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Sponsor: Asklepios Biopharmaceutical, Inc.

Official Title:  A Phase 2, Randomized, Double-blind, Sham Surgery-controlled Study of the Efficacy and Safety of Intraputaminal AAV2-GDNF in the Treatment of Adults With Moderate Stage Parkinson's Disease

Purpose: The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease.

Study design: Randomized, surgically controlled, double-blinded

Study duration: 18 months

Basic inclusion criteria:

• Adults 45-75 years of age inclusive
• Diagnosed with Parkinson's Disease in the past 4-10 years (inclusive)
• Presence of motor fluctuations as measured by the PD Motor Diary
• Stable anti-parkinsonian medication regiment for >/= 4 weeks prior to screening
• Must demonstrate responsiveness to levodopa therapy

Basic exclusion criteria:

• Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis
• Presence or history of significant vascular and/or cardiovascular disease
• Presence of significant cognitive impairment, poorly controlled depression/anxiety
• Presence or history of psychosis or impulse control disorder
• History of malignancy other than treated cutaneous squamous or basal cell carcinomas
• Presence of clinically relevant conditions that could compromise surgical suitability and/or subject safety
• Contraindication to magnetic resonance imaging and/or use gadolinium-based contrast agents
• Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure
• Chronic immunosuppressive therapy

Sponsor: Intra-Cellular Therapies, Inc.

Official Title: A Randomized, Double-blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease

Purpose: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a diagnosis of Parkinson's Disease consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria, who are experiencing wearing off symptoms and levodopa-induced dyskinesia.

Study design: Randomized, double-blind, placebo-controlled

Study duration: 9 Weeks

Basic inclusion criteria:

• Male or female between 40 and 80 years of age, inclusive
• Body mass index of 19.0-40.0 kg/m2;
• Diagnosis of PD
• Have a clinically meaningful response to levodopa (levodopa + DDCI combination) based on Investigator assessment, and meet the following:

• Have been on a stable and optimal dose of levodopa (levodopa + DDCI combination: minimum dose of levodopa equivalent to 100 mg three times daily) for at least 4 weeks prior to Screening, and are expected to continue the same dose regimen throughout the Double-blind Treatment Period;
• If taking other anti-parkinsonian medications (MAO-B [monoamine oxidase B] inhibitor, COMT [catechol-O-methyltransferase] inhibitor, dopamine agonist) in addition to levodopa, have been on a stable dose for at least 4 weeks prior to Screening and are expected to continue the same dose regimen throughout the Double-blind Treatment Period;
• Have wearing-off symptoms and levodopa-induced dyskinesia as per Investigator judgment;
• Properly complete and return a self-reported home diary for motor function status
• Has a caregiver to assist with study participation, if determined by the Investigator to be necessary.

Basic exclusion criteria:

1. Medical history indicating parkinsonism other than idiopathic PD, including but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia;
2. Has late-stage PD, severe peak-dose dyskinesia, clinically significant end-dose or biphasic dyskinesia, and/or unpredictable or widely swinging fluctuations in their symptoms as assessed by the Investigator;
3. Exhibits clinical signs of dementia
4. Use of moderate or strong CYP3A4 inhibitors within 5 half-lives of Baseline or CYP3A4 inducers within 2 weeks of Baseline;
5. Daily use of nonsteroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid (ASA);
6. Use of MAO-A inhibitors, phosphodiesterase type 5 (PDE5) inhibitors, or alpha blockers including tamsulosin, within 5 half-lives of Baseline;

Sponsor: Cerevance

Official Title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of CVN424 in Parkinson's Disease Patients With Motor Complications

Purpose:  This is a randomized, double-blind, placebo-controlled, multicenter study in participants with Parkinson's disease (PD) with motor fluctuations. Participants will be randomized to receive once-daily oral doses of either 75 milligrams (mg) CVN424, 150 mg CVN424, or a matching placebo for 12 weeks. Participants who successfully complete this study and retain eligibility/suitability will be invited to participate in a future open-label extension (OLE) study.

