Trial intelligence / Profile preview

Open-label Extension Study of Mexiletine (Namuscla) in Paediatric Myotonic Disorders

2024-513484-89-00Phase 4Completed

Sponsor
Lupin Limited
Start
Nov 2024
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
Countries
1
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Overview

Phase 4, open-label, single-arm trial of fresolimumab in non-dystrophic myotonia (NDM), myotonic dystrophy type 1 (DM1), myotonic dystrophy type 2 (DM2) and 1 more, sponsored by Lupin Limited. Primary endpoints: Number and frequency of adverse events and serious adverse events, Incidence of adverse events of special interest and 2 more. Started Nov 2024; status: completed.

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Drugs

fresolimumab
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Conditions

non-dystrophic myotonia (NDM)myotonic dystrophy type 1 (DM1)myotonic dystrophy type 2 (DM2)myotonic disorders

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