Parkinson’s Disease 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 


M19-304

A Randomized, Double-Blind, Placebo Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of an investigational drug in Patients with Parkinson's Disease

Description
Booth Gardner Parkinson’s Care Center is conducting a study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of an investigational drug with multiple ascending doses, administered every 28 days via intravenous (IV) infusions in subjects with Parkinson’s Disease (PD).

Currently enrolling

Who may be eligible to participate?
Male and female subjects ≤ 85 years of age at the time of Screening with diagnosis of idiopathic PD within the past 5 years. Other inclusion/exclusion criteria apply.

What does participation involve?
Eligible subjects will be randomly assigned to receive a total of four doses of investigational drug or matching placebo. The doses in all groups will be administered every 28 days by IV infusion, over a course of 16 weeks. Participation is estimated to last up to 43 weeks, which includes a Screening Period, Treatment Period, and Follow-up Period.

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.


FIRE-UP PD

Fostering Inclusivity in Research Engagement for Underrepresented Populations in Parkinson’s Disease

Description
This study seeks to address the knowledge gaps in Parkinson’s disease (PD) and PD research and to increase enrollment of underrepresented groups (URG) in the online Fox Insight study through randomized pairs of intervention and control sites.

Currently enrolling

Who may be eligible to participate?
Male and female subjects 18 years of age and older with diagnosis of Parkinson’s disease or related movement disorder. Caregivers of affected patients may also be eligible to participate.

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

GRANT: EvergreenHealth was awarded a $10,000 grant from the Michael J. Fox Foundation (MJFF) for Parkinson's Research. Read about the grant >


0169

A Phase 3 Clinical Effect Study of TD-9855 for Treating Symptomatic Neurogenic Orthostatic Hypotension (snOH) in Subjects with Primary Autonomic Failure

Description
This 4-week placebo-controlled study is intended to evaluate the effectiveness of an investigational drug (TD-9855) in subjects with multiple system atrophy (MSA), Parkinson’s disease (PD), or pure autonomic failure (PAF) who are experiencing symptomatic neurogenic orthostatic hypotension (snOH) compared with placebo.

Currently enrolling

Who may be eligible to participate?
Subjects 30 years of age and older with a confirmed diagnosis of snOH due to MSA, PD, or PAF. Other inclusion and exclusion criteria may apply.

What does participation involve?
The total study duration per subject is approximately 9 weeks. After a 3-week screening period, subjects will be randomized to receive either TD-9855 or matching placebo once daily for the next 4 weeks.

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

For More Information: contact the EvergreenHealth Research Services main line at 425.899.5385 or email EvergreenResearch@evergreenhealth.com.


0170

A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD?9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure

Description
This randomized withdrawal study aims to evaluate the sustained benefit in effectiveness and safety of ampreloxetine in subjects with primary autonomic failures (MSA, PD, or PAF) and snOH.

Currently enrolling

Who may be eligible to participate?
Subjects 30 years of age and older with a confirmed diagnosis of snOH due to MSA, PD, or PAF. Other inclusion and exclusion criteria may apply.

What does participation involve?
The total study duration per subject is approximately 22-24 weeks. The study consists of 3 periods: (i) 16-week open-label (OL) study treatment with ampreloxetine, (ii) 6-week randomized placebo-controlled study treatment, and (iii) 2-week follow-up [only for subjects who do not enroll in Study 0171 (long-term extension safety study)].

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

For More Information: contact the EvergreenHealth Research Services main line 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


Adults with Parkinson’s disease and Levodopa-Induced Dyskinesia

A 14-Week, Double-Blind, 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 (gLIDe)

Description
This study will evaluate the effectiveness of 2 dosages of pridopidine vs placebo for the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease (PD-LID).

Currently enrolling

Who may be eligible to participate?
Male or female patients 30 to 85 years of age, inclusive, with Parkinson’s disease (PD) diagnosis and documentation of mild-to-moderate Levodopa-Induced Dyskinesia (LID) may be eligible. Other inclusion and exclusion criteria will be assessed during an office visit.

What does participation involve?
Eligible subjects will be asked to make a total of 8 visits to the study site over 19 weeks; each visit will take approximately 4-6 hours. Subjects will be randomly assigned (like the flip of a coin) to either study medication or placebo.

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


Dietary Extract Study on GI Tolerability and Gut Microbiome for Patients with PD

Description
Booth Gardner Parkinson’s Care Center is conducting a food safety and tolerability study to assess the safety of the dietary ingredient AB-4166 for the dietary management of the microbiome, which may support gastrointestinal function in individuals who have an elevated level of certain bacteria in their stool and who have Parkinson’s Disease (PD).

Currently enrolling

Who may be eligible to participate?
Subjects 30 to 85 years of age (inclusive) with a confirmed diagnosis of PD may be eligible. Other inclusion/exclusion criteria apply.

What does participation involve?
This study is comprised of four periods: Screening; Low Consumption Level Period; High Consumption Maintenance Level Period; and a Follow-Up Period. Study participants will visit the study site up to 7 times over a maximum duration of 32 weeks (including Screening and Follow-Up visits).

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 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