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:
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
Inho Seo / email hidden; JavaScript is required / +82-2-542-0318
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:
30
Estimated Study Start Date:
04 / 02 / 2020
Estimated Study Completion Date:
12 / 01 / 2024
Posting Last Modified Date:
09 / 15 / 2022
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 | Recruiting
Seong Il Oh
Busan
Korea, Republic of
Asan Medical Center | Recruiting
Young-Min Lim
Seoul
Korea, Republic of
Korea University Anam Hospital | Recruiting
Byung-Jo Kim
Seoul
Korea, Republic of
Samsung Medical Center | Recruiting
Byoung Joon Kim
Seoul
Korea, Republic of
Severance Hospital, Yonsei University Health System | Recruiting
Ha Young Shin
Seoul
Korea, Republic of