Parkinson’s Disease
Conditions
Brief summary
Change from Baseline to Month 18 in normalized Good ON time measured with PD Motor Diary
Detailed description
Change from Baseline to Month 18 in the following measures: -MDS-UPDRS part III score in the practically defined OFF state -FDOPA uptake in the putamen as assessed by PET -Normalized OFF time measured with PD Motor Diary -MDS-UPDRS part III score in the ON state -MDS-UPDRS part II score in the OFF state -UDysRS total score -PDQ-39 summary index -NMSS total score, Incidence and severity of AEs, TEAEs, and SAEs, Vital signs, Safety laboratory assessments, Neurological and physical examinations, Antibody responses to AAV2 and/or GDNF, T-cell responses against AAV2 and/or GDNF, C-SSRS, Shedding of AAV2-GDNF
Interventions
DRUGProHance
DRUG279
DRUG3 mg/ml (0
DRUG5 mmol/ml)
DRUGFluorodopa (18F)
DRUGAAV2-GDNF
DRUG0
DRUG5 M
DRUGInjektionslösung
DRUGCarbidopa
DRUGDOPAVIEW® 222 MBq/ml Injektionslösung
Sponsors
Askbio Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to Month 18 in normalized Good ON time measured with PD Motor Diary | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline to Month 18 in the following measures: -MDS-UPDRS part III score in the practically defined OFF state -FDOPA uptake in the putamen as assessed by PET -Normalized OFF time measured with PD Motor Diary -MDS-UPDRS part III score in the ON state -MDS-UPDRS part II score in the OFF state -UDysRS total score -PDQ-39 summary index -NMSS total score, Incidence and severity of AEs, TEAEs, and SAEs, Vital signs, Safety laboratory assessments, Neurological and physical examinations, Antibody responses to AAV2 and/or GDNF, T-cell responses against AAV2 and/or GDNF, C-SSRS, Shedding of AAV2-GDNF | — |
Countries
Germany, Poland
Outcome results
None listed