Parkinson’s Disease & Movement Disorders Clinical Trials

EvergreenHealth Research is part of a large PD consortium through the National Institutes of Health.

Parkinson Study Group:  The largest not-for-profit scientific network of credentialed Parkinson Centers comprised of experienced investigators and coordinators from academic/research institutions in North America. Research is conducted to find new treatment for PD, as well as new ways to diagnose PD and related neurological disorders. PSG trial sites are selected on the basis of their experience and performance in conducting clinical research studies in Parkinson's disease.

Listen to Dr. Pinky Agarwal's interview about Parkinson's research at EvergreenHealth:

Interview part one
Interview part two 


TEMPO-3

Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson’s Disease With Motor Fluctuations (CVL-751-PD-003)

Description
The Booth Gardner Parkinson’s Care Center is conducting a phase 3, double-blind, placebo-controlled, 27-week trial to evaluate the efficacy, safety, and tolerability of tavapadon as adjunctive therapy for Parkinson’s disease in levodopa-treated adults with motor fluctuations.

Currently enrolling

Who may be eligible to participate?
Male or female patients, age 40 to 80 years (inclusive) who have been diagnosed with Parkinson’s disease (PD) with bradykinesia and motor asymmetry. Other inclusion/exclusion criteria apply.

What does participation involve?
Each subject will participate in the trial for up to approximately 35 weeks, including screening (up to 4 weeks), treatment (27 weeks), and post-treatment safety follow up (4 weeks). Subjects who complete through Week 27 of the trial may have the opportunity to enter into an open-label extension trial.

Investigator: Daniel Burdick, MD, Booth Gardner Parkinson’s Care Center

For more information: contact the EvergreenHealth Research Services hotline at 425.899.5385 or email EvergreenResearch@evergreenhealth.com.


TEMPO-2

Flexible-Dose Trial of Tavapadon in Early Parkinson’s Disease (CVL-751-PD-002)

Description
The Booth Gardner Parkinson’s Care Center is conducting a phase 3, double-blind, placebo-controlled study to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of flexible doses of tavapadon in participants with Parkinson's Disease.

Currently enrolling

Who may be eligible to participate?
Male or female patients, age 40 to 80 years (inclusive) who have been diagnosed with Parkinson’s disease (PD) within 3 years of the screening visit. Other inclusion/exclusion criteria apply.

What does participation involve?
Subjects will be randomized to receive either tavapadon or placebo, once daily. The trial will include a Screening Period (maximum of 4 weeks), a 27-week Treatment Period, a 10-day Safety/Withdrawal Assessment Period, and a 20-day Safety Follow-up Period. Each subject will participate in the study for up to approximately 35 weeks.

Investigator: Daniel Burdick, MD, Booth Gardner Parkinson’s Care Center

For more information: contact the EvergreenHealth Research Services hotline at 425.899.5385 or email EvergreenResearch@evergreenhealth.com.

PRISM PD Study (NLY01-PD-1)

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

Description
Booth Gardner Parkinson’s Care Center is conducting a study to determine the effectiveness of a study drug relative to placebo in patients with Parkinson’s disease (PD). Study drug or placebo will be given as a weekly subcutaneous injection over 36 weeks.

Currently enrolling

Who may be eligible to participate?
Subjects 30 to 80 years of age (inclusive) with a confirmed diagnosis of PD. Onset of any parkinsonian motor sign or symptom must be within 5 years before the Screening Visit. Other inclusion/exclusion criteria apply.

What does participation involve?
Participation in this study will involve subjects attending 10 in-person study visits. After instruction, subjects will self-administer the study drug subcutaneously once per week for 36 weeks (36 doses) with safety follow-up visits approximately 4 weeks and 8 weeks after last injection.

Investigator: Daniel Burdick, MD, Booth Gardner Parkinson’s Care Center

For more information: contact the EvergreenHealth Research Services hotline at 425.899.5385 or email EvergreenResearch@evergreenhealth.com.


KARMET

Investigational Drug Study for Patients with Parkinson’s Disease-Related Constipation

Description
Booth Gardner Parkinson’s Care Center is conducting a study to evaluate the safety, tolerability, and effectiveness of repeated oral doses of an investigational drug for up to 25 days in patients with Parkinson’s Disease-related constipation.

Currently enrolling

Who may be eligible to participate?
Subjects 30-to-90 years of age with a diagnosis of Parkinson's Disease (defined as the presence of at least three of the following cardinal features: rest tremor, rigidity, bradykinesia and/or akinesia, postural and gait abnormalities) and constipation (which has been present for over 6 months and is unresponsive to first line, typically over the counter treatments). Other inclusion/exclusion criteria apply.

What does participation involve?
The study will be conducted on an outpatient basis. Patients will be randomized 1:1 to treatment or placebo.

Each patient will have six visits to the clinic:

  • a screening visit
  • a randomization visit
  • three follow up visits
  • one end of study visit

Investigator: Daniel Burdick, MD, Booth Gardner Parkinson’s Care Center

For more information: contact the EvergreenHealth Research Services hotline at 425.899.5385 or email EvergreenResearch@evergreenhealth.com.


