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NCT03815916 · ClinicalTrials.gov registry record · Phase 2
31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Parkinson's Disease
A Phase 2 study, sponsored by Clene Nanomedicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT03815916: Completed Phase 2 study, sponsored by Clene Nanomedicine.
NCT03815916 is a Phase 2 study that has completed, run by Clene Nanomedicine. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03815916, a Phase 2 study, has completed, sponsored by Clene Nanomedicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
REPAIR-PD is a single-center open label pilot, sequential group, investigator and patient blinded study to assess the CNS metabolic effects, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in patients who have been diagnosed with Parkinson's Disease (PD) within three (3) years of Screening. The primary endpoint is the ratio of the oxidized to reduced form of nicotinamide adenine dinucleotide (NAD+:NADH) measured non-invasively by 31phosphorous magnetic resonance spectroscopy (31P-MRS).
Primary Outcome
The change in 31P-MRS NAD+/NADH ratio was measured by a partial volume coil that images the parietal and occipital lobes as a single value with respect to the fraction (%) of the nicotinamide adenine dinucleotide (NAD) signal measured as either the oxidized (NAD+) or reduced form (NADH). The primary endpoint was the mean change from Baseline to Week 12 in the ratio of NAD+ to NADH (NAD+/NADH) in the Intent to Treat population. A paired t-test was used to analyze the mean change from baseline.
Interventions
- DRUG Gold Nanocrystals
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2021-06-07 |
| Phase | Phase 2 |
What the finished NCT03815916 record still lists
NCT03815916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Gold Nanocrystals is the first listed.
NCT03815916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03815916 about?
NCT03815916 is a clinical study titled "31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Parkinson's Disease". REPAIR-PD is a single-center open label pilot, sequential group, investigator and patient blinded study to assess the CNS metabolic effects, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in patients who have been diagnosed with Parkinson's Disease (PD) within three (3) years of Screening...
What is the current status of trial NCT03815916?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2019-12-19. Estimated completion is 2021-06-07.
What interventions are being tested in trial NCT03815916?
The interventions under investigation include: Gold Nanocrystals (DRUG).
Who is sponsoring clinical trial NCT03815916?
This trial is sponsored by Clene Nanomedicine, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03815916's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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