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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 is a Phase 2 study that has completed, run by Clene Nanomedicine. The registered enrollment target is 13 participants.

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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).

Interventions

  • DRUG Gold Nanocrystals

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2019-12-19
Est. Completion 2021-06-07
Phase Phase 2

Sponsor

Clene Nanomedicine

3 total trials

What the Registry Record Tells You About NCT03815916

The ClinicalTrials.gov registry entry for NCT03815916 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Clene Nanomedicine, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Gold Nanocrystals is the first listed.

NCT03815916 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.