Is NCT07005180 recruiting in East Lansing, MI?

Yes, NCT07005180 is currently recruiting participants at its East Lansing, MI location. This parkinson disease clinical trial is actively enrolling qualified participants.

How do I join the parkinson disease clinical trial in East Lansing?

To join this clinical trial in East Lansing, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this East Lansing clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Parkinson Disease Clinical Trial in East Lansing, MI

About This Parkinson Disease Study in East Lansing

A phase 2a multicenter, randomized, double-blind, placebo-controlled multiple dose study to evaluate the safety, tolerability, pharmacokinetics, of HBI-002, an oral low-dose carbon monoxide (CO) liquid drug product, administered daily over 14 days in subjects with Parkinson's disease (PD).

Sponsor: Hillhurst Biopharmaceuticals, Inc.

Who Can Participate

Inclusion Criteria

Subjects must meet the following criteria before being enrolled into the study:

Signed informed consent.

Male or female 40-80 years of age

Non-smoker for at least 5 years with smoking defined as the use of smoked products (e.g. tobacco, marijuana, vaping or other)

No smoking in the home (i.e. not living with a smoker)

Body weight between 60 kg and 110 kg (inclusive) and with BMI less than 30 kg/m2 at screening and baseline

Diagnosis of PD according to the Movement Disorder Society within 60 months of screening

Hoehn and Yahr stage ≤ 3

PD therapy: use of ≥100 mg TID levodopa or equivalent dose with additional carbidopa/levodopa or other antiparkinsonian medication (e.g. dopamine agonists \[e.g., pramipexole, ropinirole, rotigotine\] and monoamine oxidase inhibitors \[e.g., selegiline or rasagiline\]) for ≥30 days of stable dosing

Good clinical response to levodopa therapy in the Site Investigator's opinion

Negative pregnancy test for females of childbearing potential

Where appropriate, subjects must be willing to use a highly effective method of contraception for the duration of the study and for 45 days thereafter

Male subjects, without a vasectomy, whose partner is of childbearing potential, must use a condom and be instructed that their female partner should use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant or a tubal ligation. Male subjects are prohibited from donating sperm for the duration of the study and 60 days following the end of study visit.

Female subjects of childbearing potential (not surgically sterilized and less than one year post-menopausal) should use a medically accepted form of contraception such as an IUD, diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant or a tubal ligation, and be instructed that their male partners should use a condom, if not vasectomized.

Subjects must be healthy as defined by the following.

liver function: alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2X ULN

total bilirubin ≤ 1.5X ULN

renal function: creatinine clearance within normal range as assessed by Cockcroft and Gault calculation

carboxyhemoglobin level by venous blood gas ≤ 3.5%

the absence of current clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure, pulse rate, and respiratory rate measurement, 12-lead ECG, and clinical laboratory tests (hematology and clinical chemistries), as determined by the Site Investigator.

HbA1c \< 6.5%

Subjects must have a study partner who can observe the subject for at least 4 hours after dosing at home (non-clinic days) in order to monitor for indications of CO toxicity.

Subjects should live within 100 miles driving distance (door to door) of the site/clinic due to the need to carry study drug and ship study drug between the site/clinic and subject's home. Exceptions to this may be considered with Sponsor approval if it can be assured that the subject can transport study drug from clinic to home within two hours.

Exclusion Criteria

Subjects who meet any of the following criteria will be ineligible for participation in the study:

Clinical signs indicating a parkinsonian syndrome other than idiopathic PD, specifically:

Atypical parkinsonism, including parkinsonism due to drugs, metabolic disorders, encephalitis, cerebrovascular disease, normal pressure hydrocephalus, or other neurodegenerative disease.

Supranuclear gaze palsy

Signs of dementia (MoCA \< 22)

History of repeated strokes with stepwise progression of parkinsonian features

History of repeated head injury

History of definite encephalitis

Cerebellar signs

Early severe autonomic involvement

Babinski sign present

Dysphagia with liquids

History of exposure to or current treatment with neuroleptic drugs.

