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Movement Disorders Research

Huntington’s Disease


DM/Q for Irritability in HD

Investigator: Erin Furr-Stimming, MD

Purpose: To evaluate the efficacy of dextromethorphan/quinidine in treating Irritability in Huntington’s disease.
Key Inclusion Criteria: Adults 18-75 who are gene positive for HD with irritability symptoms.

Enrollment Status: Actively enrolling

Clinical Trials.gov NCT # https://clinicaltrials.gov/show/NCT03854019

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Child to Adult Neurodevelopment in Gene Expanded Huntington’s Disease (ChANGE-HD)

Investigator: Erin Furr-Stimming, MD

Purpose: To evaluate brain structure and function in children, adolescents, and young adults (ages 6-30) who are at risk for developing HD – those who have a parent or grandparent with HD. Key Inclusion Criteria 6-30 yrs at risk for HD, able to underfo MRI scans. (hx SZ,dx Juvenile HD, brain tumors, brain surgery, major head trauma are excluded.

Enrollment Status: Actively Enrolling

Clinical Trials.gov NCT # https://clinicaltrials.gov/show/NCT01860339

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A Phase I/II, Randomized, Double-blind, Sham Control Study to Explore Safety, Tolerability, and Efficacy Signals of Multiple Ascending Doses of Striatally-Administered rAAV5-miHTT Total Huntingtin Gene (HTT) Lowering Therapy (AMT-130) in Early Manifest Huntington Disease

Investigator: Erin Furr-Stimming, MD

Purpose: A Phase I/II, Randomized, Double-blind, Sham Control Study to Explore Safety, Tolerability, and Efficacy Signals of Multiple Ascending Doses of Striatally-Administered rAAV5-miHTT Total Huntingtin Gene (HTT) Lowering Therapy (AMT-130) in Early Manifest Huntington Disease. Key Inclusion Criteria Early Manifest HD, DCL = 3 or 4, age 25-65, Total Functional Capacity score of 9 – 13 • CAG repeat length ≥ 40 • Able to undergo MRI scans and Lumbar Punctures. (Prior history of gene therapy, RNA or DNA targeted HD investigational agents, ASOs, brain surgery and Suicidal ideation within past year is excluded)

Enrollment Status: Actively Enrolling

Clinical Trials.gov NCT # https://clinicaltrials.gov/show/NCT04120493

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HD-Clarity

Investigator: Erin Furr-Stimming, MD

Purpose: A multi-site cerebrospinal fluid collection initiative to facilitate therapeutic development for Huntington’s disease.

Key Inclusion Criteria: 21 -75 yrs and able to undergo LP, enrollment in Enroll-HD.

Enrollment Status: Actively enrolling

Clinical Trials.gov NCT # https://clinicaltrials.gov/show/NCT02855476

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Enroll-HD: A Prospective Registry Study in a Global Huntington’s Disease Cohort.

Investigator: Erin Furr-Stimming, MD

Purpose: To develop a comprehensive repository of prospective and systematically collected clinical research data and biological specimens from individuals with manifest HD, unaffected individuals known to carry the HD mutation or at risk of carrying the HD mutation, and control research participants (e.g., spouses, siblings or offspring of HD mutation carriers known not to carry the HD mutation).

Key Inclusion Criteria: All individuals who have a HD status of Positive, negative, unknown, and controls.

Enrollment Status: Actively enrolling

Clinical Trials.gov NCT # https://clinicaltrials.gov/show/NCT01574053

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KINECT-HD

Investigator: Paul Schulz, MD

Purpose: Neurocrine Biosciences Inc/ A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated with Huntington’s Disease.

Key Inclusion Criteria: Diagnosis of motor manifest HD at or before screening; • Naïve to VMAT 2 inhibitors

Enrollment Status: Actively enrolling 

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Parkinson’s Disease


PRILENIA

Investigator: Raja Mehanna, MD

Purpose: A Double-Blinded, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients with Parkinson’s Disease.

