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 


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: Jana Akture - 425.899.5393 / CAkture@evergreenhealth.com 


DA-9805-PD-001

A Phase IIa, Randomized, Multicenter, Double-Blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Efficacy of DA-9805 in Subjects with Parkinson’s Disease

Description
This is a phase IIa, first in human, randomized, double-blind, multicenter study to evaluate the safety and tolerability of DA-9805 (the study drug) compared to placebo in subjects with Parkinson’s Disease.

Currently enrolling

Who may be eligible to participate?
Subjects 30-79 years of age with a confirmed diagnosis of Parkinson’s disease within 2 years prior to screening. Eligible subjects who are newly diagnosed may not currently be on any Parkinson’s disease medication or subjects may be on stable doses of Amantadine or anticholinergics for treatment of Parkinson’s disease for at least 4 weeks prior to screening.

What does participation involve?
Subjects will be asked to attend a screening visit to determine eligibility, 4 in-clinic visits during the 12-week double-blind study treatment phase, and a follow-up visit 4 weeks after study treatment has ended.

Investigator: Pinky Agarwal, MD, FAAN

For More Information: Gowri Rajendran - 425.899.5370 / grajendran@evergreenhealth.com 


ROP-001

An Open-Label, Relative Bioavailability Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ropinirole Implants in Patients with Parkinson’s Disease Switched from Oral Immediate-Release Ropinirole While on L-Dopa

Description
Subjects stable on L-Dopa and oral ropinirole will have their ropinirole replaced with the Ropinirole Implant(s). The Ropinirole Implant was designed using the ProNeura™ implant technology where the implant is inserted under the skin. This study will measure how much ropinirole is released in the blood during 3 months of dosing, and evaluate the side effects of this new formulation.

Currently enrolling

Who may be eligible to participate?
Subjects 30-80 years of age who meet diagnostic criteria for idiopathic Parkinson’s disease (PD) and the UK Brain Bank Criteria may be eligible. Subjects must be on a fixed dose of L-Dopa and a fixed dose of ropinirole immediate-release or ropinirole extended-release) for at least 30 days, and have their PD deemed clinically stable and at baseline for at least 2 weeks immediately prior to the Screening Visit.

What does participation involve?
Subjects will be seen for approximately 18 visits over a period of up to 17.5-19.5 weeks. Additional visits may be necessary for unscheduled assessments due to adverse events (AEs).

Investigator: Pinky Agarwal, MD, FAAN

For More Information: Anna Fierro - 425.899.5387 / amfierro@evergreenhealth.com  


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: Gowri Rajendran – 425.899.5370 / GRajendran@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: Gowri Rajendran – 425.899.5370 / GRajendran@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 


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

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


PASSAGE

Do you have Parkinson’s disease and is excessive sleepiness slowing you down?

The PASSAGE Study is looking at an investigational medication for patients with Parkinson’s disease who are very sleepy during the day. The study will look at whether the investigational medication can help patients feel more awake and alert throughout the day. It will also look at how safe the investigational medication is.

Would you like to take part?
You may be able to take part in the PASSAGE Study if you:

  • are between 35 and 80 years of age
  • have a diagnosis of Parkinson’s disease
  • experience unusual daytime sleepiness, despite spending 6 or more hours in bed.

Investigator: Alida Griffith, MD

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

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