mean worse outcomes.
Measured: Baseline and 24 weeks from start of treatment
CGI-C
Clinical Global Impression of Change (CGI-C), as the names indicates, denotes the clinician's impression of change between baseline and after the treatment in which -3 will be marked worsening, -2 moderate worsening, -1 mild worsening, 0 no change, +1 will be marked for mild improvement, +2 moderate improvement, and +3 marked improvement.
Measured: Baseline and 24 weeks from start of treatment
CaGI-C
Caregiver Global Impression of Change (CaGI-C). This is similar to the CGI-C, except that this is the impression of the participant's caregiver, -3 will be marked worsening, -2 moderate worsening, -1 mild worsening, 0 no change, +1 will be marked for mild improvement, +2 moderate improvement, and +3 marked improvement.
Measured: Baseline and 24 weeks from start of treatment
Change in ABC-I score
The Aberrant Behavioral Checklist, Irritability Subscale (ABC-I) is commonly used in clinical trials. It consists of 15 items, which are scored on a 4-point Likert scale of severity, ranging from "not at all a problem" to "the problem is severe in degree."
Measured: Baseline and 24 weeks from start of treatment
Change in W-ADL score
The Waisman Activities of Daily Living (W-ADL) Scale for adolescents and adults with developmental disabilities, is a validated scale that consists of 17 items in the final version of the W-ADL pertain to the current or expected performance of the target individual at the time when the survey was given. The target adult's performance of each activity is rated on a 3-point scale (0 = "does not do at all", 1 = "does with help", 2 = "independent"), and item scores are summed to produce an overall score. Therefore, this means that the scores can range from a minimum of 0 to a maximum value of 51. Higher total W-ADL scores mean better outcomes.
Measured: Baseline and 24 weeks from start of treatment
Change in Zarit Burden Interview (short version) score
The short version of the Zarit Burden Interview is suitable across diagnostic groups of cognitively impaired older adults, and can be used in cross-sectional, longitudinal, and intervention studies. It consists of 12 items, which are answered by a caregiver and measures the change over time, resulting from the progression of (or therapeutic effect of an intervention on) the care recipient's condition. Each item is scored on a 5-point Likert scale, with higher scores indicating greater burden, i.e., worse outcome.
Measured: Baseline and 24 weeks from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study startJan 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Why it stopped: Not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Tardive DyskinesiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen Ruedrich
- Sponsor type
- University, hospital or other
- Collaborators
- Neurocrine Biosciences
- Responsible party
- Sponsor-investigator, Stephen Ruedrich, University Hospitals Cleveland Medical Center
- Investigators
- Stephen Ruedrich, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107829
- Sponsor's protocol ID
- STUDY20221555
- Acronym
- TD-AIDD
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2023
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Trial data can be made available on reasonable request to the principal investigator and must be accompanied by detailed study proposals, a description of study objectives, and a statistical analysis plan. Access to available deidentified participant data and the trial protocol may be granted 12 months after publication.
Publications
Aman MG (2012) Aberrant Behavior Checklist: Current Identity and Future Developments. Clin Exp Pharmacol 2:e114. doi:10.4172/2161- 1459.1000e114
Barnes TR. The Barnes Akathisia Rating Scale--revisited. J Psychopharmacol. 2003 Dec;17(4):365-70. doi: 10.1177/0269881103174013.
PubMed 14870947Bowring DL, Totsika V, Hastings RP, Toogood S, McMahon M. Prevalence of psychotropic medication use and association with challenging behaviour in adults with an intellectual disability. A total population study. J Intellect Disabil Res. 2017 Jun;61(6):604-617. doi: 10.1111/jir.12359. Epub 2017 Jan 16.
PubMed 28090687Correll CU, Kane JM, Citrome LL. Epidemiology, Prevention, and Assessment of Tardive Dyskinesia and Advances in Treatment. J Clin Psychiatry. 2017 Sep/Oct;78(8):1136-1147. doi: 10.4088/JCP.tv17016ah4c.
PubMed 29022654de Kuijper GM, Hoekstra PJ. Physicians' reasons not to discontinue long-term used off-label antipsychotic drugs in people with intellectual disability. J Intellect Disabil Res. 2017 Oct;61(10):899-908. doi: 10.1111/jir.12385. Epub 2017 May 30.
