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NCT04928287 · ClinicalTrials.gov registry record · Phase 2
Randomized, Double-Blind Clinical Trial for Parkinson's Disease (Early and Moderate)
A Phase 2 study of Parkinson Disease, sponsored by Hope Biosciences Research Foundation.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04928287: Completed Phase 2 study of Parkinson Disease, sponsored by Hope Biosciences Research Foundation.
NCT04928287 is a Phase 2 study of Parkinson Disease that has completed, run by Hope Biosciences Research Foundation. The registered enrollment target is 24 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04928287, a Phase 2 study of Parkinson Disease, has completed, sponsored by Hope Biosciences Research Foundation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, double-blind, single center, phase 2 study to assess efficacy and safety of multiple HB-adMSCs vs Placebo for the treatment of Parkinson's disease. The trial includes a screening period of up to 4 weeks, a 32-week treatment period, and a safety Follow-up period of 20 weeks after the last investigational product administration. This clinical trial will be open to enroll 24 eligible participants diagnosed with Parkinson's disease. Patients' recruitment will be conducted by the study team, if eligible participants are identified based on eligibility criteria, a screening visit will be scheduled. Informed consent form will be given to the study participants and signed before any study procedures. Informed consent form will include information about the clinical trial and some aspects should be considered during this process.
Primary Outcome
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included i
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL HB-adMSCs
Study Locations (1)
Texas
- Hope Biosciences Stem Cell Research Foundation - Sugar Land
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-06-28 |
| Est. Completion | 2023-02-06 |
| Phase | Phase 2 |
What the finished NCT04928287 record still lists
NCT04928287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04928287 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04928287 about?
NCT04928287 is a clinical study titled "Randomized, Double-Blind Clinical Trial for Parkinson's Disease (Early and Moderate)". This is a randomized, double-blind, single center, phase 2 study to assess efficacy and safety of multiple HB-adMSCs vs Placebo for the treatment of Parkinson's disease. The trial includes a screening period of up to 4 weeks, a 32-week treatment period, and a safety Follow-up period of 20 weeks aft...
What is the current status of trial NCT04928287?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2021-06-28. Estimated completion is 2023-02-06.
What conditions does trial NCT04928287 study?
This clinical trial studies the following conditions: Parkinson Disease.
What interventions are being tested in trial NCT04928287?
The interventions under investigation include: Placebo (OTHER), HB-adMSCs (BIOLOGICAL).
Who is sponsoring clinical trial NCT04928287?
This trial is sponsored by Hope Biosciences Research Foundation, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04928287 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04928287's enrollment target sits among peer trials
24 232nd of 297 higher than 61 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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