Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS)
NCT04326283 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2023-05-09
Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of trametinib (SNR1611) in the treatment of amyotrophic lateral sclerosis.
Conditions
Interventions
- DRUG
-
Trametinib (0.5 mg)
0.5 mg/day
- DRUG
-
Trametinib (1 mg)
1 mg/day
- DRUG
-
Riluzole (100 mg)
100 mg/day (50 mg twice)
Sponsors & Collaborators
-
Genuv Inc.
lead INDUSTRY
Principal Investigators
-
Byoung Joon Kim · Samsung Medical Center, Seoul, Republic of Korea
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-04-02
- Primary Completion
- 2023-04-28
- Completion
- 2023-04-28
Countries
- South Korea
Study Locations
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