NCT06880328

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

18F-Dihydroxyphenylalanine (DOPA) Positron Emission Tomography (PET), Randomized, Double-blind, Crossover Study to Explore Dopamine Synthesis Capacity in the Whole Striatum After 2 Weeks of Treatment With 150mg of RO6889450 or Placebo in Patients With Schizophrenia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Ralmitaront	Participants were given a once 150 mg daily dose of Ralmitaront orally during the 14 day treatment period.
OTHER	Radiolabeled PET tracer [18F]-DOPA	\[18 F\]-DOPA solution for injection is manufactured by the PET imaging centers according to specifications established for the tracer at the site. The injection will happen prior to the scan being done and will last for approximately 30 seconds.
DRUG	Placebo	Participants were given a daily dose of the placebo during the 14 day treatment period.

Timeline

• Start date: 2018-11-07
• Primary completion: 2019-09-04
• Completion: 2019-09-04
• First posted: 2025-03-17
• Last updated: 2025-03-17

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study