Long-term observational study of Gene Therapy for Parkinson's disease

JRCT ID: jRCT2033220367

Registered date:07/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 07/10/2022
• Target sample size: 12
• Study type: Observational

Outcome(s)

• Primary Outcome: To investigate the long-term tolerability, safety, and efficacy of the study product in patients with Parkinson's disease, after intracerebral administrations of AAV-hAADC-2 into the putamen.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: -Patients who enrolled in the Phase I/II Study of Gene Therapy for Parkinson's disease, and who completed or discontinued the study.

Exclude criteria

-Patients who cannot undergo MRI.
-Individuals who wish to have children, but do not cryopreserve sperm or eggs prior to administration of the investigational product and use them to obtain children.

Related Information

• Primary Sponsor: Nakajima Takeshi
• Secondary Sponsor: Gene Therapy Research Institution Co., Ltd.