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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 tourette

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Tourette
Open to Enrollment

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of NBI-98854 in Adult Subjects With Tourette Syndrome

Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of NBI-98854 administered once daily (qd) for a total of 8 weeks of treatment. This study will enroll approximately 90 male and female subjects clinically diagnosed with Tourette...

Investigator:
Roger Kurlan, MD

Syndrome.

NBI-98854-1505 | PHASE II

Sponsor:
Neurocrine Biosciences, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 64 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Have a clinical diagnosis of Tourette Syndrome (TS)
2. Have at least moderate tic severity
3. Have TS symptoms that impair school, occupational, and/or social function
4. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]), be on stable doses
5. Be in good general health
6. Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, or opiates, and a negative alcohol screen
7. Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study

Exclusion Criteria:
1. Have an active, clinically significant unstable medical condition within 1 month prior to screening
2. Have a known history of long QT syndrome or cardiac tachy-arrhythmia
3. Have a known history of neuroleptic malignant syndrome
4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors.
6. Are currently pregnant or breastfeeding
7. Have a known history of substance dependence, substance (drug) or alcohol abuse
8. Have a significant risk of suicidal or violent behavior
9. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study
10. Have a blood loss ≥550 mL or donated blood within 30 days prior to screening

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

More info:
ClinicalTrials.gov

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Tourette
Open to Enrollment

An Open-Label, Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects with Tourette Syndrome

Phase 2, open-label, fixed-dose titration study to evaluate the safety and tolerability of NBI-98854 administered once daily for a total of 24 weeks in children, adolescents, and adults with Tourette Syndrome (TS).

Investigator:
Marcie Rabin, MD
NBI-98854-1601 | PHASE II

Sponsor:
Neurocrine Biosciences, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 6 Years to 64 Years (Child, Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Have participated in and completed the NBI-98854-1501 (T-Force Green) or NBI-98854-1505 (T-Forward) Phase 2 study
• Have a clinical diagnosis of Tourette Syndrome (TS)
• If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]), be on stable doses
• Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study
• Adolescent and adult subjects (12 to 64 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen. Subjects who are on stable doses of prescribed and supervised (not as needed) benzodiazepines, opiates, or psychostimulants (for subjects with comorbid ADHD) are allowed to participate in the study
• Be in good general health

Exclusion Criteria:
• Have an active, clinically significant unstable medical condition within 1 month prior to screening
• Have a known history of long QT syndrome or cardiac arrhythmia
• Have a known history of neuroleptic malignant syndrome
• Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
• Have a blood loss ≥250 mL or donated blood within 56 days prior to screening (subjects 6 to 17 years of age); have a blood loss ≥550 mL or donated blood within 30 days prior to screening (subjects 18 to 64 years of age)
• Have a known history of substance dependence, substance (drug) or alcohol abuse
• Have a significant risk of suicidal or violent behavior
• Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
• Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study

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

More info:
ClinicalTrials.gov

More Detail
Tourette
Open to Enrollment

Ecopipam Treatment of Tourette’s Syndrome in Subjects 7-17 Years/PSY302

Tourette's Syndrome is a neurological disease characterized by motor and vocal tics. It has been hypothesized that abnormal interactions of dopamine with its receptors may cause the tics. The purpose of this study is to test the hypothesis that a drug (ecopipam)...

Investigator:
Roger Kurlan, MD

that selectively blocks dopamine D1/D5 receptors can reduce the frequency and severity of the tics.

PSY302 | PHASE II

Sponsor:
Psyadon Pharmaceuticals, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 7 Years to 17 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria: Subjects must have Tourette's Syndrome (TS) based on the clinician-administered Diagnostic Confidence Index (DCI) for TS.

• Subjects must exhibit both motor and vocal tics.
• Subjects must have a minimum score of 20 at both Screening and Baseline (just prior to the first treatment) on the Yale Global Tic Severity Scale.
• Subjects must be age (≥ 7 to < 18 years of age)
• Subjects must weigh ≥ 20 kg (45 lbs)
• Adolescent females of childbearing potential who are sexually active must be using effective contraception (i.e., oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for the duration of their participation in the study. They must also agree to use contraception for 30 days after their last dose of study drug.
• Sexually active male subjects must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.
• Subject's parent or legal guardian must execute a written informed consent.
• Subject must execute a written informed assent.

