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 


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


CTC-002

A Phase 2 Study to evaluate the safety, tolerability and initial efficacy of pramipexole ER, given with aprepitant in patients with idiopathic Parkinson’s Disease.

Currently enrolling

Who may be eligible to participate?

  • Male or female subjects with idiopathic Parkinson’s disease (PD)
  • Age 40 to 80 years inclusive
  • PD severity in the Hoehn & Yahr 2 to 3 range
  • Currently not treated with pramipexole

What does participation involve?
Study participation will last up to 5 months and will include up to 10 study visits to the study center. In Part 1 of study participation, eligible subjects will switch from their pre-admission dopaminergic treatment to equivalent dose of pramipexole ER. In Part 2, pramipexole ER dose will be titrated up to maximum tolerated dose in combination with aprepitant. In Part 3, subjects will maintain the maximum tolerated dose of pramipexole ER found in Part 2 given in combination with aprepitant for 3 months with periodic safety and efficacy checks

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.


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


Subcutaneous Infusion Study for PD

A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of a study drug in subjects with Parkinson's disease.

Description
Booth Gardner Parkinson’s Care Center is conducting a study to test whether the study drug is safe and tolerable as a 24-hour continuous infusion in patients with Parkinson's disease (PD) over the course of 52 weeks. The study is also seeking to find out how well the study drug works to control Parkinson's disease symptoms.

Currently enrolling

Who may be eligible to participate?
Subjects 30 years of age and older with a confirmed diagnosis of levodopa-responsive idiopathic PD. Eligible subjects must also be taking a stable regimen of levodopa-containing oral medications for PD that has remained unchanged for at least 30 days. Other inclusion/exclusion criteria apply.

What does participation involve?
Participation in this study will involve subjects attending 13 study visits in the treatment period over 52 weeks. The study drug will be given as a 24-hour continuous subcutaneous (under the skin) infusion using an infusion pump.

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.


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


MOVES-PD

ClinicalTrials.gov Identifier: NCT02906020

Multicenter pharmacokinetics and interventional Study in Parkinson’s Disease

Description
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of GZ/SAR402671 in patients with early-stage Parkinson’s disease carrying a GBA mutation or other prespecified variant.

Currently enrolling

Who may be eligible to participate?
Subjects 18-80 years of age inclusive with a confirmed diagnosis of Parkinson’s disease (with at least two of the following signs: resting tremor, postural instability, akinesia/hypokinesia, and muscle rigidity) and who are heterozygous carriers of a GBA mutation.

What does participation involve?
The total study duration per subject in Part 2 will be approximately 168 weeks that will consist of 6.5 weeks of screening period, 52 weeks of treatment period, 104 weeks of follow-up period, and 6 weeks of post-treatment observation period.

Investigator: Alida Griffith, 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 with Memory Problem

PRESENCE (I7S-MC-HBEH)

Description
A randomized placebo-controlled trial in individuals with Parkinson's disease dementia to evaluate the safety and efficacy of three doses of a study drug in participants with mild-to-moderate Parkinson's disease dementia treated for 12 weeks.

Currently enrolling

Who may be eligible to participate?
Subjects 40-85 years of age who meet diagnostic criteria for idiopathic Parkinson’s disease (PD) with at least 2 years of PD symptoms may be eligible. Participants must also have dementia as defined by a decline in cognitive function, which in the opinion of the investigator has resulted in functional impairment.

What does participation involve?
Subjects will be seen for approximately 12 visits over a period of up to 17-18 weeks. Additional visits may be necessary for unscheduled assessments due to adverse events (AEs).

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 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, FAANBooth 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, MDBooth Gardner Parkinson’s Care Center

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


CTH-301

ClinicalTrials.gov Identifier: NCT02542696

Does your Parkinson’s disease medication take too long to work?
Does your Parkinson’s disease medication not last until the next scheduled dose?
Does your Parkinson’s disease medication suddenly stop working?
Is your Parkinson’s disease medication unreliable?

If you answered yes to any of these questions, you may be eligible to participate in a study evaluating an investigational drug to see if it could effectively and quickly turn you from the OFF state to the ON state.

Eligible study participants will continue taking their current Parkinson’s disease medications.

All study-related visits, tests, and medication will be provided to participants at no cost. In addition, reimbursement for study-related time and travel may be provided.

To learn more about this study, please contact the Booth Gardner Parkinson’s Care Center study team today.

Investigator: Alida Griffith, MDBooth Gardner Parkinson’s Care Center

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