Trial intelligence / Profile preview

OPIDYS-ALS

2025-522546-52-00Phase 3Authorised

Sponsor
Assistance publique - Hôpitaux de Paris
Start
Feb 2026
Modality
Small Molecules
Countries
1
01

Overview

Phase 3, randomised, double-blind trial in amyotrophic lateral sclerosis (ALS) and chronic respiratory failure comparing Sustained-release oral morphine with Placebo (2 arms). Primary endpoints: Change in intensity of dyspnea unpleasantness during the worst dyspneic episode in previous 24 hours at Day 7 and Change in intensity of dyspnea unpleasantness during the worst dyspneic episode in previous 24 hours at 4 weeks. Planned start Feb 2026; status: authorised.

02

Drugs

morphine
03

Conditions

amyotrophic lateral sclerosis (ALS)chronic respiratory failure

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