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Research and Clinical Trials

Below is a listing of studies for which the Parkinson's Disease and Movement Disorder Center is currently enrolling participants.  A brief description and main inclusion/exclusion criteria are listed in each section. If you are interested in obtaining more information or possibly participating in one of the studies please contact:

Kelly Lyons, Ph.D.
klyons@kumc.edu or 913-588-7159

Clinical Trials for Parkinson's Disease with Mild Cognitive Impairment

Sponsor: Sage Therapeutics

Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of SAGE-718 in Parkinson's Disease Cognitive Impairment

Purpose: To evaluate the effect of SAGE-718 on cognitive performance in participants with Parkinson's disease mild cognitive impairment (PD-MCI).

Study design: Randomized, Double-Blind, Placebo-Controlled

Study duration: Approximately 70 days

Basic Inclusion Criteria:

  1. 50 – 75 years
  2. Meet criteria for PD-MCI
  3. Have stable motor symptoms for at least 4 weeks prior to Screening, in the opinion of the investigator.

Basic Exclusion Criteria:

  1. Have a diagnosis of dementia of any etiology, including but not limited to: Dementia associated with PD (probable or possible), dementia with Lewy bodies, Alzheimer's dementia, and vascular dementia.
  2. Have any parkinsonism other than PD, including secondary parkinsonism or atypical parkinsonism.
  3. In the opinion of the investigator, be experiencing fluctuations in motor symptoms associated with PD that will interfere with completing study procedures.
  4. Have an ongoing central nervous system condition other than PD that in the opinion of the investigator could influence the outcome of the study.
  5. Have experienced significant psychotic symptoms, including hallucinations or delusions, within the past 3 months, in the opinion of the investigator.
  6. Have a history of brain surgery, deep brain stimulation, or any history of hospitalization due to a brain injury.

Have a history, presence, and/or current evidence clinically relevant intracranial abnormality (e.g., stroke, hemorrhage, space-occupying lesion).

Studies for Essential Tremor

Sponsor: Sage Therapeutics

Official title:  A Phase 2 Double-Blind, Randomized, Placebo-Controlled, Dose-Response Study of SAGE-324 for the Treatment of Essential Tremor

Purpose: To evaluate the dose-response relationship of different doses of SAGE-324 on upper extremity tremor in participants with essential tremors (ET).

Study design: Randomized, double-blind, placebo controlled

Study duration: Approximately 90 days

Basic inclusion criteria:

  1. Diagnosis of ET, at least 3 years duration
  2. Absence of other neurological signs, such as dystonia, ataxia, or parkinsonism, isolated focal tremors (eg, voice, head), task- and position-specific tremors, sudden tremor onset, or evidence of stepwise deterioration of tremor.
  3. Willing to discontinue medications taken for the treatment of ET at least 14 days or 5 half-lives (whichever is longer) prior to receiving the investigational product (IP). Medications taken for the treatment of ET that were discontinued prior to receiving IP may be resumed following Day 97.

Basic exclusion criteria:

  1. Presence of known causes of physiological tremor.
  2. Recent exposure (14 days prior to Day 1) to tremorgenic drugs or presence of alcohol withdrawal state.
  3. Direct or indirect injury or trauma to the nervous system within 3 months before the onset of tremor.
  4. Previous procedure for the treatment of ET, deep brain stimulation, brain lesioning, or magnetic resonance (MR) guided procedure, eg, MR-guided focused ultrasound.

Official title: A Phase 2b, 12-week, Double-blind, Placebo-controlled, Randomized, Parallel Group, Multicenter Study of the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor

Purpose: To evaluate the safety and efficacy of JZP385 in the treatment of adult participants with moderate to severe ET..

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

Study duration: Approximately 12 weeks

Basic inclusion criteria:

  1. Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent.
  2. Participants who are diagnosed with ET (including ET plus).
  3. Participants have moderate to severe disability associated with tremor
  4. Sex and Contraceptive/Barrier Requirements

Basic exclusion criteria:

