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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: Completed Phase 1 study, sponsored by Hoffmann-La Roche.

NCT06880328 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 35 participants
Start Date 2018-11-07
Est. Completion 2019-09-04
Phase Phase 1
Hoffmann-La Roche

909 total trials

What the finished NCT06880328 record still lists

NCT06880328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT06880328 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT06880328's enrollment target sits among peer trials

35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other 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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Source: ClinicalTrials.gov NCT06880328, the US trial registry maintained by the National Library of Medicine. NCT06880328 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.