Treatment Trials

29 Clinical Trials for Various Conditions

Focus your search

Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities
Description

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.

Conditions

Tardive Dyskinesia, Intellectual Disability, Developmental Disabilities

Studying Patterns in Patient Engagement Among Tardive Dyskinesia Patients
Description

The statistical analysis of the collected data aims to reveal the many factors that influence patient involvement in clinical trials. Findings will be disseminated through conferences and scholarly papers to benefit all parties participating in clinical trials. These findings will help to shape the design of future clinical trials for people with tardive dyskinesia, as well as enhance recruiting techniques and retention rates.

Conditions

Tardive Dyskinesia

Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities
Description

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.

Conditions

Tardive Dyskinesia, Intellectual Disability, Developmental Disabilities

Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes
Description

The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia.

Conditions

Tardive Dyskinesia

Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia
Description

This study will evaluate the effectiveness of valbenazine on patient- and clinician-reported outcomes assessing health-related quality of life, functioning, and treatment effect in participants with tardive dyskinesia (TD) who are receiving valbenazine for up to 24 weeks.

Conditions

Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Tardive Dyskinesia

Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine
Description

This will be an Investigator-initiated pilot study in which participants will be assessed with various scales to measure demoralization, anxiety, depression, and subjective incompetence at baseline and every two weeks after treatment with Valbenazine for a total of 6 weeks. Improvement in TD will be assessed as well and correlated with reduction in demoralization.

Conditions

Tardive Dyskinesia

Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
Description

This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the persistence of effect of valbenazine 40 mg and 80 mg.

Conditions

Tardive Dyskinesia (TD)

Randomized Controlled Trial of Pyridoxine for Tardive Dyskinesia
Description

Purpose: Tardive dyskinesia (TD) is a involuntary movement disorder that can occur following long term treatment with antipsychotic medications and for which few treatment options exist. This study will test the efficacy of pyridoxine (also known as vitamin B6) for TD. This will be an 8 week double-blind, placebo-controlled, randomized trial measuring the effect of pyridoxine 400 mg/day on the severity of involuntary muscle movements in people who meet Schooler-Kane criteria for TD. Participants: Approximately 50 subjects will be recruited from the UNC Schizophrenia Treatment and Evaluation Program (STEP) and other local psychiatric clinics. Procedures (methods): Symptoms of TD will be assessed using the Abnormal Involuntary Movement Scale (AIMS). Pharmacological Intervention: All participants who meet entry criteria will be randomized to one of two treatment groups: pyridoxine or placebo.

Conditions

Tardive Dyskinesia, Antipsychotic Agents

Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
Description

This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for the treatment of adults with TD until valbenazine is anticipated to be available commercially or they complete 72 weeks of treatment. This study will allow enrollment of up to 150 medically stable male and female participants with TD who previously participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.

Conditions

Tardive Dyskinesia

Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia
Description

Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately 150 medically stable male and female subjects with clinical diagnoses of schizophrenia or schizoaffective disorder with neuroleptic-induced TD or mood disorder with neuroleptic-induced TD.

Conditions

Tardive Dyskinesia

Addressing Involuntary Movements in Tardive Dyskinesia
Description

The purpose of this study is to determine whether fixed-doses of an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.

Conditions

Tardive Dyskinesia

A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia
Description

The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

Conditions

Tardive Dyskinesia

Reducing Involuntary Movements in Participants With Tardive Dyskinesia
Description

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe tardive dyskinesia. The purpose of part B is to establish the durability of effect of SD-809 following 1-week period of randomized withdrawal (SD-809 and placebo), followed by 12 weeks of maintenance with SD-809.

Conditions

Tardive Dyskinesia

Aim to Reduce Movements in Tardive Dyskinesia
Description

The purpose of this study is to determine whether an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.

Conditions

Tardive Dyskinesia

A Phase 2 Trial Evaluating SNC-102 in Drug-Induced Tardive Dyskinesia
Description

This Phase 2 study was designed to evaluate the efficacy and safety of SNC-102 in subjects with drug-induced Tardive Dyskinesia (TD). To ensure an adequate evaluation of SNC-102, a randomized, double-blind, parallel-group, placebo-controlled trial was designed. Two dosing levels of SNC-102 are employed to evaluate the proposed dosing range. A target enrollment of 90 subjects with drug-induced TD will provide sufficient data to assess the efficacy and safety profiles of SNC-102 in the target population.

