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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, PhD
klyons@kumc.edu or 913-588-7159

Enrolling Clinical Trials

A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease

Sponsor: Neuraly, Inc.

Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment With NLY01 in Early-stage Parkinson's Disease

Brief Summary: This is a phase 2 study designed to assess the safety, tolerability and efficacy of NLY01 in subjects with early untreated Parkinson's disease (PD).

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

Duration: 36 weeks

Basic Inclusion Criteria
1. Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic criteria or Movement Disorder Society Research Criteria
2. DaTscan consistent with diagnosis of Parkinson's Disease
3. Men or women 30 to 80 years of age

Exclusion Criteria:
1. Diagnosis of secondary or atypical parkinsonism
2. Prior use of dopaminergic treatment or MAO-B inhibitors for more than 28 days
3. Medical or recreational use of marijuana or THC-containing compounds within 3 months of screening visit
4. Pregnant or planning to become pregnant

Fixed-Dose Trial in Early Parkinson's Disease (PD) (TEMPO-1)

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)

PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition

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.

A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease

Sponsor: Neuraly, Inc.

Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment With NLY01 in Early-stage Parkinson's Disease

Brief Summary: This is a phase 2 study designed to assess the safety, tolerability and efficacy of NLY01 in subjects with early untreated Parkinson's disease (PD).

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

Duration: 36 weeks

Basic Inclusion Criteria
1. Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic criteria or Movement Disorder Society Research Criteria
2. DaTscan consistent with diagnosis of Parkinson's Disease
3. Men or women 30 to 80 years of age

Exclusion Criteria:
1. Diagnosis of secondary or atypical parkinsonism
2. Prior use of dopaminergic treatment or MAO-B inhibitors for more than 28 days
3. Medical or recreational use of marijuana or THC-containing compounds within 3 months of screening visit
4. Pregnant or planning to become pregnant

Fixed-Dose Trial in Early Parkinson's Disease (PD) (TEMPO-1)

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)

PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition

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.

OFF-Time - time when the medication is not working to its full potential and symptoms are not well controlled. This can be predictable such as wearing off between doses when symptoms return at the end of one dose before the next dose is taken; or this can be unpredictable where medication suddenly loses its effect or when a particular dose of medication does not take effect.

A Clinical Trial Investigating the Efficacy, Safety and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless)

Sponsor: NeuroDerm Ltd.

Official title: A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Clinical Trial, Investigating the Efficacy, Safety, and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless)

Brief Summary: Eligible subjects will be enrolled to an open-label oral IR LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR LD/CD. Click here for more information.

Study design: Randomized, active-controlled, double-blind, double-dummy

Basic inclusion criteria
1. Male and female patients, aged ≥30 years.
2. PD diagnosis consistent with the UK Brain Bank Criteria.
3. Taking ≥4 levodopa doses/day (≥3 doses/day of Rytary) at a total daily dose of ≥400mg.

Exclusion Criteria:
1. Atypical or secondary parkinsonism.
2. Severe disabling dyskinesias.
3. Previous neurosurgery for PD.
4. Use of duodenal levodopa infusion (LCIG).
5. Use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks.
6. History of signi´Čücant skin conditions or disorders.


Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations (TEMPO-3)

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.

Remote Speech Study

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 


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

Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy

Sponsor: Addex Pharma S.A.

Official title: Phase 2b/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Dipraglurant (ADX48621) for the Treatment of Dyskinesia in Patients With Parkinson's Disease Receiving Levodopa-based Therapy

Brief Summary: This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia (randomized 1:1 to receive active or placebo) for 12 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day). The primary efficacy assessment will be based on the Unified Dyskinesia Rating Scale (UDysRS). Patients who complete the 12-week blinded treatment period may have the option to roll into an open-label safety extension study for an additional 12-month treatment period.

Study duration: 12 weeks

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

Basic inclusion criteria:

  • 30 to 85 years
  • Patients with Parkinson's Disease on a stable regimen of antiparkinson's medications, including a levodopa preparation administered not less than 3 times daily.
  • Meet protocol-specified criteria for moderate to severe dyskinesia symptoms based on UDysRS and MDS-UPDRS assessments.
  • Meet protocol specified criteria for ON time with troublesome dyskinesia based on a standard PD home diary.

Basic exclusion Criteria:

  • Prior surgical treatment for Parkinson's Disease (e.g., deep brain stimulation).
  • Other neurological disease (including psychiatric disease and/or cognitive impairment) that, in the opinion of the investigator, would affect the patient's ability to complete study assessments.
  • Other significant medical condition that may affect the safety of the patient or preclude adequate participation in the study.
  • Pregnant or breast-feeding. Female patients who are of child-bearing potential must be using adequate contraceptive methods (e.g. oral contraceptive, double-barrier method, intra-uterine device, intra-muscular hormonal contraceptive), and have a negative pregnancy test at Screening.
  • Other protocol-defined inclusion and exclusion criteria may apply

 


Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components (SHINE)

Sponsor: Bukwang Pharmaceutical

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

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.

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