Status:
TERMINATED
Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Genuv Inc.
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
19-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of trametinib (SNR1611) in the treatment of amyotrophic lateral sclerosis.
Detailed 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04326283
Start Date
April 2 2020
End Date
April 28 2023
Last Update
May 9 2023
Active Locations (5)
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1
Inje University Busan Paik Hospital
Busan, South Korea
2
Asan Medical Center
Seoul, South Korea
3
Korea University Anam Hospital
Seoul, South Korea
4
Samsung Medical Center
Seoul, South Korea