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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GENUV Inc.
• Treatments: Riluzole; Trametinib

Criteria

Main 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.

Main 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.