Exclusion Criteria:
• Subjects who have unstable medical illness or clinically significant abnormalities on laboratory tests, or ECG at Screening.
• Subjects with a major depressive episode in the past 2 years
• Subjects with a history of attempted suicide
• Subjects with clinically significant suicidality (based on the Columbia Suicide Rating Scale (C-SSRS)
• Subjects with a first-degree relative with a major depressive episode that resulted in any psychiatric hospitalization, or attempted/ completed suicide with the exception of a hospitalization for post-partum depression.
• Subjects with a history of seizures (excluding febrile seizures that occurred >2 years in the past)
• Subjects with a myocardial infarction within 6 months.
• Girls who are currently pregnant or lactating.
• Subjects who have a need for medication (other than ecopipam) with possible effects on TS symptoms (i.e., lithium, psychostimulants)
• Subjects who have a need for medications which would have unfavorable interactions with ecopipam, e.g., dopamine antagonists or agonists [including bupropion], tetrabenazine, or monoamine oxidase inhibitors.
• Subjects with a lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any psychotic disorder determined by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) Axis-I Disorders (SCID).
• Subjects with current or recent (past 3 months) DSM-IV substance abuse or dependence (with the exception of nicotine).
• Subjects with positive urine drug screen (cocaine, amphetamine, methamphetamine, tetrahydrocannabinol (THC), benzodiazepines, barbiturates, phencyclidine (PCP), opiates) at Screening. Subjects with urine positive only for benzodiazepines and/or marijuana (i.e., a user but not an abuser as based on DSM-IV criteria) may be eligible.
• Subjects who have had previous treatment with ecopipam.
• Subjects who have had treatment with:
o investigational medication within 3 months of starting study
o depot neuroleptics within 3 months of starting study
o other psychotropics with possible effects on TS symptoms (i.e., lithium, tetrabenazine) within 2 weeks prior to Screening.
o oral neuroleptics within 4 weeks
o selective serotonin reuptake inhibitors unless the dosage has been stable for a minimum of 4 weeks prior to study start and not prescribed to relieve the neurological signs of TS

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

More info:
ClinicalTrials.gov

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Tourette
Open to Enrollment

Multimodal Dietary Treatment in Tourette’s Syndrome

This study involves patients with TS ages 12-17 . We are testing a group of dietary supplements that act to increase inhibitory chemical signals in the brain, detoxify environmental toxins, strengthen the body’s metabolism, and support brain nerve cell membranes....

Investigator:
Roger Kurlan, MD

Subjects will also follow a Whole Food diet. This study lasts for 8 weeks and involves 3 visits to our office.

Dietary Tourette

Sponsor:

Inclusion & Exclusion Criteria:
Enrollment Criteria:
Male or Female of any race/ethnicity, age 12-17 years, meets DSM-5 criteria for TS, Yale Global Tic Severity Scale (YGTSS) Total Tic Score > 22, tics cause problems in daily living and justify the need for treatment, able to swallow study supplements and willing to follow the recommended diet. Subjects will be allowed to take medications for TS, but the tics must still cause problems in daily living and the severity must be rated > 22 on the YGTSS Total Tic Score. Subjects will be allowed to take medications for associated problems such as OCD or ADHD, but they should remain unchanged during the trial. Behavioral and cognitive behavioral treatments for tics, ADHD or OCD are allowed if they have been initiated at least 8 weeks prior to baseline and will not increase during the study. Subjects with a secondary tic disorder (e.g., due to medications or other neurological disorder such as autism spectrum disorder, mental retardation, head trauma, encephalitis, Huntington’s disease) will be excluded. Subjects already diagnosed with a food allergy or insensitivity (e.g., to gluten, food dyes or flavoring agents) will be allowed to participate and will continue any elimination diets being followed. Individuals taking a medication with a known potentially adverse drug interaction with one of our supplements will be excluded. These include barbiturates and benzodiazepines (valerian), oral hypoglycemic drugs and warfarin (niacin), proton pump inhibitors (vitamin B12), theophylline (vitamin B6, alpha-lipoic acid), and tetracycline (magnesium).

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

More info:
ClinicalTrials.gov

More Detail
Tourette
Open to Enrollment

Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome

Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of NBI-98854 administered once daily (qd) for a total of 6 weeks of treatment. This study will enroll approximately 90 male and female pediatric subjects clinically diagnosed...

Investigator:
Roger Kurlan, MD

with Tourette Syndrome.

NBI-98854-1501 | PHASE II

Sponsor:
Neurocrine Biosciences, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 6 Years to 17 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Have a clinical diagnosis of Tourette Syndrome (TS)
2. Have at least moderate tic severity
3. Have TS symptoms that impair school, occupational, and/or social function
4. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]), be on stable doses
5. Be in good general health
6. Adolescent subjects (12 to 17 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen
7. Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study

Exclusion Criteria:
1. Have an active, clinically significant unstable medical condition within 1 month prior to screening
2. Have a known history of long QT syndrome or cardiac arrhythmia
3. Have a known history of neuroleptic malignant syndrome
4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors
6. Have a blood loss ≥250 mL or donated blood within 30 days prior to screening
7. Have a known history of substance dependence, substance (drug) or alcohol abuse
8. Have a significant risk of suicidal or violent behavior
9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
10. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study

Share

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

More info:
ClinicalTrials.gov