Study Purpose:
The purpose of this study is to evaluate the safety, tolerability and efficacy of trametinib (SNR1611) in the treatment of amyotrophic lateral sclerosis.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
Trametinib (0.5 mg), Trametinib (1 mg), Riluzole (100 mg)
Placebo:
No
Phase:
Phase 1/Phase 2
Study Chair(s)/Principal Investigator(s):
Byoung Joon Kim, Samsung Medical Center, Seoul, Republic of Korea
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Full Study Summary:
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.
Study Sponsor:
Genuv Inc.
Estimated Enrollment:
23
Estimated Study Start Date:
04 / 02 / 2020
Estimated Study Completion Date:
04 / 28 / 2023
Posting Last Modified Date:
05 / 09 / 2023
Date Study Added to neals.org:
03 / 30 / 2020
Minimum Age:
19 Years
Maximum Age:
75 Years
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.
Inje University Busan Paik Hospital
Busan
Korea, Republic of
Asan Medical Center
Seoul
Korea, Republic of
Korea University Anam Hospital
Seoul
Korea, Republic of
Samsung Medical Center
Seoul
Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul
Korea, Republic of