Open-Label, Multi Stage Study to Optimize the Intraputaminal Administration of AB-1005 Using a Prescriptive Infusion Algorithm (PIA)

Conditions

Parkinson's Disease

Brief summary

End-of-infusion volumetric putaminal coverage as assessed by MRI (Stage 1 and 2)

Detailed description

Duration of surgical procedure (Stage 1 and 2), Change in total volumetric putaminal coverage within approximately 60-120 min from end of infusion (Stage 1), Accuracy of cannula tip placement at targeted first and last infusion stops in putamen (Stage 1 and 2), Incidence and severity of AEs including: SAES, TEAEs, TEAEs related to device and/or surgical procedure, TEAEs related to study drug (Stage 1 and 2), MoCA score (Stage 1 and 2), BDI-II score (Stage 1 and 2), C-SSRS (Stage 1 and 2), Vital sign parameters (Stage 1 and 2), Neurological and physical examinations (Stage 1 and 2), Clinical laboratory measures (Stage 1 and 2), Neuroimaging findings (Stage 1 and 2), Immunological responses to AAV2 and/or GDNF (Stage 1 and 2)

Related papers

No related papers found yet.

Interventions

DRUGAAV2-GDNF

DRUGProHance

DRUG279

DRUG3 mg/ml (0

DRUG5 mmol/ml)

DRUGroztwór do wstrzykiwan

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
End-of-infusion volumetric putaminal coverage as assessed by MRI (Stage 1 and 2)	—

Secondary

Measure	Time frame
Duration of surgical procedure (Stage 1 and 2), Change in total volumetric putaminal coverage within approximately 60-120 min from end of infusion (Stage 1), Accuracy of cannula tip placement at targeted first and last infusion stops in putamen (Stage 1 and 2), Incidence and severity of AEs including: SAES, TEAEs, TEAEs related to device and/or surgical procedure, TEAEs related to study drug (Stage 1 and 2), MoCA score (Stage 1 and 2), BDI-II score (Stage 1 and 2), C-SSRS (Stage 1 and 2), Vital sign parameters (Stage 1 and 2), Neurological and physical examinations (Stage 1 and 2), Clinical laboratory measures (Stage 1 and 2), Neuroimaging findings (Stage 1 and 2), Immunological responses to AAV2 and/or GDNF (Stage 1 and 2)	—

Measure

Time frame

Duration of surgical procedure (Stage 1 and 2), Change in total volumetric putaminal coverage within approximately 60-120 min from end of infusion (Stage 1), Accuracy of cannula tip placement at targeted first and last infusion stops in putamen (Stage 1 and 2), Incidence and severity of AEs including: SAES, TEAEs, TEAEs related to device and/or surgical procedure, TEAEs related to study drug (Stage 1 and 2), MoCA score (Stage 1 and 2), BDI-II score (Stage 1 and 2), C-SSRS (Stage 1 and 2), Vital sign parameters (Stage 1 and 2), Neurological and physical examinations (Stage 1 and 2), Clinical laboratory measures (Stage 1 and 2), Neuroimaging findings (Stage 1 and 2), Immunological responses to AAV2 and/or GDNF (Stage 1 and 2)

—

Outcome results

None listed