Study design: Randomized, double-blind, placebo-controlled

Study duration: 12 weeks

Basic inclusion criteria:

• 30 years and older
• Diagnosis of PD .
• Body Mass Index (BMI) > 18.0 and < 35.0 Kilograms per meter square (kg/m^2), inclusive at Screening.
• Freely ambulatory at the time of Screening (with/without assistive device).
• PD medications must be stable for at least 4 weeks prior to Screening; monoamine oxidase B (MAO-B) inhibitors must be stable for at least 12 weeks prior to Screening.
• Levodopa administration at least 4 times daily (immediate or extended release) or three times daily (Rytary).
• Stable use of oral anti-sialorrhea medications for 30 days before Screening, without anticipated need for change during the study.
• During Screening, capable of adequately identifying ON, OFF, and dyskinetic states (>80% concordance with a blinded rater) through properly completed ON/OFF diaries.
• Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 12 weeks after the last dose of study drug has been taken.
• Able and willing to give written informed consent approved by an institutional review board, and to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures.

Basic exclusion criteria:

• Diagnosis of secondary or atypical parkinsonism.
• Severe or disabling dyskinesias or OFF expected to preclude successful study participation, in the opinion of the investigator.
• Any previous procedure or therapy designed to provide continuous levodopa or stimulation of dopaminergic tone (i.e., Duopa, apomorphine), surgery for PD (i.e., deep brain stimulation [DBS]), or anticipation of these during the study.
• Clinically significant orthostatic hypotension (consistently symptomatic or requires medication).
• Clinically significant hallucinations requiring antipsychotic use.
• Routine use of PD on-demand medications (i.e., inhaled levodopa)
• Use of injectable botulinum medication for sialorrhea within 90 days of screening or during the study.
• Clinically significant medical, surgical, psychiatric, or laboratory abnormalities that in the judgment of the investigator would preclude adequate participation or completion of the study.
• Clinically significant ECG abnormalities at Screening.
• Clinically significant heart disease within 2 years of Screening
• Active major depressive disorder
• Has active suicidal ideation within one year prior to Screening or attempted suicide within the last 5 years.
• Has been diagnosed with or history of a substance-related disorder (excluding nicotine and caffeine), including alcohol-related disorder, during the 12 months prior to Screening.
• Tests positive at Screening for drugs of abuse (opiates, tetrahydrocannabinol [THC], methadone, cocaine, and amphetamines [including ecstasy]).
• Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCV) antibody, or Human Immunodeficiency Virus (HIV) infection at Screening.
• Currently participating in or has participated in another study of an investigational medicinal product (IMP) or medical device in the last 3 months or within 5 half-lives of the IMP (whichever is longer) prior to Screening.

Sponsor: Neuron23 Inc.

Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson's Disease

Purpose:  The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 50-80 years with early Parkinson's Disease (PD) who have predicted elevations in the activity of the "leucine-rich repeat kinase 2" ("LRRK2" for short) pathway based on their genetic profile. A DNA test will be used to identify the "LRRK2-driven" population with predicted elevation in the LRRK2 pathway.

Study design: Randomized, double-blind, placebo-controlled

Study duration: 52 weeks

Basic inclusion criteria:

• Aged 50-80 years at time of screening, inclusive
• Diagnosis of clinically established or clinically probable Parkinson's Disease (PD)
• LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx)

Basic exclusion criteria:

• Secondary or atypical parkinsonian syndromes
• Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) >8%
• Other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening)

None at this time

Sponsor: Ono Pharmaceutical Co. Ltd

Official Title: A Phase 2, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Potential Efficacy of Multiple Doses of ONO-2808 in Patients With Multiple System Atrophy (MSA)

Purpose: To evaluate 3 doses of ONO-2808 compared to placebo in MSA patients, including: 1) safety and tolerability, 2) pharmacokinetics, and 3) changes in clinical outcome assessments (COA) and biomarkers considered to be related to the pharmacodynamics and potential efficacy of ONO-2808.

Study design: Randomized, double-blind, parallel-group, placebo-controlled

Study duration: 28 weeks

Basic inclusion criteria:

• Female or male patients with a diagnosis of clinically-established or clinically-probable MSA according to the novel Movement Disorder Society (MDS) criteria for MSA diagnosis (2022), including patients with MSA of either subtype (MSA-P or MSA-C).
• Patients at the early stages of the disease, defined as a maximum of 5 years since the onset of one of the following symptoms associated with MSA:
  • Parkinsonism
  • Ataxia
  • Orthostatic hypotension and/or urinary dysfunction
• Patients with an anticipated survival of at least 3 years in the opinion of the Investigator.
• Patients who are able to ambulate without the assistance of another person, defined as the ability to take at least 10 steps and then to turn around and walk at least another 10 steps. Use of assistive devices (e.g., walker or cane) is allowed.
• Ability to swallow oral medication and be willing to adhere to the study intervention regimen.

