SAD Study in Patients With Parkinson's Disease and Motor Fluctuations
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-80
SponsorSerina Therapeutics
About this trial
This is a randomized, placebo-controlled, single ascending dose (SAD) study of SER-252 in participants with Parkinson's Disease (PD) and motor fluctuations.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- SER-252 (PEOZ-apomorphine)
- enFuse
Treatment groups
40 Participants
are divided into 2 treatment groupsLocations
6Australia
CMAX5000, AdelaideSouth Australia, Australia
Monash3170, MelbourneVictoria, Australia
United States
Rocky Mountain Clinical Research80113, EnglewoodColorado, United States
Velocity Clinical Research33009, HallandaleFlorida, United States
Sponsors and collaborators
Serina Therapeutics
Lead sponsor
Source ClinicalTrials.gov