Trial of Safety Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS)

  • STATUS
    Recruiting
  • End date
    Dec 5, 2022
  • participants needed
    30
  • sponsor
    GENUV Inc.
Updated on 5 August 2021
primary lateral sclerosis
riluzole

Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of trametinib (SNR1611) in the treatment of amyotrophic lateral sclerosis.

Description

Trametinib (SNR1611) is a MEK inhibitor that downregulates the MAPK/ERK pathway. In this study, the potential of MAPK/ERK pathway downregulation through trametinib (SNR1611) as a therapeutic treatment for amyotrophic lateral sclerosis (ALS) will be evaluated.

Details
Condition Myelopathy, Amyotrophic Lateral Sclerosis, Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Disorders, lou gehrig's disease
Treatment Trametinib (0.5 mg), Trametinib (1 mg), Trametinib (2 mg), Riluzole (100 mg)
Clinical Study IdentifierNCT04326283
SponsorGENUV Inc.
Last Modified on5 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients diagnosed as definite, probable or probable-laboratory-supported ALS according to El Escorial Criteria
Patients of less than 2 years after the onset of ALS
Patients who meet the criteria of K-ALSFRS-R score and forced vital capacity

Exclusion Criteria

Patients with primary lateral sclerosis, progressive muscular atrophy or lower motor neuron disease
Patients who have history of ALS treatment of edaravone or stem cell therapy within 16 weeks before screening
Patients who have permanently ceased the administration of riluzole due to lack of tolerability and/or efficacy
Patients in Class II to IV according to the New York Heart Association functional classification. Patients with myocardial infarction, unstable arrhythmia, and/or significant cardiovascular disease such as unstable angina within 12 weeks before screening
Patients who do not meet the criteria of laboratory tests and medical/operation history
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