Basic exclusion criteria:

• Pregnant or lactating females.
• Patients with a clinically-significant or unstable medical or surgical condition other than MSA that, in the opinion of the Investigator, might preclude safe completion of the study or might affect the results of the study (e.g., pulmonary, cardiovascular [including bradyarrhythmia], macular edema, and significant renal or hepatic dysfunction).
• Neurological diseases/disorders other than MSA, such as Parkinson's disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, normal pressure hydrocephalus, pharmacological, or post-encephalitic parkinsonism.
• Patients with documented liver diseases or cirrhosis.
• Positive results at Screening for active viral infections that include positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis B core antibody, and hepatitis C virus (HCV).
• Patients who have made a suicide attempt in the 6 months before Screening

Sponsor: Theravance Biopharma

Official Title: A Phase 3, Multi-center, Randomized Withdrawal and Long Term Extension Study of Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Participants With Multiple System Atrophy

Purpose: To evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE).

Study design:  Open Label followed by Randomized Parallel Assignment

Study duration: 20 Weeks

Basic inclusion criteria:

• Participant is male or female and at least 30 years old.
• Participant has a diagnosis of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C)
• Participant must meet the diagnostic criteria of nOH, as demonstrated by a sustained reduction in BP of ≥20 mmHg (systolic) or ≥10 mmHg (diastolic) within 3 min of standing as part of orthostatic standing test or being tilted up ≥60o from a supine position as determined by a tilt-table test.
• Participant must be willing to not take any prohibited medications during the study.
• Participant is willing and able to provide signed and dated written informed consent to -participate prior to initiation of any study related procedures
• Participant is able to communicate well with the Investigator and clinic staff, understands the expectations of the study and is able to comply with the study procedures, requirements, and restrictions.

Basic exclusion criteria:

• Participant has a systemic illness known to produce autonomic neuropathy, including, but not limited to, amyloidosis and autoimmune neuropathies. Participant with diabetes mellitus (DM) will be evaluated on a case-by-case basis by the medical monitor and considered ineligible unless they meet all of the following criteria:
  • Well controlled type-2 DM in treatment with only oral medications and diet
  • HbA1C of ≤7.5% performed during screening or up to 12 weeks before screening
  • No clinically evident peripheral neuropathy (e.g., normal sensory examination on peripheral extremities)
  • No known retinopathy (e.g., annual ophthalmic exam is sufficient)
  • No nephropathy (e.g., absence of albuminuria and GFR >60).
• Participant has a known intolerance to other NRIs or SNRIs.
• Participant currently uses concomitant antihypertensive medication for the treatment of essential hypertension.
• Participant has used strong CYP1A2 inhibitors or inducers within 7 days or 5 half lives, whichever is longer, prior to Visit 2 (Day 1) or requires concomitant use until the Safety follow-up Visit.
• Participant has changed dose, frequency, or type of prescribed medication for orthostatic hypotension within 7 days prior to Visit 2 (Day 1).
• Midodrine and droxidopa (if applicable) must be tapered off and stopped at least 7 days prior to Visit 2 (Day 1).
• Participant has known or suspected alcohol or substance abuse within the past 12 months
• Participant has clinically unstable coronary artery disease or had a major cardiovascular event (e.g., myocardial infarction) in the past 6 months.
• Participant has significant uncontrolled cardiac arrhythmia, history of complete heart block, or significant QTc prolongation.
• Participant has a new onset of a neurological event (i.e., seizures, confusion, altered levels of consciousness, etc.) in the past 6 months.
• Participant has used any monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 2 (Day 1).
• Participant has a history of untreated closed angle glaucoma, or treated closed angle glaucoma that, in the opinion of an ophthalmologist, might result in an increased risk to the participant.
• Participant is unable or unwilling to complete all protocol specified procedures including questionnaires.
• Participant has known congestive heart failure (New York Heart Association [NYHA] Class 3 or 4).
• Participant has had any malignant disease, other than carcinoma in situ of the cervix or basal cell carcinoma, within the past 2 years prior to Screening.
• Participant has a known gastrointestinal (GI) condition, which in the Investigator's judgment, may affect the absorption of study medication (e.g., ulcerative colitis, gastric bypass).
• Participant has psychiatric, neurological, or behavioral disorders that may interfere with the cognitive ability of the participant to give informed consent, understand and comply with study procedures, or interfere with the conduct of the study.
• Participant has demonstrated lifetime suicidal ideation and/or suicidal behavior.
• Major surgery (i.e., procedures involving higher risk for infection and extended recovery period, such as, joint replacement, gastric bypass, open heart surgery, organ transplant, etc.) occurring less than 4 weeks prior to enrollment.