  1. Known history or current evidence of other medical or neurological conditions that may cause or explain the participant's tremor.
  2. Severe cognitive impairment
  3. History (within past 2 years at screening) or presence of substance use disorder (including alcohol) according to DSM-5 criteria, known drug dependence, or seeking treatment for alcohol or substance abuse related disorder. Nicotine use disorder is excluded if it impacts tremor.
  4. Prior magnetic resonance (MR)-guided focused ultrasound, surgical intervention (eg, deep brain stimulation, ablative thalamotomy, gamma knife thalamotomy), or inability to refrain from using a device for treatment of tremor for the duration of the treatment period.
  5. Botulinum toxin injection in the 6 months before screening or planned use at any time during the study.
  6. Treatment with any medication that could affect the evaluation of tremor within 2 weeks or 5 half-lives (whichever is longer) before screening or planned use at any time during the study.
  7. Use of prescription or nonprescription drugs, or other products (eg, grapefruit, grapefruit juice, or Seville oranges) known to be strong or moderate inhibitors of CYP3A4, that cannot be discontinued 2 weeks or 5 half-lives, whichever is longer, before Baseline or planned use at any time during the study.
  8. Use of proton pump inhibitors and histamine-2 receptor antagonists, which cannot be discontinued at least 2 weeks before Baseline, or planned use at any time during the study (occasional use of antacids will be permitted, but antacids should be taken at least 4 hours apart from study intervention).
  9. Inability to refrain from use of medication/substance(s) that might produce tremor or interfere with the evaluation of tremor on study visit days, such as, but not limited to, stimulant decongestants, beta-agonist bronchodilators, and alcohol.
  10. Regular use of more than 3 units of alcohol per day.
  11. Regular consumption of caffeine > 400 mg/day or > 4 cups of coffee per day.
Studies for Parkinson's Disease Patients Taking No or Limited Medications

Sponsor: UCB Biopharma SRL

Official title: A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson's Disease

Purpose: To assess the safety and tolerability of UCB0599 and to demonstrate the superiority of UCB0599 over placebo with regard to clinical symptoms of disease progression over 12 and 18 months in participants diagnosed with early-stage Parkinson's Disease.

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

Study duration: 18 months

Basic inclusion criteria:

  • Study participant must be 40 to 75 years of age inclusive, at the time of signing the informed consent
  • Study participant has Parkinson's Disease (PD), with a diagnosis made by a neurologist within 2 years of Baseline Visit (including diagnosis during Screening)
  • The following diagnostic criteria must be met: bradykinesia AND at least ONE of the following: muscular rigidity, or resting tremor
  • A Screening Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT), or a historical DaT-SPECT within 3 months of the Screening Visit that has been qualified by the central reader, shows evidence of dopamine transporter deficit per study requirements and as determined by a central reader
  • Study participant has never taken medications for the treatment of motor symptoms of PD and is not expected to require starting symptomatic treatment (ST) with a high likelihood in the next 6 months as far as clinical judgement allows
  • Study participant has never taken part in disease-modifying treatment studies directed at neurodegenerative disease (NDD)
  • Study participant has a body mass index (BMI) of 16 to 34kg/m² (inclusive)

Basic Exclusion Criteria:

  • Study participant has a brain magnetic resonance imaging (MRI) scan performed during Screening indicative of a clinically significant abnormality or a historical MRI scan during the 6 months before Screening Visit 1 of sufficient quality to show such abnormalities.
  • Study participant has any contraindication for the brain MRI or Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) imaging
  • Study participant has abnormalities in lumbar spine previously known or determined by a Screening lumbar x-ray (if conducted) that could preclude lumbar puncture, in the opinion of the Investigator. The participant must be excluded from lumbar puncture but not from study participation
  • Study participant has clinically significant electrocardiogram (ECG) abnormality at Screening, in the opinion of the Investigator
  • Study participant has past history of use of medications for the treatment of motor symptoms of PD. Short (up to 4 weeks) past use of medications for the treatment of motor symptoms is permitted following a sufficient washout period. Medications included are: levodopa (maximum 400mg per day), dopamine agonists, monoamine oxidase B (MAO-B) inhibitors, anticholinergics, or amantadine. A sufficient washout period is at least 3 months prior to the Baseline Visit

Sponsor: Cerevel Therapeutics, LLC

Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL)

Purpose: To evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.

Study design: Randomized, Double-blind, Placebo-controlled

Study duration: 27 Weeks

Basic inclusion criteria
1. Male and female participants aged 40 to 80 years, inclusive, at the time of signing the ICF (Informed consent form).
2. Participants with disease duration (from time of diagnosis) of less than (<) 3 years and disease progression in the 3 years before signing the informed consent form (ICF)
3. Participants with early PD who, in the opinion of the investigator, require pharmacologic intervention for disease management
4. Participants who are willing and able to refrain from any PD medications that are not permitted by the protocol (including dopaminergic agents) throughout participation in the trial

Basic Exclusion Criteria
1. Participants with a history of nonresponse or insufficient response to L-Dopa or 2 or more other antiparkinsonian drugs at therapeutic dosages
2. Participants with a history or current diagnosis of a clinically significant impulse control disorder 
3. Participants with the presence of or history of brain tumor, hospitalization for severe head trauma, epilepsy (as defined by the International League Against Epilepsy), or seizures
4. Participants with a history of psychosis or hallucinations within the previous 12 months based on medical records or participant/caregiver feedback
5. Participants with any condition that could possibly affect drug absorption, including bowel resections, bariatric weight loss surgery, or gastrectomy (this does not include gastric banding)

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson's Disease

Purpose: To evaluate the efficacy, safety and tolerability of two doses of K0706 compared to placebo in subjects with early Parkinson's Disease who are not receiving dopaminergic therapy.

