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Medical advancements and improvements in how doctors treat disease are made possible by what we learn through clinical trials. Commonly done in a medical setting such as a hospital, clinical trials are research studies that evaluate the safety and effectiveness of new treatments, whether they are drugs, devices, or preventative and other therapeutic measures that can influence health. Patients who participate in clinical trials have the opportunity to access treatments before they are publically available and also help others by contributing to medical research.  

Atlantic Health System hospitals participate in numerous clinical trials in partnership with other research organizations and pharmaceutical or biotech sponsors. Please browse the listing of clinical trials below to learn more about our open and active studies. Our physicians are committed to finding the latest treatments within a variety of medical areas, with a particular focus on cancer, genetics and congenital disease, movement disorders such as Parkinson’s disease, pediatrics, valve disease, and women’s health. 

Showing 5 Results for Parkinson's Disease

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Parkinson's Disease
Open to Enrollment

A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias

Amantadine has been used for many years as a treatment for Parkinson's disease. It has been reported in the literature to effectively treat the motor complications of levodopa, especially dyskinesia, but it must be given 2 to 4 times a day. The purpose of...

Investigator:
Marcie Rabin, MD

this multi-center, randomized, double-blind, parallel-group, 16 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease. The dose will be given once a day in the morning so that amantadine concentrations are maintained throughout the day for treating the levodopa induced dyskinesia, but will be lower during the night, potentially reducing the negative impact of amantadine on sleep.

OS320-3005 | PHASE III

Sponsor:
Osmotica Pharmaceutical Corporation

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 30 Years to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
- Signed IRB/IEC informed consent form.,
- Idiopathic Parkinson's disease per the UK Parkinson's Disease Society Brain Bank criteria.
- Male or female 30 to 85 years old.
- Levodopa induced, predictable peak-effect dyskinesia considered problematic and/or disabling.
- Screening serum creatinine level within normal range
- On stable doses of all oral anti-Parkinson's medication, including any levodopa preparation, for 30 days and be willing to remain on the same doses throughout the trial.
- The subject/caregiver must demonstrate the ability to complete an accurate home diary based on training and evaluation during the screening period.

Exclusion Criteria:
-Secondary parkinsonian syndrome, such as vascular, postinflammatory,drug-induced, neoplastic and post-traumatic parkinsonism or any atypical parkinsonian syndrome (e.g., Progressive Supranuclear Palsy, Multi-System Atrophy, etc.);
- Use of amantadine within 14 days before study start, or previously had an adverse event to amantadine
- Currently taking neuroleptics and atypical antipsychotic agents, acetylcholinesterase inhibitors, apomorphine, rimantadine, memantine and dextromethorphan and quinidine if used in combination for treating dyskinesia.
- History of neurosurgical intervention for treating Parkinson's s disease (i.e. pallidotomy or implanted with a deep brain stimulator).
- Any medical condition or past medical history that would increase the risk of exposure to Amantadine HCl Extended Release Tablets or interfere with safety and efficacy evaluations.
- History of cancer within 5 years of screening with following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer.
- History or current diagnosis of schizophrenia or bipolar disorder;
- Inadequately treated Major Depressive Disorder. Subjects on stable doses of selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) are eligible for the study.
- Is at imminent risk of suicide or had a suicide attempt within 6 months of screening
- History or current diagnosis of Impulse Control Disorder
- Calculated plasma creatinine clearance of <60 mL/min at screening
- History of or currently has any of the following clinically significant conditions, cardiovascular, respiratory, renal, hepatic, or gastrointestinal disease
- Any clinically significant vital sign, ECG, or laboratory abnormalities:
- A positive test for HIV antibody or history of HIV; hepatitis B surface antigen unless the positive test followed a recent (<28 days) vaccination for hepatitis B; hepatitis C antibody.
- A positive urine drug test.
- Pregnant or breastfeeding at screening or has a positive pregnancy test
- If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from the screening visit to at least 4 weeks after the completion of study treatment.
- History of alcohol or narcotic substance abuse ≤1 year before screening.
- Has dementia or another psychiatric illness that prevents provision of informed consent.
- Has a known hypersensitivity to the study treatment(s), based on known allergies to drugs of the same class including rimantadine HCl and memantine HCl.
- Has participated in other studies involving investigational drugs or surgeries within the last 30 days or investigational biologics within the last 6 months prior to screening.
- Plans to undergo major elective surgery during the course of the study.
- Received administration of Live Attenuated Influenza Vaccine (LAIV) within 2 weeks.
- Cognitive impairment, as evidenced by a score <26 on the Montreal Cognitive Assessment (MoCA) at the screening visit.