Sponsor: Scion NeuroStim

Official Title: Simple, Home-use Neurostimulation tReatment for Parkinson's Disease dEmeNtia

Purpose:  To evaluate the feasibility and safety of treatments with a non-invasive neuromodulation device in adults diagnosed with mild/moderate Parkinson's disease dementia (PDD). A non-invasive device is a device that stays outside of the body and is not implanted and does not penetrate the skin.

Neuromodulation means that the device stimulates activity in the brain.

Study design: Open-label

Study duration: 12 weeks

Basic inclusion criteria:

• Participants with clinical diagnosis of probable PDD
• Positive response to levodopa and have been treated with levodopa-based therapies for minimum of one years
• Participants must be willing and able to comply with all study requirements
• Participants must expect that the participant will be able to remain on a stable regimen of concomitant therapies used for the management of PD and not to introduce new medications used to treat PD (motor or non-motor symptoms) during the study
• Participant must have a study partner (defined as someone who sees the participant for more than three hours a day, 5x per week) that is willing to consent and participate in the trial.

Basic exclusion criteria:

• Participant anticipates being unable to attend all visits and complete all study activities during the trial
• Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the trial
• Has experienced a heart attack, angina, or stroke within the past 12 months or transient ischemic attack (TIA) within the past 6 months
• Are being treated with another neurostimulation device
• Demonstrate suicidality
• Have been previously diagnosed with either central vestibular dysfunction (lifetime) or have experienced l peripheral vestibular dysfunction within the last 12 months.
• Have active ear infections, perforated tympanic membrane or labyrinthitis, as identified by a general ear examination
• Have a recent history of frequent ear infections (≥ 1 per year over the past two years)
• Have a cochlear implant, myringotomy tubes or hearing aids that cannot be easily/reliably removed for treatment
• Have chronic tinnitus

Parkinson’s Progression Markers Initiative (PPMI)

Sponsor: The Michael J. Fox Foundation

Duration: 5+ years (up to 13 years total)

Brief summary: PPMI aims to better understand how Parkinson’s disease (PD) starts and changes over time. The study follows groups of people, including those both with and without Parkinson’s disease. The information from this study could transform how we diagnose, treat, and potentially prevent PD.

Basic eligibility criteria:

• Individuals who are at least 60 years old and are: First-degree family members (parent, child, sibling) of a person with Parkinson’s OR

• • People who have risk factors for the development of PD (known genetic mutation, loss of smell, history of physically acting out dreams during sleep, and others)
• People without Parkinson’s and no known risk to act as a comparison group

What: The Speech Science and Disorders Lab is conducting a research study to develop a technology-enabled tool for remote assessment and monitoring of voice changes and guiding self-administered speech exercises

Why: Abnormal voice is a hallmark feature of many neurologic diseases.  Finding an efficient and reliable way of registering voice changes can not only help patients to self-monitor their health but also help clinicians to deliver appropriate and timely care.

How: Participants will complete a self-administered 1-hour remote study session every 1-2 months for up to 12 months.  Participation requires: (1) a self-supplied electronic device such as a computer or tablet with reliable internet access and a video camera, (2) a microphone for voice recording, and (3) a headphone for sound playback.  Participants will access the study via an online program.  In each session, participants will complete a few questionnaires and perform various speaking tasks.  All procedures involve minimal risks.

Where: A quiet environment of participant's own choice (e.g., participant's home).

Criteria:

• Are 18 years or over
• Speak American English as your first and primary language
• Are diagnosed with a neurologic disease such as ALS, Parkinson's disease, Huntington's disease, muliple sclerosis, cerebellar ataxia, etc.
• Have no history of other neurologic disorders than your primary diagnosis

Compensation: $15 compensation for each remote study session

For more information, please contact: 785-864-0053 or MSDProject.SSDLab@gmail.com 

Purpose: Researchers are studying mild exercises for sleep quality in people with Parkinson's disease.  

Who: Ages 40-75 years, Diagnosis of idiopathic PD

What:

• Mild exercise at home for 12 weeks
• 15 to 20 minutes per exercise session
• Online group meeting once per week

Compensation: Up to $100 ($50 per visit to the research lab)

Contact: Elvira O'Neal, eoneal@kumc.edu, 913-251-7822 or Wen Liu, wliu@kumc.edu, 913-588-4565