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 


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: Jana Akture - 425.899.5393 / CAkture@evergreenhealth.com 


Lightheadness/Dizziness with PD

CLIN301-101: A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CERC-301 in Patients with Symptomatic Neurogenic Orthostatic Hypotension (nOH) associated with Parkinson's Disease

Description
This study will assess the safety, tolerability, and pharmacokinetics of single and multiple doses of an investigational study drug in adults with symptomatic Neurogenic Orthostatic Hypotension (nOH) associated with Parkinson's disease.

Currently enrolling

Who may be eligible to participate?
Subjects 18 years of age and older with a clinical diagnosis of symptomatic nOH associated with Parkinson’s disease may be eligible. Subjects must have persistent symptoms of nOH for 14 days prior to screening and must not be taking anti-hypertensive medications or droxidopa. Other inclusion and exclusion criteria may apply.

What does participation involve?
Subjects will be dosed on five separate occasions, approximately 7-10 days apart, with one of four single escalating doses of study drug or placebo and undergo an orthostatic challenge test to assess the safety, tolerability, and effect on blood pressure and pharmacokinetics. Subjects will also complete an nOH symptomatic assessment following the orthostatic challenge. Participation is expected to last up to 10 weeks.

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

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


Adults with Parkinson’s Disease and Inadequately Controlled Depression

An Open-label, 8-Week Study of Safety and Efficacy for Adjunctive Pimavanserin Treatment in Adults with Parkinson’s Disease and Inadequately Controlled Depression

Description
This study will assess the effectiveness of pimavanserin when given along with a selective serotonin reuptake inhibitor/selective norepinephrine reuptake inhibitor (SSRI/SNRI) for depression in adults with Parkinson’s disease.

Currently enrolling

Who may be eligible to participate?
Subjects 50 years of age and older with a clinical diagnosis of Parkinson’s disease within 1 year prior to screening may be eligible. Subjects must also meet clinical criteria for depression with Parkinson’s disease and be taking an SSRI or SNRI antidepressant permitted by the study protocol. Other inclusion and exclusion criteria may apply.

What does participation involve?
Enrolled subjects will be instructed to take pimavanserin 34 mg (provided as two 17 mg tablets) orally once daily. The total duration of study participation for each subject will be up to 13 weeks, consisting of a screening period of up to 3 weeks, followed by a treatment period of approximately 8 weeks, and a 2-week safety follow-up.

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

For More Information: Shalom Kilcup - 425.899.5369 / SEKilcup@evergreenhealth.com 


Neuroprotective Trial Therapy for Parkinson’s Disease

SPARK 228PD201

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease.

Description
This study will evaluate the dose-related safety, pharmacokinetics, and pharmacodynamics of BIIB054, administered every 4 weeks via IV infusion to adult subjects with Parkinson’s disease.

Currently enrolling

Who may be eligible to participate?
Subjects 40-80 years of age with a confirmed diagnosis of Parkinson’s disease within 3 years prior to screening. Subjects must also have an asymmetric or bilateral presentation of one of the following: resting tremor and bradykinesia; bradykinesia and rigidity; rigidity and resting tremor OR either asymmetric resting tremor or asymmetric bradykinesia. Subjects must also have not received levodopa or any other treatment for PD for at least 12 weeks prior to randomization.

What does participation involve?
All subjects in the study will be randomized into 4 arms, to receive 25 doses of BIIB054 (250, 1250, or 3500 mg) or placebo. The total duration of study participation for each subject will be up to approximately 113 weeks, including a 5-week Screening period before the first study infusion, a 48-week placebo-controlled dosing period, a 48-week active dose-blinded period, and a 12-week follow-up period.

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

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


Botanical Plant-based Investigational Drug Product for Early Parkinson`s Disease

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, FAANBooth Gardner Parkinson’s Care Center

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


Implantable Medication for Parkinson’s Disease

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, FAANBooth Gardner Parkinson’s Care Center

For More Information: Anna Fierro - 425.899.5387 / amfierro@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: Gowri Rajendran – 425.899.5370 / GRajendran@evergreenhealth.com 


Accordian Pill

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 investigational 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 age 30 years and older, diagnosed with idiopathic Parkinson’s disease. Subjects must be taking at least 4 doses of levodopa containing medication per day (for a total daily dose of 400 mg to 1300 mg) with at least 2.5 hours "Off time" per day on average.

Investigator: Daniel Burdick, MDBooth Gardner Parkinson’s Care Center

For More Information: Carey Gonzales - 425.899.5374 / CLGonzales@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: Marsha Merrick - 425.899.3115  MGMerrick@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

Contact: Marsha Merrick - 425.899.3115 / mgmerrick@evergreenhealth.com 

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