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Contact:
908-522-7991
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Parkinson's Disease
Open to Enrollment

A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias

Amantadine HCl ER has been used for many years as a treatment for Parkinson's disease. It has been reported in the literature to effectively treat the motor complications of levodopa, especially dyskinesia, but it must be given 2 to 4 times a day. The purpose...

Investigator:
Marcie Rabin, MD

of this multi-center, randomized, double-blind, parallel-group, 26 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease. The dose will be given once a day in the morning so that amantadine concentrations are maintained throughout the day for treating the levodopa induced dyskinesia, but will be lower during the night, potentially reducing the negative impact of amantadine on sleep.

OS320-3006 | PHASE III

Sponsor:
Osmotica Pharmaceutical Corporation

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 30 Years to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

- Signed IRB/IEC informed consent form.
- Idiopathic Parkinson's disease per the UK Parkinson's Disease Society Brain Bank criteria.
- Male or female 30 to 85 years old.
- Levodopa induced, predictable peak-effect dyskinesia considered problematic and/or disabling.
- Screening serum creatinine level within normal range
- On stable doses of all oral anti-Parkinson's medication, including any levodopa preparation, for 30 days and be willing to remain on the same doses throughout the trial.
- The subject/caregiver must demonstrate the ability to complete an accurate home diary based on training and evaluation during the screening period.

Exclusion Criteria:
- Secondary parkinsonian syndrome, such as vascular, postinflammatory,drug-induced, neoplastic and post-traumatic parkinsonism or any atypical parkinsonian syndrome (e.g., Progressive Supranuclear Palsy, Multi-System Atrophy, etc.);
- Use of amantadine within 14 days before study start, or previously had an adverse event to amantadine
- Currently taking neuroleptics and atypical antipsychotic agents, acetylcholinesterase inhibitors, apomorphine, rimantadine, memantine and dextromethorphan and quinidine if used in combination for treating dyskinesia.
- History of neurosurgical intervention for treating Parkinson's s disease (i.e. pallidotomy or implanted with a deep brain stimulator)
- Any medical condition or past medical history that would increase the risk of exposure to Amantadine HCl Extended Release Tablets or interfere with safety and efficacy evaluations.
- History of cancer within 5 years of screening with following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer.
- History or current diagnosis of schizophrenia or bipolar disorder;
- Inadequately treated Major Depressive Disorder. Subjects on stable doses of selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) are eligible for the study;
- Is at imminent risk of suicide or had a suicide attempt within 6 months of screening
- History or current diagnosis of Impulse Control Disorder
- Calculated plasma creatinine clearance of <60 mL/min at screening
- History of or currently has any of the following clinically significant conditions, cardiovascular, respiratory, renal, hepatic, or gastrointestinal disease
- Any clinically significant vital sign, ECG, or laboratory abnormalities;
- A positive test for HIV antibody or history of HIV; hepatitis B surface antigen unless the positive test followed a recent (<28 days) vaccination for hepatitis B; hepatitis C antibody;
- A positive urine drug test.
- Pregnant or breastfeeding at screening or has a positive pregnancy test
- If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from the screening visit to at least 4 weeks after the completion of study treatment.
- History of alcohol or narcotic substance abuse ≤1 year before screening.
- Has dementia or another psychiatric illness that prevents provision of informed consent.
- Has a known hypersensitivity to the study treatment(s), based on known allergies to drugs of the same class including rimantadine HCl and memantine HCl.
- Has participated in other studies involving investigational drugs or surgeries within the last 30 days or investigational biologics within the last 6 months prior to screening.
- Plans to undergo major elective surgery during the course of the study.
- Received administration of Live Attenuated Influenza Vaccine (LAIV) within 2 weeks.
- Cognitive impairment, as evidenced by a score <26 on the Montreal Cognitive Assessment (MoCA) at the screening visit.