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

Study duration: Approximately 40 weeks

Basic inclusion criteria:
1. 50 years and older
2. Diagnosed with "Clinically Probable PD", with documented onset of symptoms per treating physician's records within three years of the Screening visit.
3. Projected to not require to start dopaminergic therapy within 9 months from Baseline.

Basic exclusion criteria:
1. Current, or within 60 days of Screening, use of any prescription, investigational, or over the counter medication for the symptomatic treatment of PD or to slow the progression of PD. Treatment with Monoamine Oxidase B (MAOB) inhibitors will be allowed if the dose is stable for at least 30 days prior to Screening and subjects agree to remain on it for the duration of the study.
2. Prior use of dopaminergic therapy (e.g., levodopa, dopamine agonist, amantadine) for 30 or more days any time in the past.
3. Any clinically significant cardiac abnormality in the opinion of the investigator, this would include myocardial infarction in the six months prior to screening.
4. Subject report of recent (6-month) illicit drug use (other than marijuana), or excessive intake of alcohol (as per investigator opinion).
5. Subject report of marijuana use within one month of Screening or subject not willing to forgo marijuana use through the trial.
6. Any malignant disease other than basal cell carcinoma of the skin with evidence of disease within the past 5 years, or with the potential for recurrence.

Studies for Stable Parkinson's Disease Patients

Sponsor: Hoffman-La Roche

Official title: A Phase IIB, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease

Purpose: To evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.

Study design: Randomized, Double-blind, Placebo-controlled

Study duration: Minimum of 76 weeks

Basic inclusion criteria

1.  Diagnosis of idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism
2.  On symptomatic PD medication for at least 6 months, with stable doses for 3 months prior to baseline
3.  A diagnosis of PD for at least 6 months to maximum 3 years at screening
4.  Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) imaging consistent with dopamine transporter deficit, as assessed by the central reader
5.  No anticipated changes in PD medication from baseline throughout the study duration based on clinical status during screening
6.  Willingness and ability to use a smartphone application to measure PD-related symptoms for the duration of the study
7.  Willingness and ability to wear a smartwatch to measure PD-related motor signs

Basic Exclusion Criteria

1.  Medical history indicating a Parkinsonian syndrome other than idiopathic PD
2.  Diagnosis of PD dementia
3.  Diagnosis of a significant central nervous system (CNS) disease other than Parkinson's disease
4.  Within the last year, unstable or clinically significant cardiovascular disease
5.  Uncontrolled hypertension
6.  Drug and/or alcohol abuse within 12 months prior to screening, in the investigator's judgment (Nicotine is allowed, Marijuana use is not allowed)
7.  Any contraindications to obtaining a brain magnetic resonance imaging (MRI)
8.  Any contraindications to DaT-SPECT imaging

 

Studies for Parkinson's Disease Patients with Off-Time

Sponsor: Cerevel Therapeutics, LLC

Official Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson's Disease

Brief Summary: The purpose of this study is to assess the effect of tavapadon on the change from baseline in total daily hours of "on" time without troublesome dyskinesia in L-Dopa-treated participants with Parkinson's Disease (PD) who are experiencing motor fluctuations

Study duration: 27 Weeks

Study design: Randomized, double-blind, placebo controlled

Basic Inclusion Criteria:

  • Male and female participants aged 40 to 80 years, inclusive
  • Participants who are capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • Participants with a good response to levodopa (L-Dopa) in the judgment of the investigator.
  • Participants who return a completed self-reported home diary for motor function status (Hauser diary) during the screening period (after diary training and concordance testing has occurred), with recordings for 2 consecutive days (ie, 2 consecutive 24-hour periods) showing at least 2 and half hours of "off" time on each of the 2 days.
  • Participants who are on a stable dose of L-Dopa for at least 4 weeks prior to screening and are taking a minimum total daily dose of 400 milligram (mg) divided in at least 4 doses per day of standard carbidopa/levodopa or divided in at least 3 doses per day of extended-release carbidopa/levodopa capsules.
  • Prior and concurrent use of COMT inhibitors, MAO-B inhibitors, amantadine, or anticholinergic drugs is permitted if use was initiated greater than (>) 90 days before signing of the informed consent, the dosage has remained stable for a minimum of 4 weeks.

