An observational study in Parkinson Disease, sponsored by BlueRock Therapeutics. Enrolling by invitation at 3 sites in 2 countries. Open to participants aged 50 Years to 78 Years. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by BlueRock Therapeutics (part of Bayer) · Observational
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Among 12 studies in Parkinson Disease by Bayer — 6 open to participants now, 8 under way, 1 of them phase 3. Parkinson Disease · Bayer.
Among the 12 studies in Parkinson Disease by Bayer, this one is the only one that started in 2023, is one of 5 observational ones, and was the 6th registered.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
Browse Parkinson Disease studies →6 of the 12 studies in Parkinson Disease by Bayer are open now, in 4 countries. Recruiting first, the newest first:
Bayer · Sites in United States
Ages 45–75
BlueRock Therapeutics · Sites in United States, Australia, Canada
Ages 45–75
AskBio Inc · Sites in United States
Bayer · Sites in Japan
Ages 45–75
AskBio Inc · Sites in United States
Ages 45–75
By country, each count listing its studies:
Of the 750 Parkinson Disease studies recruiting now, 312 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 190 take healthy volunteers.
This study: 50 Years to 78 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 1 started in 2023.
This study's planned enrollment of 12 is below the median of 96 across 1,086 observational studies indexed under Parkinson Disease.
Median enrollment 18 across the 7 interventional studies, 132 across the 5 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
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This study is registered under BlueRock Therapeutics, one of the names counted as Bayer. Under that name alone:
BlueRock Therapeutics is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
1 of the studies in Parkinson Disease by Bayer that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05897957BlueRock TherapeuticsContinued Evaluation of Patients With Parkinson's Disease Who Previously Received BRT-DA01 | 2027-05 |
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Among the 12 studies in Parkinson Disease by Bayer, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a multicenter study to evaluate the safety and clinical outcomes of BRT-DA01 in subjects with PD who previously received BRT-DA01 in the Phase 1 Study MSK-DA01-101.No investigational therapy will be administered in this study.
All subjects who received BRT-DA01 transplantation in Study MSK-DA01-101 (ie, parent study) will be asked to enroll in Study BRT-DA01-501. Subjects enrolled in this study are to be monitored for safety and clinical outcomes through 5 years post-BRT-DA01 transplantation. For individual participating subjects, the Baseline visit for the BRT-DA01-501 study will be defined as the last observation recorded in the parent study.
Advanced Parkinson's Disease who previously received BRT-DA01 in the Phase 1 Study MSK-DA01-101
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Total SAEs and total number of subjects with at least 1 SAE
Total SAEs and total number of subjects with at least 1 SAE related to cellular drug product
Time frame: Baseline through 5 years post-transplantation
Change in striatal 18F-DOPA uptake using positron emission tomography (PET)
Change in striatal 18F-DOPA uptake using positron emission tomography (PET)
Time frame: Baseline through 5 years post-transplantation
Change in Hauser PD diary measurements
Change in Hauser PD diary measurements
Time frame: Baseline through 5 years post-transplantation
Change in the International Parkinson and Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (UPDRS)
Change in the MDS-UPDRS
Time frame: Baseline through 5 years post-transplantation
Change in levodopa equivalent daily dose (LEDD)
Change in LEDD
Time frame: Baseline through 5 years post-transplantation
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) summary index
Change in PDQ-39
Time frame: Baseline through 5 years post-transplantation
Change in the Unified Dyskinesia Rating Scale (UDysRS)
Change in UDysRS
Time frame: Baseline through 5 years post-transplantation
Adverse Events
AEs related to the cellular drug product
Time frame: Baseline through 5 years post-transplantation
Change in modified Schwab and England Activities of Daily Living (mSEADL) scale
Change in mSEADL
Time frame: Baseline through 5 years post-transplantation
Change in brain atrophy using MRI
Change in brain atrophy using MRI
Time frame: Baseline through 5 years post-transplantation
Subjects using alternative advanced treatment options in Parkin's Disease
Number of subjects using alternative advanced treatment options in PD (eg, CSAI, LCIG, DBS, focused ultrasound ablation)
Time frame: Baseline through 5 years post-transplantation
Plan to share: No
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for May 2027, 48 months after the start.
Of 60 industry-sponsored observational studies under Parkinson Disease, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 64. This study's planned 48 months is above that.
Counting every sponsor, half of 439 studies reached it within 47 months; a quarter within 22 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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