Trials / Terminated
TerminatedNCT04326283
Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS)
A Sequential Dose-Escalation, Randomized, Active-Controlled, Multi-Center, Phase 1/2a Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of SNR1611 in Patients With Amyotrophic Lateral Sclerosis
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Genuv Inc. · Industry
- Sex
- All
- Age
- 19 Years – 75 Years
- Healthy volunteers
- Not accepted
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 for amyotrophic lateral sclerosis (ALS) will be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2020-04-02
- Primary completion
- 2023-04-28
- Completion
- 2023-04-28
- First posted
- 2020-03-30
- Last updated
- 2023-05-09
Locations
5 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04326283. Inclusion in this directory is not an endorsement.