Actively Recruiting
SAD Study in Patients With Parkinson's Disease and Motor Fluctuations
Led by Serina Therapeutics · Updated on 2026-04-21
40
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, placebo-controlled, single ascending dose (SAD) study of SER-252 in participants with Parkinson's Disease (PD) and motor fluctuations.
CONDITIONS
Official Title
SAD Study in Patients With Parkinson's Disease and Motor Fluctuations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male participants 40 to 80 years of age at screening
- Diagnosis of idiopathic Parkinson's disease consistent with UK Brain Bank and MDS Research Criteria
- Stable anti-Parkinsonian medication regimen for at least 4 weeks prior to screening
- Routine early-morning OFF state confirmed by investigator interview
- Total daily OFF time of at least 2 hours during waking day
- Hoehn and Yahr scale 3 or less in ON state during screening
- Levodopa taken at least 4 times daily (immediate or extended release) or 3 times daily (Rytary or Crexont)
- Ability to attend clinic for scheduled assessments
- Montreal Cognitive Assessment score of 24 or higher
- Women of child-bearing potential must use reliable contraception and have negative pregnancy tests
- Male participants with partners of childbearing potential must use condoms and ensure partner uses contraception
- Willing and able to comply with all study activities and safety follow-up
- Provide written informed consent
- Approval by central Enrollment Authorization Committee
You will not qualify if you...
- Diagnosis of secondary or atypical parkinsonism
- Prior continuous levodopa therapy or dopaminergic stimulation procedures, or plans for such during study
- History of diphasic, OFF state, myoclonic, or dystonic dyskinesias without peak-dose choreiform dyskinesia
- Severe, disabling dyskinesias or severe OFF motor complications
- Inability to differentiate motor states after training
- Clinically significant symptomatic orthostatic hypotension or requiring medication
- Hallucinations requiring antipsychotic use
- Significant medical, surgical, psychiatric, or laboratory abnormalities precluding study participation
- Clinically significant ECG abnormalities or prolonged QTcF interval (>450 ms males, >470 ms females)
- Significant heart disease within 2 years prior to screening including recent cardiac events, complex arrhythmias, symptomatic bradycardia, unexplained syncope, Brugada syndrome, or hypertrophic cardiomyopathy
- Active major depressive disorder or significant impulse control disorder
- Active suicidal ideation within 1 year or suicide attempt within 5 years
- Substance-related disorder within 12 months prior to screening (excluding nicotine and caffeine)
- Positive screening for drugs of abuse (except prescribed medications)
- Elevated liver enzymes (ALT or AST >2.5x ULN) or bilirubin >2.0 mg/dL
- Significant renal impairment (eGFR ≤55 ml/min or serum creatinine >2.0 mg/dL)
- Positive test for hepatitis B, hepatitis C, or HIV
- Currently pregnant, lactating, or planning pregnancy during study
- Previous intolerance to apomorphine
- Participation in another investigational study within 30 days or 5 half-lives, or 90 days for biologics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Rocky Mountain Clinical Research
Englewood, Colorado, United States, 80113
Not Yet Recruiting
2
Velocity Clinical Research
Hallandale, Florida, United States, 33009
Not Yet Recruiting
3
K2 Medical Research LLC
Maitland, Florida, United States, 32751
Actively Recruiting
4
Quest Research Institute
Farmington Hills, Michigan, United States, 28555
Actively Recruiting
5
CMAX
Adelaide, South Australia, Australia, 5000
Actively Recruiting
6
Monash
Melbourne, Victoria, Australia, 3170
Actively Recruiting
Research Team
R
Randall Moreadith, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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