History of dementia

Oxygen saturation by transcutaneous measurement ≤ 95% confirmed on repeat assessment (any time prior to the first dose)

Clinically significant ECG abnormalities (prolonged QTc greater than normal range, arrhythmia detected, bradycardia \<45 bpm, tachycardia \>120 bpm, AV block \[second or greater degree\], bundle branch block) or vital sign abnormalities (systolic blood pressure lower than 90 or above 140 mm Hg, diastolic blood pressure lower than 50 or above 90 mm Hg, or heart rate less than 45 or above 100 bpm or arrhythmia), as determined by the Site Investigator.

Renal failure requiring renal replacement therapy

History of:

Serious cardiovascular diseases

History of angina pectoris

History of myocardial infarction or cardiac failure (NYHA from II to IV), myocardial insufficiency, symptomatic congestive heart failure with a documented ejection fraction below 45%

History of serious cardiac arrhythmia other than stable atrial fibrillation

History of stroke or occlusive peripheral vascular disease, brain vasospasm

Structural brain disease or cerebrovascular disease with clinical significance, including intracranial space-occupying lesion

Severe uncontrolled arterial hypertension

Severe pulmonary disease (asthma, COPD, other)

Specific psychiatric disorders, including hallucinations, delusions, pathologic gambling, alcohol or substance abuse or dependence

Type 1 or type 2 diabetes mellitus, impaired glucose tolerance, metabolic syndrome, maturity onset diabetes of the young, and gestational diabetes.

Pulmonary infiltrate or pneumonia within 6 months before screening or acute infection within 14 days of screening

Seizures / epilepsy

Autoimmune disease requiring prescribed immunomodulatory therapy

Alcohol abuse or dependence within one year prior to screening or regular use of alcohol within six months prior to the screening visit (defined as more than 14 units of alcohol per week; 1 Unit = 150 mL wine, 360 mL beer or 45 mL of 40% alcohol)

History of drug abuse or dependence

Positive result on drug screen for THC, cocaine, opiates/opioids, and methamphetamine

History of cancer, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin more than 3 months prior

Subject on domiciliary oxygen

Positive HBsAg, aHCV, or aHIV

Positive SARS-CoV-2 test within 10 days prior to study drug treatment

Weight loss or gain of more than 5 kg within 3 months of screening

Febrile or infective illness within 10 days prior to study drug treatment

Moderate or more severe depression (Geriatric Depression Scale (GDS) ≥9)

Suicide attempt or suicidal ideation within five years (Columbia-Suicide Severity Rating Scale (C-SSRS) defined as answering yes to items 4 or 5 on the C-SSRS, or history of suicide attempt in previous 5 years, or, in the Investigator's opinion, at serious risk of suicide.

Positive pregnancy test or breast feeding for females

Treatment with an investigational drug or medical device within the longer of 60 days or ten half-lives of the investigational agent

Simultaneous participation or previous participation within 60 days before screening in another clinical drug or medical device study

Persisting anemia with hemoglobin \<9 g/dL

Blood transfusion within 42 days prior to the first administration of study drug

Exposure to any live vaccine within 28 days prior to study drug administration

Syncope or other cause of loss of consciousness within the last 2 years

Unwilling or unable to respond to follow-up phone calls

Unwilling or unable to communicate with study site staff by telephone

Unwilling or unable to comply with the requirements of the protocol

Any coincident disease or condition that in the opinion of the Site Investigator will confound the assessment of HBI-002 safety or efficacy

Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Site Investigator, would make the subject inappropriate for entry into the study

History of allergic reactions to any of the drug product excipients

Contraindications to a routine lumbar puncture

History of thrombocytopenia (platelet count \<100,000)

History of coagulopathy (INR \>1.3, PTT \>ULN)

Current use of warfarin or other anticoagulants, or clopidogrel (Plavix)

History of lumbar surgery or severe spinal arthritis

Infection at LP site (may be included once resolved)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in East Lansing?

Yes, this clinical trial (NCT07005180) has an active research site in East Lansing, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Parkinson Disease Treatment Options in East Lansing, MI

If you're searching for parkinson disease treatment options in East Lansing, MI, this clinical trial (NCT07005180) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our East Lansing research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced parkinson disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all parkinson disease clinical trials near you to find additional studies recruiting in your area.

Parkinson Disease Clinical Trial in East Lansing, MI

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