Basic Exclusion Criteria:

  • Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome
  • Participants with a history or current diagnosis of a clinically significant impulse control disorder (Disruptive, Impulse Control, and Conduct Disorder per DSM-5).
  • Participants with a history of psychosis or hallucinations within the previous 12 months.
  • Participants with substance abuse or dependence disorder, including alcohol, benzodiazepines, and opioids, but excluding nicotine, within the past 6 months .
  • Participants with dementia or cognitive impairment that, in the judgement of the investigator, would exclude the participant from understanding the ICF or participating in the trial.
  • Participants with any condition that could possibly affect drug absorption, including bowel resections, bariatric weight loss surgery, or gastrectomy (this does not include gastric banding).
  • Participants who have a positive result for human immunodeficiency virus (HIV)
  • Participants with other abnormal laboratory test results, vital sign results, or ECG findings unless, in the judgment of the investigator, the findings are not medically significant and would not impact the safety of the participants or the interpretation of the trial results.
Studies for Parkinson's Disease Patients With Dyskinesia

Official title: A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson's Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and Its Individual Components

Sponsor: Bukwang Pharmaceutical

Brief Summary: This is a two-part, double-blind, placebo-controlled, randomized, multicenter Phase 2 clinical trial of JM-010 in patients with Parkinson's Disease.

Study design: Randomized, Double-Blind, Placebo-Controlled

Study duration: 12 weeks

Basic inclusion criteria:

  • Is male or female, between 18 and 80 years of age at Screening Visit.
  • Is diagnosed with idiopathic PD
  • Has experienced dyskinesia
  • Has stable peak-effect dyskinesia
  • Has more than one hour of "ON" time with troublesome dyskinesia

Basic exclusion criteria:

  • Has undergone surgery for the treatment of PD
  • Has a current diagnosis of Substance Use
  • Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses
  • Has current seizure disorders requiring treatment with anticonvulsants.
  • Other criteria related to other medical conditions to be referred to the protocol.

Non-medication Studies for Parkinson's Disease

STEM-PD

Sponsor: Scion NeuroStim

Official title: Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease: A Randomized Controlled Trial (RCT)

Brief Summary: To establish the safety and efficacy of a non-invasive neuromodulation device for treating symptoms associated with Parkinson's disease.

Study design: Randomized, double-blind, controlled

Study duration: 16 weeks

Basic Inclusion Criteria:

  • Adult participants (aged 18 - 85 years inclusive)
  • Diagnosed with Parkinson's disease according to the UK Brain Bank Criteria
  • Demonstrates a positive response to oral anti-Parkinsonian medications (i.e. dopamine replacement therapies) and treated with these medications for minimum of three years prior to the screening visit
  • Report limitation to activities of daily living (e.g., writing, walking, bathing, dressing, eating, toileting, etc.)
  • Able and willing to consent to participate in the study.
  • Fully vaccinated from COVID-19 (at least 2 weeks from their final dose) with one of the current World Health Organization evaluated vaccines, prior to Screen.
  • Have a study partner (defined as someone who sees the participant for more than one hour a day, 3 times per week) that is willing to consent and participate in the trial.
  • Have capabilities to use and access smartphones and or tablets for the collection of some study data.
  • Must be willing to answer questions related to sexual interest, arousal, and performance in an interview with study staff.

Basic Exclusion Criteria:

  • Participant anticipates being unable to attend all visits and complete all study activities.
  • Have a history or prior diagnosis of dementia or evidence of dementia at study screen.
  • Have experienced a myocardial infarction, angina, or stroke within the past 12 months.
  • Are receiving deep brain stimulation therapy.
  • Are treated with a pump for continuous delivery of dopamine replacement medication.
  • Use apomorphine rescue.
  • Have received MRI guided high intensity focused ultrasound within the past 12 months.
  • Experience frequent falls.
  • Work night shifts
  • Use a hearing aid that is implanted or that cannot be easily removed and replaced.
  • Have chronic (>3 months) tinnitus.
  • Have active ear infections, or other significant ear problems.
  • Have a recent history of frequent ear infections (≥ 1 per year over the past two years)
  • Have had eye surgery within the previous three months or ear surgery within the previous six months.

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)
  • Individuals who are least 30 years old and are:
    • People with Parkinson’s who have been diagnosed within the last two years and are not currently taking standard PD medications OR
  • 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

To receive more information or participate in a clinical trial

Parkinson's Disease and Movement Disorder Center

University of Kansas Medical Center
Parkinson's Disease and Movement Disorder Center
Mailstop 3042
3901 Rainbow Boulevard
Kansas City KS 66160
Appointments: 913-574-0038