Adeno-associated viral vector serotype 2 encoding glial cell line-derived neurotrophic factor (GDNF) for Multiple system atrophy | Parkinson's disease

Inclusion criteria

• {"criterion_text":"- PD and MSA-P participants that are or were enrolled in an interventional AB-1005 study and provide informed consent."}

Exclusion criteria

• {"criterion_text":"- There are no exclusion criteria for this study"}

Primary endpoints

• {"endpoint_text":"- Incidence and severity of AEs (serious and non-serious)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- For PD participants - Normalized PD motor diary times (Good ON, ON with troublesome dyskinesia, OFF)","definition_or_measurement_approach":"Normalized PD motor diary times measured using participant PD motor diaries (Good ON, ON with troublesome dyskinesia, OFF)."}
• {"endpoint_text":"- For PD participants - MDS-UPDRS part III (OFF and ON)","definition_or_measurement_approach":"MDS-UPDRS Part III motor examination assessed in OFF and ON medication states."}
• {"endpoint_text":"- For PD participants - MDS-UPDRS part II (OFF and ON)","definition_or_measurement_approach":"MDS-UPDRS Part II self-reported activities of daily living assessed in OFF and ON states."}
• {"endpoint_text":"- For PD participants - MDS-UPDRS part I","definition_or_measurement_approach":"MDS-UPDRS Part I non-motor experiences of daily living assessment."}
• {"endpoint_text":"- For PD participants - MDS-UPDRS part IV","definition_or_measurement_approach":"MDS-UPDRS Part IV motor complications assessment."}
• {"endpoint_text":"- For PD participants - Levodopa equivalent daily dose (LEDD)","definition_or_measurement_approach":"Calculated levodopa equivalent daily dose (LEDD) from concomitant Parkinson's medications."}
• {"endpoint_text":"- For PD participants - 18F-DOPA PET","definition_or_measurement_approach":"18F-DOPA PET imaging as specified in protocol."}
• {"endpoint_text":"- For MSA participants - UMSARS parts I, II (ON), III, IV","definition_or_measurement_approach":"Unified Multiple System Atrophy Rating Scale (UMSARS) assessments (parts I, II (ON), III, IV)."}
• {"endpoint_text":"- For MSA participants - MSA-QoL","definition_or_measurement_approach":"Multiple System Atrophy Quality of Life (MSA-QoL) questionnaire."}

Poland

Earliest CTIS Part Ii Submission Date

17-11-2025

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

126

Number Of Sites

2

Number Of Participants

40

Primary sponsor

Full Name

Askbio Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Third parties

• {"country":"Germany","full_name":"Bayer AG","duties_or_roles":"Sponsor duties codes: 1,10,11,12,13,5,6,7,8,9; contact clinical-trials-contact@bayer.com","organisation_type":"Pharmaceutical company"}