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Contact:
908-522-7991
research@atlantichealth.org

More info:
ClinicalTrials.gov

More Detail
Parkinson's Disease
Open to Enrollment

A Randomized, Double-blind, Placebo-controlled Trial of Urate-elevating Inosine Treatment to Slow Clinical Decline in Early Parkinson's Disease

A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial to determine whether oral inosine dosed to moderately elevate serum urate (from =5.7 mg/dL to 7.1-8.0 mg/dL) over 2 years slows clinical decline in early PD. Clinical decline will be...

Investigator:
Marcie Rabin, MD

assessed as change in the primary outcome variable of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), a composite scale comprising patient- and clinician-reported outcomes.

SURE-PD3 | PHASE III

Sponsor:
National Institute of Health

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 30 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

INCLUSION CRITERIA:

Study subjects meeting all of the following criteria will be allowed to enroll in the study:
1. Willingness and ability to give written informed consent and to comply with trial procedures.
2. Fulfillment of diagnostic criteria for idiopathic PD with at least two of the cardinal signs of PD (resting tremor, bradykinesia, rigidity) present at 2nd screening and baseline evaluations, as assessed by the Site Investigator.
3. Absence of current or imminent (within 90 days of enrollment) PD disability requiring dopaminergic therapy, as assessed by the Site Investigator.
4. Modified Hoehn and Yahr Scale Stage 1 to 2.5 inclusive.
5. Age 30 or older at the time of PD diagnosis.
6. Diagnosis of PD made within 3 years prior to 1st Screening Visit.
7. Non-fasting serum urate ≤ 5.7 mg/dL at 1st Screening Visit (SC1).
8. If the subject is female, then:
a. Being surgically sterile (hysterectomy or tubal ligation), or
b. Being postmenopausal (last menstruation was two years or more prior to 2nd Screening Visit), or
c. For those of childbearing potential
◾ Using a reliable form of contraception for 60 days or more prior to Baseline Visit and agreeing to continue such use for 30 days post last dose of study drug. Reliable forms of contraception include: abstinence; implanted, injected or oral contraceptives (birth control pills), intrauterine device in place for at least 3 months prior to Baseline Visit, vaginal ring with spermicide, barrier with spermicide such as male or female condom, diaphragm or cervical cap, transdermal patch; male partner with vasectomy.
◾ And having a negative pregnancy test at the 2nd Screening Visit. [Note that a urine pregnancy test will be performed at screening on all women who are not at least two years postmenopausal or surgically sterile.]

EXCLUSION CRITERIA:

Study subjects meeting any of the following criteria during screening evaluations will be excluded from entry into the study:
1. Atypical parkinsonism, including that due to drugs, metabolic disorders, encephalitis, cerebrovascular disease, normal pressure hydrocephalus, or other neurodegenerative disease.
2. Dopamine transporter (DAT) brain scan without evidence of dopamine deficit.
3. History of gout.
4. History of uric acid or urate urolithiasis, or recurrent urolithiasis all of unknown type.
5. A screening test positive for uric acid crystalluria, urine pH ≤ 5.0, or an estimated glomerular filtration rate < 60 ml/min/1.73 m2.
6. History of myocardial infarction or stroke.
7. Symptomatic congestive heart failure with a documented ejection fraction below 45%.
8. History of severe chronic obstructive pulmonary disease.
9. Mini Mental State Exam score < 25; i.e., a score of 0 to 24.
10. Use of any anti-parkinsonian medication (including levodopa, dopamine agonists, amantadine, entacapone and the anticholinergic agents trihexyphenidyl and benztropine) other than monoamine oxidase-B inhibitors within 60 days of Baseline, or in excess of 90 days.
11. Change in the dosage of (or initiation of) a monoamine oxidase-B (MAO-B) inhibitor within 90 days prior to Baseline, i.e., entry on a MAO-B inhibitor requires a stable dosage for the 90 days prior to Baseline.
12. Use of the following within 30 days prior to the Baseline Visit: inosine, allopurinol, febuxostat, probenecid, more than 50 IU of vitamin E daily, or more than 300 mg of vitamin C daily (though a daily standard multivitamin such as Bayer One-A-Day® or Centrum® is permissible), reserpine, methylphenidate, amphetamines, cinnarizine, monoamine oxidase-A inhibitors, tetrabenazine, neuroleptics or other dopamine blocking drugs.
13. Use of the following within 90 days prior to the DAT neuroimaging screening evaluation: modafinil, armodafinil, metoclopramide, alpha-methyldopa, methylphenidate, reserpine, or amphetamine derivative.
14. Unstable dosing of a thiazide -- such as hydrochlorothiazide (e.g., Esidrex), chlorothiazide (e.g., Diuril), chlorthalidone (e.g., Hygroton), indapamide (e.g., Lozol), metolazone (e.g., Zaroxolyn), which are permissible as long as the subject is on a stable dose from 1 week prior to the 1st Screening Visit through the Baseline Visit.
15. Known unstable medical or psychiatric condition that may compromise participation in the study. (Note that difficulty swallowing large capsules might preclude participation due to the size of the study drug capsules.)
16. Clinically serious abnormality in the screening visit laboratory studies or ECG, as determined by the Site Investigator.
17. Participation in another investigational treatment study within 30 days prior to the Baseline Visit.
18. Known hypersensitivity or intolerability to inosine.
19. Known hypersensitivity to DaTscan (either the active substance of ioflupane I-123 or to any of the excipients).

Contact:
908-598-7991
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Parkinson's Disease
Open to Enrollment

SYN120 a Dual 5-HT6/5-HT2A Antagonist Proof of Concept Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)

The purpose of this study placebo-controlled, randomized, double-blind study is to assess the safety and efficacy of SYN120 in patients with Parkinson's disease dementia (PDD) already treated with a stable dose of a cholinesterase inhibitor.

Investigator:
Marcie Rabin, MD
SYNAPSE | PHASE II

Sponsor:
Biotie Therapies, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 50 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Parkinson's Disease Dementia
• Patient has a routine caregiver
• Taking a stable cholinesterase inhibitor.
• Patient has a Montreal Cognitive Assessment (MoCA) 10-23 inclusive

Exclusion Criteria:
• History of any significant neurologic or psychiatric disease other than PD
• Any other condition or clinically significant abnormal findings that would make the patient unsuitable for the study
• Unpredictable motor fluctuations that would interfere with administering assessments

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Contact:
908-598-7991
research@atlantichealth.org

More info:
ClinicalTrials.gov

More Detail
Parkinson's Disease
Open to Enrollment

Yoga and Parkinson’s Disease: A Pilot Study

This research study aims to evaluate the impact that a yoga program may have on patients with Parkinson’s disease (PD). Eligible participants will be randomly assigned to one of two groups. One group will participate in a one-hour yoga class, twice per week,...

Investigator:
Marcie Rabin, MD

for 16 weeks. The other (control) group will receive their usual medical care for PD but will not participate in any yoga program. Twice the number of participants will be assigned to the yoga group than to the control group.

Yoga

Sponsor:

Inclusion & Exclusion Criteria:
INCLUSION CRITERIA
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
1. Male or female 40 years of age or older.
2. Clinical diagnosis of idiopathic Parkinson’s Disease and still independently ambulatory.
3. Subjects willing to sign the informed consent document indicating that they understand the purpose and procedures for the study and are willing to participate in the study.

EXCLUSION CRITERIA
Subjects meeting any of the listed criteria cannot participate in the study:
1. Currently practicing yoga.
2. Cognitive or motor impairment which would interfere with the subject’s ability to appropriately take part in the yoga activities.

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Contact:
908-522-5901
research@atlantichealth.org

More info:
ClinicalTrials.gov