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NCT04616456 · ClinicalTrials.gov registry record · Early Phase 1
Effect of Verdiperstat on Microglial Activation in Well-characterized MSA Patients
A Early Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 19
- Enrollment target
NCT04616456: Completed Early Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT04616456 is a Early Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 19 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04616456, a Early Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This study will comprise of two phases, an observational phase and a treatment phase. In the observational phase the specific aims are: 1. To determine the presence and regional distribution of microglial activation, as assessed by 18F-PBR06 PET, in subjects with MSA as compared to healthy controls, at baseline and at 6-9 months' follow-up. 2\. To assess the relationship between microglial activation and clinical progression at baseline and follow-up. In the treatment phase the specific aims of the study are: The specific aims of the study are: 1. To assess whether verdiperstat (BHV-3241) reduces 18F-PBR06 PET signal, and thus microglial activation and inflammation, in well-characterized MSA patients. 2. To assess the relationship between PET changes and clinical progression at baseline and follow-up in patients treated with verdiperstat. 3. To assess the relationship between PET changes and volumetric brain MRI at baseline and follow-up in patients treated with verdiperstat. Currently there is no known disease modifying therapy for MSA. Recently, the drug verdiperstat (BHV-3241) has appeared in the investigational arena specifically for the indication of Multiple System Atrophy. Verdiperstat (BHV-3241) is currently being used in a phase 3 active drug trial at Massachusetts Hospital. Verdiperstat (BHV-3241) is known to target Myeloperoxidase, an enzyme implicated in neuroinflammation, a major driver in disease pathogenesis. Our previous study (IRB protocol #2016P002373) demonstrated that applying TSPO (translator protein) PET imaging enabled us to track changes in neuroinflammation and thus provide a viable biomarker for disease progression. In this pilot study, the investigators aim to assess the effect of an investigational drug, verdiperstat (BHV-3241) on microglial activation in MSA patients using \[F-18\]PBR06 and to link it with clinical and morphometric MRI brain changes following treatment.
Primary Outcome
PET imaging measurement calculated over whole brain within putamen, pons, cerebellum
Interventions
- DRUG Verdiperstat
- DRUG [F-18]PBR06
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2020-12-30 |
| Est. Completion | 2022-01-30 |
| Phase | Early Phase 1 |
What the finished NCT04616456 record still lists
NCT04616456 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Verdiperstat is the first listed.
NCT04616456 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04616456 about?
NCT04616456 is a clinical study titled "Effect of Verdiperstat on Microglial Activation in Well-characterized MSA Patients". This study will comprise of two phases, an observational phase and a treatment phase. In the observational phase the specific aims are: 1. To determine the presence and regional distribution of microglial activation, as assessed by 18F-PBR06 PET, in subjects with MSA as compared to healthy controls...
What is the current status of trial NCT04616456?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 19 participants. The study started on 2020-12-30. Estimated completion is 2022-01-30.
What interventions are being tested in trial NCT04616456?
The interventions under investigation include: Verdiperstat (DRUG), [F-18]PBR06 (DRUG).
Who is sponsoring clinical trial NCT04616456?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04616456's enrollment target sits among peer trials
19 1292nd of 2000 higher than 686 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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