Conditions

Drug-induced Tardive Dyskinesia

NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia
Description

The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

Conditions

Tardive Dyskinesia

NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)
Description

The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

Conditions

Tardive Dyskinesia

NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
Description

The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive dyskinesia in subjects with schizophrenia or schizoaffective disorder.

Conditions

Tardive Dyskinesia

Levetiracetam Treatment of Tardive Dyskinesia
Description

This is a placebo-controlled study designed to learn if levetiracetam is effective for tardive dyskinesia.

Conditions

Tardive Dyskinesia

Treatment of Tardive Dyskinesia With Galantamine
Description

Tardive dyskinesia (TD), a form of movement disorder, remains a problem for some patients who received antipsychotic medications. Increasing evidence suggests that TD may result from antipsychotic-induced dysfunction in striatal cholinergic neurons. To test whether cholinesterase inhibitors compensate for diminished cholinergic activity underlying TD, we conducted a 30-week randomized, double-blind, placebo-controlled crossover study of galantamine in 36 patients with TD.

Conditions

Tardive Dyskinesia

The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine
Description

This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the potential for clinical dependence and withdrawal symptoms associated with valbenazine.

Conditions

Tardive Dyskinesia (TD)

Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents
Description

Prospective study to quantify the prevalence of possible tardive dyskinesia (TD) in outpatient psychiatry practices in the United States (US), as well as to describe the associated disease burden in a cohort of patients with one or more psychiatric disorders and a cumulative lifetime exposure to antipsychotic medication of three months or more.

Conditions

Tardive Dyskinesia

The Assessment of Movement Disorders Utilizing Live Two-Way Video
Description

The purpose of this project is to determine the equivalency of extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) examinations conducted via live two-way video versus live examinations completed in-person

Conditions

Tardive Dyskinesia

Pimavanserin Treatment in TS
Description

This research study is determining if a drug called Pimavanserin if safe and effective in the treatment of the symptoms of Tourette Syndrome. Pimavanserin is an investigational drug for Tourette Syndrome, which means it has not been approved by the United States Food and Drug Administration (FDA) to treat Tourette Syndrome. Pimavanserin has been approved by the FDA as a treatment for hallucinations in Parkinson's Disease. It is currently marketed under the name NUPLAZID (pimavanserin) capsules by Acadia Pharmaceuticals.

Conditions

Tourette Syndrome, Tardive Dyskinesia

Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates
Description

To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in smoking status and neurological symptoms using standardized rating scales. The aim is to examine clinically significant effects on antipsychotic-induced neurological side effects that may warrant further investigation.

Conditions

Schizophrenia, Schizoaffective Disorder, Tobacco Smoking, Tardive Dyskinesia, Parkinsonism

Dysport for the Treatment of OMD
Description

The purpose of this study is to study the efficacy and safety of AbobotulinumtoxinA (Dysport) for use in Oromandibular Dystonia (OMD).

Conditions

Oral Dystonia, Tardive Dystonia

Heart Rate Variability in Response to Metformin Challenge
Description

Diseases caused by brain energy supply defects can be innate (fibromyalgia secondary to familial mitochondrial disorders) or acquired (tardive dyskinesia or weight gain associated with prolonged antipsychotic use). Patients with these possible mitochondrial disorders will provide a baseline resting heart rate sample, ingest low-dose metformin (500 mg), and then provide an additional sample 2 hours later.

Conditions

Fibromyalgia, Mitochondrial Diseases, Movement Disorders, Diabetes Mellitus, Type 2

Movement Disorders Caused by Antipsychotic Drugs in Older Patients
Description

This study will assess the risk of experiencing tardive dyskinesia and other movement disturbances associated with three atypical antipsychotic drugs among middle-aged and elderly psychiatric patients.

Conditions

Dyskinesia, Drug-Induced

Akathisia (Restless Legs Syndrome) in People With Schizophrenia and Mental Retardation
Description

Akathisia is a movement disorder that is often a side effect of certain psychiatric drugs. People with akathisia are unable to sit or keep still, complain of restlessness, fidget, rock from foot to foot, and pace. Akathisia is sometimes called "restless legs syndrome." The drugs that can cause akathisia are most often used to treat patients with schizophrenia or mental retardation (MR). This study will evaluate akathisia in both schizophrenic and MR patients who either have long-term akathisia or who are starting treatment with psychiatric drugs.

Conditions

Akathisia