PubMed 28560761de Kuijper GM, Hoekstra PJ. Assessment of Drug-Associated Extrapyramidal Symptoms in People With Intellectual Disability: A Comparison of an Informant-Based Scale With Clinical Rating Scales. J Clin Psychopharmacol. 2016 Oct;36(5):508-12. doi: 10.1097/JCP.0000000000000558.
PubMed 27529770Fodstad JC, Bamburg JW, Matson JL, Mahan S, Hess JA, Neal D, Holloway J. Tardive dyskinesia and intellectual disability: an examination of demographics and topography in adults with dual diagnosis and atypical antipsychotic use. Res Dev Disabil. 2010 May-Jun;31(3):750-9. doi: 10.1016/j.ridd.2010.01.017. Epub 2010 Mar 5.
PubMed 20207106Guy W (1976). ECDEU Assessment Manual for Psychopharmacology: Revised (DHEW publication number ADM 76-338). Rockville, MD, Us Department of Health, Education and Welfare, PHS, ADAMHA, NIMH Psychopharmacology Research Branch, Division of Extramural Research Programs, 1976:534-537.
Hauser RA, Factor SA, Marder SR, Knesevich MA, Ramirez PM, Jimenez R, Burke J, Liang GS, O'Brien CF. KINECT 3: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Valbenazine for Tardive Dyskinesia. Am J Psychiatry. 2017 May 1;174(5):476-484. doi: 10.1176/appi.ajp.2017.16091037. Epub 2017 Mar 21.
PubMed 28320223Hérbert, R., Bravo, G., & Préville, M. (2000). Reliability, validity, and reference values of the Zarit Burden Interview for assessing informal caregivers of community-dwelling older persons with dementia. Canadian Journal on Aging, 19, 494-507.
Kane JM, Correll CU, Nierenberg AA, Caroff SN, Sajatovic M; Tardive Dyskinesia Assessment Working Group. Revisiting the Abnormal Involuntary Movement Scale: Proceedings From the Tardive Dyskinesia Assessment Workshop. J Clin Psychiatry. 2018 May/Jun;79(3):17cs11959. doi: 10.4088/JCP.17cs11959.
PubMed 29742330Maenner MJ, Smith LE, Hong J, Makuch R, Greenberg JS, Mailick MR. Evaluation of an activities of daily living scale for adolescents and adults with developmental disabilities. Disabil Health J. 2013 Jan;6(1):8-17. doi: 10.1016/j.dhjo.2012.08.005. Epub 2012 Oct 17.
PubMed 23260606Matson JL, Fodstad JC, Neal D, Dempsey T, Rivet TT. Risk factors for tardive dyskinesia in adults with intellectual disability, comorbid psychopathology, and long-term psychotropic use. Res Dev Disabil. 2010 Jan-Feb;31(1):108-16. doi: 10.1016/j.ridd.2009.08.002. Epub 2009 Aug 31.
PubMed 19720497McEvoy J, Gandhi SK, Rizio AA, Maher S, Kosinski M, Bjorner JB, Carroll B. Effect of tardive dyskinesia on quality of life in patients with bipolar disorder, major depressive disorder, and schizophrenia. Qual Life Res. 2019 Dec;28(12):3303-3312. doi: 10.1007/s11136-019-02269-8. Epub 2019 Aug 21.
PubMed 31435866Morton RO, Morton LC, Fedora R. Recognition and Treatment of Tardive Dyskinesia in Individuals with Intellectual Disability. Case Rep Psychiatry. 2020 Dec 11;2020:8886980. doi: 10.1155/2020/8886980. eCollection 2020.
PubMed 33414976
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification, Assessment, and Treatment of Tardive Dyskinesia With Valbenazine in Adults With Intellectual/Developmental Disabilities and Co-occurring Psychiatric and/or Behavioral Disorders
- ClinicalTrials.gov ID
- NCT06107829
- Acronym / sponsor ID
- TD-AIDD / STUDY20221555
- Keywords
- valbenazine, movement disorders, antipsychotic medication adverse effects, Abnormal Involuntary Movement Scale, quality of life, adaptive behavior, caregiver burden, selective vesicular monoamine transporter 2 inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stephen RuedrichUniversity, hospital or other
- Collaborators
- Neurocrine Biosciences
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 30 Oct 2023 (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.
