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 


MAESTRO

ClinicalTrials.gov Identifier: NCT02092181

Phase IV - A Pilot Study of Mirabegron and Behavioral Modification including Pelvic Floor Exercise for Overactive Bladder in Parkinson Disease

Description
This study is a randomized 1:1 placebo-controlled 10-week study of Mirabegron as add-on therapy to an educational intervention of behavioral modification including pelvic floor exercise (PFE) in a cohort of 40 PD subjects with overactive bladder (OAB).

Who can participate?
Subjects ages 30 years and older diagnosed with Parkinson’s disease and overactive bladder. Must be willing to attend 4 scheduled visits to study office and 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

For More Information: Carey Gonzales - 425.899.5374  CLGonzales@evergreenhealth.com


TOZ-PD

ClinicalTrials.gov Identifier: NCT02453386

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Phase to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose "Wearing-Off" (TOZ-PD)

Description
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study with an open-label phase to determine the efficacy and safety of Tozadenant as adjunctive therapy in levodopa-treated patients with Parkinson's disease experiencing end of dose "wearing-off". The drug being studied is called tozadenant and it is believed to act on parts of the brain where dopamine controls movement. Tozadenant has also been called SYN115.

Who may be eligible to participate?
Patients aged 30 to 80 years with minimum of 3 years since Parkinson’s disease diagnosis. Patients with secondary or atypical Parkinsonism may be excluded from participating.

Investigator: Alida Griffith, MD

For More Information: Marsha Merrick - 425.899.3115 MGMerrick@evergreenhealth.com


INFUSION

ClinicalTrials.gov Identifier: NCT02339064

A Phase 3, Open-Label Study of the Safety, Efficacy and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson's Disease Patients With Unsatisfactory Control on Available

Description
This is a Phase 3, multicenter, open-label, safety and efficacy study of continuous infusion apomorphine in subjects with advanced Parkinson's Disease (PD) who are unable to achieve adequate control despite optimized noninvasive therapy.

Who may be eligible to participate?
Subjects age 30 to 80 years with advanced idiopathic Parkinson’s disease who experienced “off” period averaging 3 hours per waking day. Subjects may not have history of deep brain stimulation (DBS).

Investigator: Pinky Agarwal, MD, FAAN

For More Information: Carey Gonzales - 425.899.5374 CLGonzales@evergreenhealth.com


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

For More Information: Carey Gonzales - 425.899.5374 clgonzales@evergreenhealth.com 


IN 11 004

Phase III - A Study to Assess the Efficacy and Safety of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients (Accordance)

Description
The purpose of this study is to determine whether the gastric retentive Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) is more effective than the commercially available immediate release Carbidopa/Levodopa in reducing motor fluctuations such as "off time" in advanced Parkinson's disease patients.

Who may be eligible to participate?
Subjects aged 35-85 years old, diagnosed with idiopathic Parkinson’s disease. Subjects must be taking at least 4 doses of levodopa containing medication per day with at least 2.5 hours "Off time" per day on average.

Investigator: Daniel Burdick, MD

For More Information: Marsha Merrick - 425.899.3115  MGMerrick@evergreenhealth.com 


BOLD MRI

Phase IV - Investigating Central Mechanisms of Overactive Bladder in Adults with Parkinson’s Disease.

Clinicaltrials.gov identifier: NCT02783014

Description
This study will consist of two in-clinic visits, and planned enrollment will be 10 adults with Parkinson’s disease (PD) and overactive bladder (OAB), and 10 adults with PD only. Subjects will undergo functional magnetic resonance imaging (fMRI) at the second study visit. The length of participation in this study is approximately 4 weeks.

Who may be eligible to participate?
Subjects aged 30 years and older. Diagnosed with Parkinson’s disease with and without overactive bladder. Subjects will be asked to make 2 scheduled study visits and undergo 1 fMRI. Must remain on a stable Parkinson’s medication regimen for the duration of the study.

Investigators: Pinky Agarwal, MD, FAAN and Daniel Burdick, MD

For More Information: Jana Akture - 425.899.5393 CAkture@evergreenhealth.com 


If you or a loved one currently experience motor fluctuations due to Parkinson’s disease, you may want to talk to your doctor about a clinical study of an investigational medication for Parkinson’s disease.

The purpose of this study is to evaluate the efficacy and safety of an investigational medicine in Parkinson's disease patients who experience motor-fluctuations.

Participants in the study may receive either the investigational drug or a placebo. Qualified individuals will participate in the study for approximately 23 weeks, including 13 clinic and 4 phone visits.

Who may be eligible to participate?

  • Age 45 to 85 years with clinical diagnosis of Parkinson’s disease
  • On a daily dose of at least 400 mg of L-Dopa
  • Experience motor fluctuations and are able to recognize “wearing off” symptoms
  • Must not have a history of surgical intervention for Parkinson’s disease or atypical Parkinsonian syndrome

Investigators: Pinky Agarwal, MD, FAAN

For More Information: Anna Fierro, CMA, CCRC – 425.899.5387 AMFierro@evergreenhealth.com 
Or visit https://clinicaltrials.gov/ct2/show/NCT02687542 


CTH-300

ClinicalTrials.gov Identifier: NCT02469090

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients with Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

Description
A 12-week, prospective, multi-center, randomized, double-blind, placebo controlled, Phase 3 study in L-Dopa responsive PD patients with motor fluctuations ("OFF" episodes), designed to determine the efficacy, safety and tolerability of APL-130277. APL-130277 is a fast-acting thin film formulation of apomorphine (APOKYN®) that is placed under the tongue and is intended to be an alternative to the injectable form of apomorphine. Study participation will take approximately 110-135 days (consisting of up to 13 clinic visits, including the Screening and Follow-up Visits, and an at-home treatment period).

Currently enrolling

Who may be eligible to participate?
Patients aged 18 years and older with clinical diagnosis of idiopathic Parkinson’s disease. Patients must be receiving stable doses of L-Dopa/carbidopa (immediate or CR) administered at least 4 times per day OR Rytary™ administered 3 times per day, for at least 4 weeks before the initial Screening Visit. Patients with secondary or atypical Parkinsonism may be excluded from participating.

Investigator: Alida Griffith, MD

For More Information: Marsha Merrick - 425.899.3115 MGMerrick@evergreenhealth.com 


CTH-301

ClinicalTrials.gov Identifier: NCT02542696

A 24-week, prospective, multi-center, open-label, Phase 3 study in L-Dopa responsive PD patients with motor fluctuations ("OFF" episodes), designed to evaluate the long-term safety, tolerability and efficacy of APL-130277.

Who may be eligible to participate?
Male and female subjects aged 18 years and older. Clinical Diagnosis of idiopathic Parkinson’s disease. Must be receiving stable doses of L-Dopa/carbidopa (immediate or chronic release) administered at least 4 times per day OR Rytary™ administered 3 times per day, for at least 4 weeks before the initial Screening Visit. Subjects with atypical or secondary Parkinsonism are not eligible.

Investigator: Alida Griffith, MD

For More Information: Marsha Merrick - 425.899.3115 MGMerrick@evergreenhealth.com 

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