Trial · NCT07896187
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events | From the time of cell infusion up to 12 months after NCR201 transplantation | To evaluate the safety and tolerability of stereotactic intracerebral injection of NCR201 by assessing the type, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs). |
| Primary | Maximum Tolerated Dose (MTD) of NCR201 | Within 12 months after NCR201 transplantation | Change from baseline in UPDRS Part III motor score to evaluate motor function improvement following NCR201 cell injection. |
| Secondary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score | Baseline, 3 months, 6 months and 12 months after NCR201 transplantation | Change from baseline in UPDRS Part III motor score to evaluate motor function improvement following NCR201 cell injection. |
| Secondary | Survival and engraftment of grafted cells assessed by brain PET/MRI imaging | Baseline, 6 months and 12 months after NCR201 transplantation | Brain PET and MRI imaging to evaluate the survival, location and engraftment of transplanted NCR201 dopaminergic progenitor cells in the putamen. |
| Secondary | Change in UPDRS Part II Activities of Daily Living Score | Baseline, 3 months, 6 months and 12 months after NCR201 transplantation | Change from baseline in UPDRS Part II score to assess activities of daily living in Parkinson's subjects after NCR201 treatment. |
| Secondary | Change in levodopa equivalent daily dose (LEDD) | Baseline, 3 months, 6 months and 12 months after NCR201 transplantation | Change from baseline in levodopa equivalent daily dose (LEDD) to assess reduction of anti-parkinson medication requirement. |
| Secondary | Change in UPDRS Part I Non-motor Experiences of Daily Living Score | Baseline, 3 months, 6 months and 12 months after NCR201 transplantation | Change from baseline in UPDRS Part I score to evaluate non-motor symptoms in Parkinson's patients receiving NCR201. |
| Secondary | Incidence of anti-NCR201 alloantibody formation | Baseline, 1 month, 3 months, 6 months and 12 months after NCR201 transplantation | Detection of anti-donor alloantibodies in peripheral blood to assess immune response against transplanted NCR201 cells. |
| Secondary | Change in Parkinson's Disease Questionnaire (PDQ-39) quality of life score | Baseline, 6 months and 12 months after NCR201 transplantation | Change from baseline in PDQ-39 total score to evaluate health-related quality of life after NCR201 cell transplantation. |
| Secondary | Change in dyskinesia rating scale score | Baseline, 3 months, 6 months and 12 months after NCR201 transplantation | Change from baseline in dyskinesia rating scale to assess the severity of levodopa-induced dyskinesia. |
| Secondary | Duration of on-time without troublesome dyskinesia | Baseline, 3 months, 6 months and 12 months after NCR201 transplantation | Assessment of daily "on" time without troublesome dyskinesia based on patient diaries after NCR201 treatment. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT07896187/registered