Key Inclusion Criteria: 30-85 yrs with dx of PD (Atypical parkinsons , clinically significant deficit from stroke within 6 months and history of surgical intervention related to PD excluded)

Enrollment Status: Actively Enrolling

Clinical Trials.gov NCT # https://clinicaltrials.gov/show/NCT03922711

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Acadia Pharmaceuticals/Management of Parkinsons Disease Psychosis in Actual Practice: “The INSYTE Study”

Investigator: Paul Schulz, MD

Purpose: Parkinsons Disease Psychosis (non-interventional study)

Key Inclusion Criteria: Age ≥ 18, with PDP; Ability to understand and read English

Clinical Trials.gov NCT #NCT03152292

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RESTORE Study

Investigator: Paul Schulz, MD David Hunter, MD

Purpose: VY-AADC02 for Parkinson’s Disease With Motor Fluctuation.

Key Inclusion Criteria: 40 -75 yrs; DX of PD; disease duration from diagnosis of ≥4 years.

Enrollment Status: Opening in near future

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FMT Study

Investigator: Mya Schiess, MD

Purpose: The purpose of this randomized. Controlled study is to characterize the intestinal microbiome in mild to moderate PD patients before and after fecal microbiota treatments. PRIM-DJ2727 vs placebo.

Key Inclusion Criteria: 55-75 yrs old with dx of PD in ≤ 10 years based on the United Kingdom Brain Bank Criteria; Robust response to dopaminergic therapy (Atypical, vascular or drug-induced Parkinsonism, (MoCA) Score ≤ 23 and unstable PD systemic therapy are excluded)

Enrollment Status: Status actively enrolling

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Medtronic Product Surveillance Study

Investigator: Mya Schiess, MD

Purpose: World registry of implanted Neuromodulation devices.

Key Inclusion Criteria: Patient has or is intended to receive or be treated with DBS or intrathecal baclofen pump, this would be a new or replacement neurostimulator or pump; mustbe accessible for follow up

Enrollment Status: Actively enrolling

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RESTORE Study

Investigator: Paul Schulz, MD David Hunter, MD

Purpose: VY-AADC02 for Parkinson’s Disease With Motor Fluctuation.

Key Inclusion Criteria: 40 -75 yrs; dx of PD; disease duration from diagnosis of ≥4 years.

Enrollment Status: Opening in near future

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A randomized, double-blind, placebo-controlled trial of Allogeneic Bone marrow-derived Mesenchymal Stem cell as a disease-modifying therapy for idiopathic Parkinson’s disease (MSCII Study)

Investigator: Mya Schiess, MD

Purpose: The purpose of this trial is to select the safest and most effective number of repeat doses of MSC to slow the progression of Parkinson’s Disease.

Key Inclusion Criteria: 50-79 years of age who meet the UK Brain Bank criteria for idiopathic PD ; Diagnosis of PD > 3 years and ≤ 10 years; Robust response to dopamine and currently on a stable dopaminergic treatment regimen (History of surgical intervention for PD such as DBS, or cognitive impairment are excluded)

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Detection of Alpha -Synuclein Oligomers in Blood for the diagnosis of Parkinson’s Disease

Investigator Mohammad Shahnawaz, PhD, Mya Schiess, MD

Purpose: To assess the use of peripheral alpha-synuclein oligomers as a possible biomarker for diagnosis and progression in Parkinson’s disease

Key Inclusion Criteria: 50-79 years of age who meet the UK Brain Bank criteria for idiopathic PD ; Diagnosis of PD > 3 years and ≤ 10 years; Robust response to dopamine and currently on a stable dopaminergic treatment regimen (History of surgical intervention for PD is excluded)

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RBD Study

Investigator: Mya Schiess, MD

Purpose: To Identify biomarkers of clinical progression and conversion to alpha-synucleinopathies in the RBD population.

Key Inclusion Criteria: 40-80 yrs with dx of idiopathic RBD by polysomnography, healthy controls, atypical parkinsonism or PD

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Neurocognitive Disorders

UTHealth Neurocognitive Disorders Biobank

Investigator: Paul Schulz, MD

Purpose: The UTHealth NCD Biobank will serve as a resource for researchers in the UTHealth System as well as external collaborators engaged in studies of Neurocognitive and other Neurological Disorders. The NCD Biobank will collect and archive whole blood (for RNA and DNA extraction), plasma, serum, urine, cerebrospinal fluid and oral fluids from adult patients and healthy volunteers visiting the Neurocognitive Disorders Center and the Department of Neurology at UTHealth.

Status: Actively Enrolling

Clinical Trials

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