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NCT06880328 · ClinicalTrials.gov registry record · Phase 1
18F-Dihydroxyphenylalanine (DOPA) Positron Emission Tomography (PET) Study to Explore Dopamine Synthesis Capacity in the Whole Striatum After 2 Weeks of Treatment With Ralmitaront or Placebo in Participants With Schizophrenia
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT06880328 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 35 participants.
The verdict
NCT06880328, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
This study is an exploratory proof of mechanism (POM) study using PET/functional magnetic resonance imaging (fMRI) in a 2-period, 2-sequence, crossover design. The aim of the study is to confirm the potential of Ralmitaront to decrease dopamine synthesis capacity (DSC) - as measured by levels of F-DOPA - in the striatum of participants with schizophrenia.
Interventions
- DRUG Placebo
- DRUG Ralmitaront
- OTHER Radiolabeled PET tracer [18F]-DOPA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-11-07 |
| Est. Completion | 2019-09-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06880328
The ClinicalTrials.gov registry entry for NCT06880328 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT06880328 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06880328 about?
NCT06880328 is a clinical study titled "18F-Dihydroxyphenylalanine (DOPA) Positron Emission Tomography (PET) Study to Explore Dopamine Synthesis Capacity in the Whole Striatum After 2 Weeks of Treatment With Ralmitaront or Placebo in Participants With Schizophrenia". This study is an exploratory proof of mechanism (POM) study using PET/functional magnetic resonance imaging (fMRI) in a 2-period, 2-sequence, crossover design. The aim of the study is to confirm the potential of Ralmitaront to decrease dopamine synthesis capacity (DSC) - as measured by levels of F-D...
What is the current status of trial NCT06880328?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2018-11-07. Estimated completion is 2019-09-04.
What interventions are being tested in trial NCT06880328?
The interventions under investigation include: Placebo (DRUG), Ralmitaront (DRUG), Radiolabeled PET tracer [18F]-DOPA (OTHER).
Who is sponsoring clinical trial NCT06880328?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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