Is NCT07422675 recruiting in Hallandale, FL?

Yes, NCT07422675 is currently recruiting participants at its Hallandale, FL location. This parkinson disease (disorder) clinical trial is actively enrolling qualified participants.

How do I join the parkinson disease (disorder) clinical trial in Hallandale?

To join this clinical trial in Hallandale, 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 Hallandale 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 (Disorder) Clinical Trial in Hallandale, FL

Who Can Participate

Inclusion Criteria

Female or male participants 40-80 years of age, inclusive, at the time of screening

Diagnosis of idiopathic Parkinson's disease consistent with UK Brain Bank and MDS Research Criteria; must include bradykinesia with sequence effect, motor asymmetry if no rest tremor, and a reliable, visible response to levodopa

On a stable regimen of anti-Parkinsonian medication for at least 4 weeks prior to Screening; MAOBIs must be stable for at least 12 weeks prior to Screening

Routine early-morning OFF, corroborated by investigator interview at Screening

Presence of a total daily OFF time duration of ≥2 hours during the waking day based on participant self-assessment and Investigator's judgment

\*Hoehn and Yahr scale ≤ 3 in the ON state during screening (\*part of the MDS- UPDRS Part III assessment)

Levodopa administration at least 4 times daily (immediate or extended release) or three times daily (Rytary or Crexont)

Ability to return to the clinic for blood sampling, clinical and laboratory assessment on scheduled days, based upon cohort

Montreal Cognitive Assessment ≥ 24

Women of child-bearing potential (WOCBP) who are sexually active with a male partner must use a reliable method of contraception from the time of consent through at least 3 months after the last dose of study medication. Reliable methods of contraception include oral contraceptive or long-term injectable or implantable hormonal contraceptive, or intra-uterine devices when used in combination with male condoms, and must have a negative serum pregnancy test at Screening and negative urine pregnancy test at baseline. Males who are sexually active and whose partners are females of childbearing potential must agree to use male condoms from the time of consent through 3 months after administration of the last dose of study drug, and their partners must be willing to use a highly effective method of contraception from screening through 3 months after administration of the last dose of study drug.

Willing and able to comply with all study activities and requirements, including safety follow-up

Provide written informed consent

Approved by a central Enrollment Authorization Committee (EAC)

Exclusion Criteria

Diagnosis of secondary or atypical parkinsonism

Any previous procedure or therapy designed to provide continuous levodopa or stimulation of dopaminergic tone (i.e., Duopa, apomorphine), surgery for PD (i.e., DBS), or anticipation of these during the study

History of exclusively diphasic, OFF state, myoclonic or dystonic dyskinesias without peak-dose choreiform dyskinesia

Clinically debilitating motor complications as determined by the principal investigator or delegate (severe, disabling dyskinesias or severe OFF)

Participant inability to differentiate motor states (OFF/ON/ON with mild/moderate/severe dyskinesias) after training

Clinically significant orthostatic hypotension (consistently symptomatic or requires medication)

Clinically significant hallucinations requiring antipsychotic use

Clinically significant medical, surgical, psychiatric, or laboratory abnormalities that in the judgment of the principal investigator or delegate would preclude adequate participation or completion of the study

Clinically significant ECG abnormalities at Screening

Prolonged Fridericia-corrected QT (QTcF) interval on ECG at Screening (defined as a QTcF interval of \>450 msec for males and 470 for females)

Clinically significant heart disease within 2 years of Screening, defined as follows: A. Significant cardiac event within 12 weeks prior to Screening (e.g., admission for myocardial infarction, unstable angina, or decompensated heart failure), angina pectoris or episode of congestive heart failure with symptoms \> grade 2 New York Heart Association classification, or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia B. History of complex arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia) that was symptomatic or required treatment (Common Terminology Criteria for Adverse Events grade 3) C. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia D. Symptomatic bradycardia, sick sinus syndrome or atrioventricular block greater than first degree in the absence of a pacemaker E. Unexplained syncope F. Brugada syndrome G. Hypertrophic cardiomyopathy

Active major depressive disorder or history of clinically significant impulse control disorder, in the opinion of the Principal Investigator or delegate, or EAC. Note: Participants receiving treatment for depression with antidepressants may be enrolled if they have been on a stable daily dose of the antidepressant for at least 8 weeks prior to Screening.

Has active suicidal ideation within one year prior to Screening as determined by the C-SSRS (answer of "yes" on questions 4 or 5) or attempted suicide within the last 5 years

Has been diagnosed with or history of a substance-related disorder (excluding nicotine and caffeine), including alcohol-related disorder by DSM-V criteria, during the 12 months prior to Screening

Tests positive at Screening for drugs of abuse (amphetamines (AMP), barbiturates (BAR), benzodiazepines (BZO), cocaine (COC), opiates (OPI), methamphetamines (MET), methadone (MTD), Phencyclidine (PCP), tetrahydrocannabinol (THC), tricyclic antidepressants (TCA)) Note: does not exclude patients on physician-prescribed medications.

Has ALT or AST levels greater than 2.5 times the ULN or bilirubin \> 2.0 mg/dL, or \> 34.2 µmol/L

Significant renal impairment as determined by eGFR, using Cockcroft-Gault method, less than or equal to 55 ml/min or serum creatinine \>2.0 mg/dL or \>177 µmol/L

Has a positive test result for HBsAg, HCV antibody, or HIV infection at Screening

Currently lactating or pregnant or planning to become pregnant during the study.

Previous intolerance of apomorphine

Currently participating in or has participated in another investigational study within the last 30 days or 5 half-lives, or 90 days for biologics

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 Hallandale?

Yes, this clinical trial (NCT07422675) has an active research site in Hallandale, FL 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 (Disorder) Treatment Options in Hallandale, FL

If you're searching for parkinson disease (disorder) treatment options in Hallandale, FL, this clinical trial (NCT07422675) 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 Hallandale research site is actively enrolling participants for this clinical trial. You'll receive care from experienced parkinson disease (disorder) 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 (disorder) clinical trials near you to find additional studies recruiting in your area.

PARKINSON DISEASE (Disorder) Clinical Trial in Hallandale, FL

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