Parkinson’s Disease & Movement Disorders Clinical Trials

Open Hart- Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease.

NCT01306929
Phase II

This open-label study is being conducted to assess the long-term safety and effectiveness of pridopidine 45 mg twice per day.

Description
Huntington disease (HD) is a hereditary neurodegenerative disorder causing impairment in movement, behavioral dysfunction and dementia. The movement disorder is mainly characterized by chorea (involuntary movements) and a progressive loss of voluntary movement causing a substantial functional impairment over time. The study will assess the long-term safety of pridopidine and the treatment effects during long-term, open-label treatment.

Not Enrolling

Who Can Participate? If you have successfully completed 12 weeks of pridopidine or placebo including the safety follow-up period in the HART trial you will be offered participation in the open-label extension study.

Investigator: Pinky Agarwal, MD

For More Information: Cherrie Sia - 425.899.3126 - CSia@evergreeenhealthcare.org

CREST-E

NCT00712426
Phase III

Description
Description-The purpose of CREST-E is to test whether high-dose creatine can slow the progressive functional decline that occurs in persons 18 years or older with early clinical features of HD over 3-years.

Currently Enrolling

Who Can Participate? Male / Female 18 or older, Clinical features of HD AND confirmatory family history of HD; OR CAG repeat expansion greater or equal to 36.

Investigator: Pinky Agarwal, MD

For More Information: Marsha Merrick - 425.899.5368 MGMerrick@evergreenhealthcare.org

A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease
(Study P05664)

NCT01155479
Phase III

This is a randomized, placebo- and active-controlled parallel-group, multi-center, double-blind trial of preladenant in adult subjects with early PD.

Description
The Primary Objective of this trial is to evaluate the efficacy of a range of preladenant doses compared with placebo in subjects with early Parkinson.s disease (PD).

Currently Enrolling

Who Can Participate?
Subjects with a diagnosis of idiopathic PD for less than 5 years will be
selected to participate in the study.

Investigator: Alida Griffith, MD

For More Information: Cherrie Sia 425.899.3126 csia@evergreenhealthcare.org

Droxidopa 304

NCT00782340
Phase III

A Multi-Center, One-Year Open-Label Study To Assess The Long-Term Safety Of Droxidopa In Subjects With Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency Or Non-Diabetic Neuropathy And Symptomatic Neurogenic Orthostatic Hypotension

Description
Evaluate the safety of droxidopa as measured by the occurrence of treatment-emergent adverse events and specific evaluations of blood pressure, heart rate, and laboratory findings across the study.

Not Enrolling

Investigator: Pinky Agarwal, MD

For More Information: Marsha Merrick 425.899.3115 MGMerrick@evergreenhealthcare.org

CD-PROBE

NCT00836017
Observational

CD PROBE - Cervical Dystonia - Patient Registry for Observation of BOTOX® Efficacy

Description
Multi-center, Prospective, Naturalistic, Observational Study of Cervical Dystonia and Therapy with BOTOX®

Currently Enrolling

Who Can Participate?
Diagnosis of Cervical Dystonia and either new to the physician's practice, new to botulinum toxin therapy,or if previously participated in botulinum toxin therapy, must not have received botulinum toxin for 16 or more weeks.

Investigator: Pinky Agarwal, MD

For More Information: Marsha Merrick 425.899.3115 MGMerrick@evergreenhealthcare.org

Duodopa 005

Not Enrolling

Phase III - Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies

Description
The primary objective is to provide continued access to subjects who would like to continue levodopa-carbidopa intestinal gel (LCIG), after completion of an open-label study (S187.3.003 or S187.3.004).

Investigator: Alida Griffith, MD

For More Information: Marsha Merrick 425.899.3115 MGMerrick@evergreenhealthcare.org

SP953

NCT01095484 - Not Enrolling

Phase IV Named patient program with Rotigotine transdermal system.

Description
The named patient program will allow investigators to continue to supply rotigotine transdermal system to patients who have a documented medical necessity to continue treatment with the drug.

Investigator: Alida Griffith, MD

For More Information: Cherrie Sia 425.899.3126 CSia@evergreenhealthcare.org

Adamas

Phase 2/3  Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)

Description
To evaluate the efficacy of three doses of study drug ADS-5102 oral capsules, an extended release formulation of amantadine, dosed once daily for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson’s disease (PD)

Enrolling subjects between the ages of 30-85 with levodopa-induced dyskinesia (LID) in subjects with Parkinson’s disease (PD)

Investigator:  Pinky Agarwal, MD

For More Information: Cherrie Sia @ 425-899-3126 or CSia@evergreenhealthcare.org

XCiDaBLE

XCiDaBLE - Cervical Dystoniaor Blepharospasm - Patient Registry for Observation of Xeomin® Efficacy. Treatment will be Observed and Documented.

Description  Prospective, observational trial evaluating Xeomin® (incobotulinumtoxinA) for cervical dystonia or blepharospasm in the United States.

Who Can Participate?
Prior treatment with a botulinum toxin for cervical dystonia or blepharospasm based upon physicians’ clinical experience.  Physician must have chosen to treat subject with Xeomin prior to and independent of enrollment in study.  Subjects must 18 years of age or older.

Investigator: Pinky Agarwal, MD

For More Information: Marsha Merrick 425.899.3115 MGMerrick@evergreenhealthcare.org

ANCHOR CD

Anchor cd - Cervical Dystonia - Patient Registry for Observation of Dysport™ Efficacy. |
To determine typical patient response to Dysport in the long-term (approximately one year) treatment of adult cervical dystonia (CD).

Description  DYSPORT for Injection AbobotulinumtoxinA Neurotoxin Clinical & Health Economics Outcomes Registry in Cervical Dystonia.

Who Can Participate?
Diagnosis of idiopathic Cervical Dystonia as determined by enrolling Investigator. If previously treated with a neurotoxin for CD, at least a 12 week interval must have elapsed between the last injection of BoNT-A or BoNT-B and the first dose of Dysport injected in this study.  Must be 18 years of age or older.

Investigator: Pinky Agarwal, MD

For More Information: Marsha Merrick 425.899.3115 MGMerrick@evergreenhealthcare.org