EARLY IDIOPATHIC PARKINSONS DISEASE Parkinson's disease
Conditions
Interventions
A minimum of 48 eligible participants will be randomized to either receive
selnoflast 200 mg BID or placebo in a double-blind manner in a ratio
active/placebo of 2:1.
Treatment duration will be app
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: *Age 40-85 years *Diagnosis of clinically probable idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) *A time from diagnosis of PD of at least 3 to maximum 60 months at screening Other inclusion criteria can be found in protocol section 5.1
Exclusion criteria
Exclusion criteria: *Medical history indicating a Parkinsonian syndrome other than idiopathic PD *History of brain surgery for PD. *Known carriers for mutations in the following genes: alpha-synuclein, LRRK2, GBA, PRKN, PINK1, or DJ1. *Diagnosis of dementia or another significant central nervous system (CNS) disease other than PD; history of repeated clinically significant head injury as judged by the Investigator; history of epilepsy or seizure disorder other than febrile seizures as a child. Other inclusion criteria can be found in protocol section 5.2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of selnoflast compared to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the pharmacokinetics of selnoflast (and metabolites, as appropriate) in plasma. To evaluate the effect of selnoflast on neuroinflammation in brain areas as measured by TSPO-PET [18F]-DPA-714 imaging binding. | — |
Countries
Netherlands
Outcome results
None listed