The goal of this open-label clinical trial is to test the safety and efficacy of valbenazine treatment in patients with Intellectual/Developmental Disability (IDD) who have a diagnosis of Tardive dyskinesia (TD). The main questions this study aims to answer are:
- Does valbenazine treatment of TD in the previously untreated patient population of adults with IDD produce comparable amelioration of signs of movement disorder as what has historically been reported in adults without IDD?
- Is valbenazine treatment of TD in persons with IDD as safe as what has historically been reported in adults without IDD?
- Does valbenazine treatment improve Quality of Life (QOL) in persons with IDD and TD treated with valbenazine?
- Does valbenazine treatment produce positive change in Activities of Daily Living (ADLs) in persons with IDD and TD?
- Does valbenazine treatment of TD in persons with IDD reduce caregiver burden?
In this study, 25 participants with IDD and TD will undergo valbenazine 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 valbenazine treatment with those from a previous reported work that resulted in the FDA approval of this medication.
Detailed description
Tardive dyskinesia (TD) is recognized as a common and often debilitating movement disorder, associated with treatment of a variety of illnesses with dopamine receptor-blocking medications (also commonly known as antipsychotic medications. In addition to the distressing and disfiguring movements of TD, there is now also evidence of a reduced quality of life in patients with TD compared to peers with similar psychiatric disorders without TD.
When originally described, TD had been thought to be primarily associated with use of First-Generation Antipsychotics (FGA's, also known as typical antipsychotics), but there are now good studies to suggest that TD is also frequently a result of exposure to Second Generation Antipsychotics (SGA's) as well. Valbenazine, a selective vesicular monoamine transporter 2 inhibitor, is now available to treat the symptoms of TD, with a favorable efficacy and safety profile. This medication offers, for the first time, a treatment option for patients - as well as their caregivers and families - suffering with TD.
Individuals with intellectual and developmental disabilities (IDD) commonly suffer from co-occurring psychiatric and/or behavioral disorders (informally known as a "dual diagnosis"). Such individuals are commonly prescribed antipsychotic medications to treat these co-occurring disorders. Several authors have noted that antipsychotic medications have frequently been over-prescribed for individuals with IDD, often in the absence of an identified psychotic illness. Some studies have shown that up to 20-30% of adults with IDD are prescribed antipsychotic medications across a variety of residential settings.
Surrounding this frequent use of antipsychotic medications in persons with IDD, it is now well-established that persons and that having intellectual disability is a recognized risk factor for developing TD when treated with antipsychotic medications. Finally, recent research has confirmed the long-suspected belief that persons with IDD are MORE susceptible to movement disorder side effects when treated with antipsychotic medications when compared to persons without IDD.
Based on their increased exposure to antipsychotics, and increased susceptibility to movement disorders including TD, it would seem that persons with IDD who have TD are a group who could benefit most from treatment with a novel agent which can address this movement disorder.
Before TD can be treated, it must be clinically identified and formally diagnosed. Once diagnosed, patients and families must be educated on the availability of treatment options, outcomes when no treatment is undertaken, and the potential benefits (and risks) of treatment itself.
Movement disorders such as TD have been diagnosed on the basis of clinical examination, often using formal assessment tools to identify and quantify the movement abnormalities seen. One such instrument is the Abnormal Involuntary Movement Scale (AIMS). The AIMS has been used for many years as the gold standard for this purpose. In addition, there have been recent attempts to quantify the amount of improvement (change in movement intensity, and reduction in AIMS scores) that are considered clinically significant in rating improvement. Additionally, a number of authors have noted the difficulty in using the AIMS in persons with IDD who cannot cooperate fully in the examination process. For this reason, some have suggested using videotaped AIMS exams as a methodology for more accurately quantifying change. Videotaping of exams pre- and post-treatment for blind rating of improvement has been a methodology utilized in a number of recent studies of valbenazine.
