JRCT ID: jRCT2033260155
Registered date:26/05/2026
Long term Follow up Study of Gene Therapy for Parkinson's disease
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Parkinson's disease |
| Date of first enrollment | 26/05/2026 |
| Target sample size | 12 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | To evaluate the long-term tolerability, safety, and efficacy of intraputaminal administration of an AAV vector expressing AADC, GCH, and TH in patients with Parkinson's disease. |
|---|---|
| Secondary Outcome | To evaluate the long-term efficacy of intraputaminal administration of an AAV vector expressing AADC, GCH, and TH in patients with Parkinson's disease. |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | Patients who have been enrolled in the Phase I/II clinical trial of GT0003X for Parkinson's disease (Study GT0003X-01) and have either completed or discontinued the said study. |
| Exclude criteria | Patients judged by the investigator or sub-investigator to be ineligible for participation in this study. |
Related Information
| Primary Sponsor | Ohtani Keisuke |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Naoko Yako |
| Address | 3-4-8 Hacchobori, Chuo-ku, Tokyo Tokyo Japan 104-0032 |
| Telephone | +81-3-5543-0306 |
| pd3_gt0003x@cro-srd.co.jp | |
| Affiliation | SRD, Inc. |
| Scientific contact | |
| Name | Keisuke Ohtani |
| Address | 3311-1,Yakushiji, Shimotsuke-shi, Tochigi Tochigi Japan 329-0498 |
| Telephone | +81-285-44-2111 |
| m01011ko@jichi.ac.jp | |
| Affiliation | Jichi Medical University Hospital |