WHO ICTRP trial

Phase 2 study for SAR443820 in participants with amyotrophic lateral sclerosis…

EUCTR2021-004156-42-NL · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2021-004156-42-NL
Public title Phase 2 study for SAR443820 in participants with amyotrophic lateral sclerosis (ALS)
Scientific title A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR443820 in adult participants with amyotrophic lateral sclerosis, followed by an open-label extension
Primary sponsor Sanofi-aventis recherche & développement
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries United States;Japan;United Kingdom;Spain;Canada;Netherlands;Sweden;Belgium;China;Poland;Italy;France;Germany
Conditions Amyotrophic lateral sclerosis MedDRA version: 21.1 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases…
Interventions Product Code: SAR443820 Pharmaceutical Form: Film-coated tablet CAS Number: 2252271-93-3 Current Sponsor code: SAR443820 Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489 Concentration unit: mg milligram(s)…
Registration date Dec 21, 2021
Target size 261
Secondary IDs ACT16970;2021-004156-42-SE
Registry page clinicaltrialsregister.eu

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