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.

Currently 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

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Duodopa 002

NCT00660387
Phase III - A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations

Diagnoses of advanced Parkinson's disease (PD)

Description
The primary objective of this study will be to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.The study duration is 4 months. The experimental drug is levodopa-carbidopa intestinal get and the experimental delivery system includes a pump and tubing.

Currently Enrolling

Who Can Participate? 30 years and older, diagnosed with advanced Parkinson's disease.

Investigator: Alida Griffith, MD

For More Information: Marsha Merrick 425.899.3115 mgmerrick@evergreeenhealthcare.org

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CREST-E

NCT00712426
Phase III

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: Cynthia Mendenhall 425.899.5368 cdmendenhall@evergreenhealthcare.org

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COHORT

NCT00313495
Observational Trial for individuals who are affected by Huntington disease.

Description
The purpose of this study is to collect prospective data from individuals who are part of a Huntington Disease (HD) family, in order to relate phenotypes between individuals and families with each other and genetic factors in order to learn more about HD, develop potential treatments for HD, and to plan for future research studies of experimental drugs aimed at slowing or postponing the onset and progression of HD.

No Longer Enrolling

Who Can Participate? Subjects will either have the signs and symptoms of Huntington Disease (HD) or be a member of an HD family.

Investigator: Pinky Agarwal, MD

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

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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

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QE3

NCT00740714
Phase III - Effects of Coenzyme Q10 on Early Parkinson Disease

Description
To compare with placebo the effect of two dosages of CoQ on the total score on the Unified Parkinson Disease Rating Scale (UPDRS) in subjects with early Parkinson disease.

Not Enrolling

Investigator: Pinky Agarwal, MD

For More Information: Bari Dorward 425.899.5370 BJDorward@evergreenhealthcare.org

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Droxidopa 301

NCT00782340
Phase III - A Multi-Center, Double-Blind, Randomized, Placebocontrolled, Parallel-Group Induction-Design Study To Assess The Clinical Effect Of Droxidopa In Subjects With Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency Or Non-Diabetic Neuropathy And Symptomatic Neurogenic Orthostatic Hypotension.

Description
Study to evaluate the efficacy of droxidopa in patients with symptomatic Neurogenic Orthostatic Hypotension

Not Enrolling

Investigator: Alida Griffith, MD

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

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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

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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

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Duodopa004

NCT00335153
Phase III - Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuation

Description
The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 6-12-months in subjects with advanced Parkinson's Disease (PD) and severe motor-fluctuations who have not had optimal response to oral levodopa-carbidopa treatment. Additional supportive evidence for efficacy will be assessed in the treatment of severe motor-fluctuations, dyskinesia and mobility.

Not Enrolling

Investigator: Alida Griffith, MD

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

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Duodopa 005

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).

Not Enrolling

Investigator: Alida Griffith, MD

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

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SP921

NCT00522379
Phase III - A Multicenter, Randomized, Double-Blind,Placebo-Controlled, 5-Arm, Parallel-Group Trial To Assess Rotigotine Transdermal System Dose Response In Subjects With Advanced-Stage Parkinson's Disease

Description
The primary objective of this trial is to show rotigotine dose response (at 2, 4, 6, or 8mg/24h) in subjects with advanced-stage Parkinson's disease. A secondary objective is to demonstrate the safety and tolerability of rotigotine at these doses.

Not Enrolling

Investigator: Alida Griffith, MD

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

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SP953

NCT01095484
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

Currently Enrolling

Investigator: Alida Griffith, MD

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

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HART

NCT00724048
Phase IIb/III - A multi-center, North American, randomized, double-blind, parallel group study comparing three doses of ACR16 versus placebo for the symptomatic treatment of Huntington Disease

Description
Assess the effects of ACR16 on voluntary motor function in HD subjects.

Not Enrolling

Investigator: Pinky Agarwal, MD

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