ROPAD

Rostock International Parkinson’s Disease Study - An international, multicentre, epidemiological observational study

Description
Parkinson’s disease (PD) is mostly considered an idiopathic disease, however more and more data suggest that it is a disease that involves interaction of genetic and environmental factors. The most common monogenic form and the one most closely resembling idiopathic PD is LRRK2 (Leucine-rich repeat kinase 2 gene) associated PD. This research study aims to identify LRRK2-positive patients, non-LRRK2 PD patients (including a subset of patients with monogenic PD other than LRRK2) and to establish a biomarker in the LRRK2-positive cohort.

Currently enrolling

Who may be eligible to participate?
Men and women 18 years of age and older who are clinically diagnosed with Parkinson‘s disease or is a family member of a patient with LRRK2 parkinsonism or is a member of a high risk population with an early PD onset. Other inclusion and exclusion criteria may apply.

What does participation involve?
Qualified subjects will participate in one study visit that will last approximately one hour. One blood sample (approximately 1 mL) will be taken and a neurological examination will take place.

Investigator: Pinky Agarwal, MD, FAAN, Booth Gardner Parkinson’s Care Center

For more information: contact EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@evergreenhealth.com


Placebo-Controlled Study for Early PD

PROSEEK: A Phase 2 Study in Early Parkinson's Disease Patients Evaluating the Safety and Effectiveness of Abl Tyrosine Kinase Inhibition Using K0706

Description
This study will determine if an investigational drug reduces the rate of progression of early-stage Parkinson’s disease (PD) versus placebo over 40 weeks.

Currently enrolling

Who may be eligible to participate?
Males or females 50 years of age and above, with a diagnosis of PD with symptoms beginning in the past three years and who are not on any dopaminergic treatment. Other inclusion and exclusion criteria may apply.

What does participation involve?
This study will have 11 study visits over a period of about 44 weeks, not including the Screening Visit. Screening assessments will be performed over a period of up to 6 weeks during the “Screening Period”. Subjects who qualify for this study will be randomly assigned to receive either 96mg of investigational study drug, 192mg of investigational study drug, or placebo (no drug) capsules.

Investigator: Pinky Agarwal, MD, FAAN, Booth Gardner Parkinson’s Care Center

For more information: contact EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@evergreenhealth.com


Parkinson's Disease Patients With Motor Fluctuations

ClinicalTrials.gov Identifier: NCT03670953

IPX203-B16-02: A Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study to evaluate the safety and efficacy of the investigational product IPX203 (carbidopa and levodopa or “CD-LD”) extended-release (ER) capsules in comparison to immediate release (IR) CD-LD in Parkinson's disease (PD) subjects who have motor fluctuations. The study includes 7 visits to the study center during approximately 24 weeks.

Currently enrolling

Who may be eligible to participate?
Male or female subjects diagnosed with PD at age ≥40 years who are currently being treated with a stable regimen of CD-LD but are experiencing motor fluctuations. Patients must experience an average of at least 2.5 cumulative hours per day of “Off” time during waking hours to qualify.

Investigator: Daniel Burdick, MD, Booth Gardner Parkinson’s Care Center

For more information: contact EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@evergreenhealth.com


Recently Diagnosed with Parkinson's Disease

ClinicalTrials.gov Identifier: NCT03329508

A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER

Description
This study is planned to see how effective and how safe a new investigational medication named P2B001 is in 525 adults in North America and Europe with early Parkinson’s disease. All subjects receive an active study treatment, one of four that are being compared. There is no placebo arm in the study.

Currently enrolling

Who may be eligible to participate?
Subjects who were recently diagnosed with Parkinson's disease, are between the ages 35 and 75 and have not been taking other Parkinson’s disease medication for more than 4 weeks.

What does participation involve?
The study includes 7 visits to the study center during approximately 14 to 18 weeks. The study involves taking study medications once-daily for 13 weeks. The study team will be monitoring subjects’ condition and will be available for subjects if they have any questions. Subjects will be asked to attend all scheduled visits, follow the study doctor’s instructions and take study drugs as directed; to not participate in any other clinical trials, while participating in this study and to inform the study doctor of any changes in their health or medication, whether or not they think they are related to the study drugs.

Investigator: Daniel Burdick, MD, Booth Gardner Parkinson’s Care Center

For more information: contact EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@evergreenhealth.com


Parkinson’s Disease with Insomnia

Suvorexant IIT

Phase IV - A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Suvorexant for Insomnia in Parkinson Disease

Description
This study uses a crossover design, which means that it’s divided into two treatment periods in which subjects will receive the drug suvorexant for half of the study and placebo the other half. The study will last for approximately 11-15 weeks.

Who may be eligible to participate?
Subjects aged 30-80 years old. Diagnosed with Parkinson’s disease and have insomnia. Subjects will be asked to make 5 scheduled visits to the study office and undergo 3 overnight sleep studies, as well as scheduling 4-6 phone calls. Must have a stable Parkinson’s medication regimen for 4 weeks prior to visit 1 and remain on a stable regimen for the duration of the study.

Investigators: Daniel Burdick, MD and Pinky Agarwal, MD, FAAN, Booth Gardner Parkinson’s Care Center

For more information: contact EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@evergreenhealth.com


RESTORE

A Clinical Study of Patients with Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy.

ClinicalTrials.gov Identifier: NCT02586623

Who may be eligible to participate?
Male and female subjects aged 18 years and older. Must be able to stand (with or without assistance). Clinical diagnosis of symptomatic orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA or PAF) or NDAN or DBH Deficiency.

Investigator: Alida Griffith, MD, Booth Gardner Parkinson’s Care Center

For more information: contact EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@evergreenhealth.com

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