In this study, 25 participants with IDD and TD will undergo valbenazine 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. Consented participants will have an AIMS administered and videotaped at each visit, initially to identify and quantify TD, and subsequently to measure possible response to valbenazine. Subjects' TD response to valbenazine will also be assessed using the Clinical Global Impression of Change (CGI-C) scale (by investigator) and Caregiver Global Impression Scale (by proxy caregiver). Subjects' quality of life will be assessed with the World Health Organization Quality of Life Scale- For Persons with Disability (WHOQOL-DIS), a proxy-reported instrument designed for individuals with IDD, before and after valbenazine treatment. Participants' behavior will be assessed with the Aberrant Behavior Checklist-Irritability Subscale, before and after valbenazine treatment. Subjects' Activities of Daily Living (ADL's) will be assessed with the Waisman Activities of Daily Living Scale (W-ADL), a proxy-reported instrument designed for individuals with IDD and other disabilities, before and after valbenazine treatment. Caregiver burden will be assessed with the Zarit Burden Inventory, short version, before and after valbenazine treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valbenazine | Experimental | Drug: Valbenazine Oral CapsuleThis an open-label study in which all participants will have their valbenazine dose titrated from 40 mg to 80 mg per day, which will remain the valbenazine dose through end of study, unless interrupted by adverse events. Participants taking valbenazine who are concurrently taking strong CYP2D6 inhibitors (paroxetine, fluoxetine, bupropion, duloxetine) will continue their valbenazine dose at 40 mg per day through end of study. Participants taking valbenazine who are concurrently taking strong CYP3A4 inhibitors (ketoconazole, fluconazole, cimetidine, verapamil) will continue their valbenazine dose at 40 mg per day through end of study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 valbenazine 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 for birth control throughout study duration.
Key exclusion criteria (11 listed)
- 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 CYP3A4 inducer such as carbamazepine, phenobarbital, diphenylhydantoin, or primidone.
- Any unstable medical condition in the 60 days prior to study entry.
- Pregnant or breast-feeding.
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 |
|---|---|---|
| Valbenazine Oral CapsuleAlso: IngrezzaOpen-label twenty-four-week treatment with valbenazine oral capsules (up to 80 mg/day) to test the safety and effectiveness of this medication in ameliorating the signs of tardive dyskinesia in persons with intellectual disability. | Drug | Valbenazine |
Primary outcome
Change in AIMS total scores of items 1-7
Time frame: Baseline and 24 weeks from start of treatment
The Abnormal Involuntary Movement Scale (AIMS) has been used for many years as the gold standard for this purpose and the amount of improvement (change in movement intensity, and reduction in AIMS scores) have been assessed clinical significance in rating improvement. A number of authors have noted the difficulty in using the AIMS in persons with IDD who cannot cooperate fully in the examination process. For this reason, some have suggested using videotaped AIMS exams as a methodology for more accurately quantifying change. Videotaping of exams pre- and post-treatment for blind rating of improvement has been a methodology utilized in a number of recent studies of valbenazine. The minimum value of the AIMS total score of items 1-7 is 0 and the maximum value is 49. Higher total AIMS scores mean worse outcomes.
6 secondary outcomes
Change in AIMS item 8 scores
Time frame: Baseline and 24 weeks from start of treatment
CGI-C
Time frame: Baseline and 24 weeks from start of treatment
CaGI-C
Time frame: Baseline and 24 weeks from start of treatment
Change in ABC-I score
Time frame: Baseline and 24 weeks from start of treatment
Change in W-ADL score
Time frame: Baseline and 24 weeks from start of treatment
Change in Zarit Burden Interview (short version) score
Time frame: Baseline and 24 weeks from start of treatment
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 24 Oct 2024.
- BackgroundAman MG (2012) Aberrant Behavior Checklist: Current Identity and Future Developments. Clin Exp Pharmacol 2:e114. doi:10.4172/2161- 1459.1000e114
- Background: PubMed 14870947Barnes TR. The Barnes Akathisia Rating Scale--revisited. J Psychopharmacol. 2003 Dec;17(4):365-70. doi: 10.1177/0269881103174013.
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- Individual participant dataSharing planned: Yes. Trial data can be made available on reasonable request to the principal investigator and must be accompanied by detailed study proposals, a description of study objectives, and a statistical analysis plan. Access to available deidentified participant data and the trial protocol may be granted 12 months after publication.
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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.
Stephen Ruedrich, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valbenazine Oral Capsule in people with Tardive Dyskinesia and Intellectual Disability, run by Stephen Ruedrich at 1 site in United States.
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 7 inclusion and 11 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 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 AIMS total scores of items 1-7 (time frame: Baseline and 24 weeks from start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06107829, which also lists 29 linked publications.
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 24 Oct 2024.