Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities
NCT ID: NCT06107829
Last Updated: 2024-10-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
PHASE4
Study Classification
INTERVENTIONAL
Study Start Date
2025-01-31
Study Completion Date
2027-02-28
Brief Summary
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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.
* 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.
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Detailed Description
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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.
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.
Conditions
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Tardive Dyskinesia
Intellectual Disability
Developmental Disabilities
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Valbenazine
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.
Group Type
EXPERIMENTAL
Valbenazine Oral Capsule
Intervention Type
DRUG
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.
Interventions
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Valbenazine Oral Capsule
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.
Intervention Type
DRUG
Other Intervention Names
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Ingrezza
Eligibility Criteria
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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 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.
* 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.
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 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.
* 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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Neurocrine Biosciences
INDUSTRY
Sponsor Role
collaborator
Stephen Ruedrich
OTHER
Sponsor Role
lead
Responsible Party
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Stephen Ruedrich
Physician
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Stephen Ruedrich, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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University Hospitals of Cleveland
Cleveland, Ohio, United States
Site Status
Countries
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United States
References
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Aman MG (2012) Aberrant Behavior Checklist: Current Identity and Future Developments. Clin Exp Pharmacol 2:e114. doi:10.4172/2161- 1459.1000e114
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Correll 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.
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de 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.
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de 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.
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BACKGROUND
Fodstad 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.
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Guy 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.
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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.
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BACKGROUND
Hérbert, 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.
Reference Type
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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.
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Maenner 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.
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Matson 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.
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BACKGROUND
McEvoy 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.
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BACKGROUND
Morton 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.
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BACKGROUND
Ruedrich SL. (2016). Psychopharmacology. In Hemmings C & Bouras N (eds.) Psychiatric and Behavioural Disorders in Intellectual and Developmental Disabilities, Third Edition, Cambridge University Press, Cambridge, UK, 139-150.
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Ruedrich SL (2010). Mental Illness in O'Hara J, McCarthy J, and Bouras N. (eds.) Intellectual Disability and Ill Health: A Review of the Evidence, Cambridge University Press, Cambridge UK, 165-177.
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Ruedrich SL, Diana L, Rossvanes CF, Toliver J. (2005). The abnormal involuntary movement scale (AIMS) and tardive dyskinesia in persons with developmental disability: the benefit of videotaped exams. Mental Health Aspects of Developmental Disabilities 8(3)94-99.
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Schmidt S, Power M, Green A, Lucas-Carrasco R, Eser E, Dragomirecka E, Fleck M. Self and proxy rating of quality of life in adults with intellectual disabilities: results from the DISQOL study. Res Dev Disabil. 2010 Sep-Oct;31(5):1015-26. doi: 10.1016/j.ridd.2010.04.013. Epub 2010 May 15.
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Schooler NR, Kane JM. Research diagnoses for tardive dyskinesia. Arch Gen Psychiatry. 1982 Apr;39(4):486-7. doi: 10.1001/archpsyc.1982.04290040080014. No abstract available.
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Sheehan R, Horsfall L, Strydom A, Osborn D, Walters K, Hassiotis A. Movement side effects of antipsychotic drugs in adults with and without intellectual disability: UK population-based cohort study. BMJ Open. 2017 Aug 3;7(8):e017406. doi: 10.1136/bmjopen-2017-017406.
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Simpson GM, Angus JW. A rating scale for extrapyramidal side effects. Acta Psychiatr Scand Suppl. 1970;212:11-9. doi: 10.1111/j.1600-0447.1970.tb02066.x. No abstract available.
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BACKGROUND
Solmi M, Pigato G, Kane JM, Correll CU. Clinical risk factors for the development of tardive dyskinesia. J Neurol Sci. 2018 Jun 15;389:21-27. doi: 10.1016/j.jns.2018.02.012. Epub 2018 Feb 5.
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BACKGROUND
Stacy M, Sajatovic M, Kane JM, Cutler AJ, Liang GS, O'Brien CF, Correll CU. Abnormal involuntary movement scale in tardive dyskinesia: Minimal clinically important difference. Mov Disord. 2019 Aug;34(8):1203-1209. doi: 10.1002/mds.27769. Epub 2019 Jun 24.
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Yu J, Yap P, Liew TM. The optimal short version of the Zarit Burden Interview for dementia caregivers: diagnostic utility and externally validated cutoffs. Aging Ment Health. 2019 Jun;23(6):706-710. doi: 10.1080/13607863.2018.1450841. Epub 2018 Mar 19.
Reference Type
BACKGROUND
Other Identifiers
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STUDY20221555
Identifier Type: -
Identifier Source: org_study_id
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UNKNOWN
PHASE1
Randomized Controlled Trial of Pyridoxine for Tardive Dyskinesia
NCT03287778
COMPLETED
NA