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New treatment option for PARKINSON DISEASE (Disorder)
Official title SAD Study in Patients With Parkinson's Disease and Motor Fluctuations
ClinicalTrials.gov ID: NCT07422675
What this study is testing
What is SER-252 (PEOZ-apomorphine)?
SER-252 (PEOZ-apomorphine) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for parkinson disease (disorder).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized, placebo-controlled, single ascending dose (SAD) study of SER-252 in participants with Parkinson's Disease (PD) and motor fluctuations.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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...
- 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...
- 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
You likely can't join if
- 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...
- 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)
See the full eligibility 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...
- 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...
- 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)
- 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...
- 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...
- 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)...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Englewood, Colorado, United States
- Hallandale, Florida, United States
- Maitland, Florida, United States
- Farmington Hills, Michigan, United States
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Englewood, Colorado, United States; Hallandale, Florida, United States; Maitland, Florida, United States; Farmington Hills, Michigan, United States; Adelaide, South Australia, Australia; Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.