Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-02

Study Completion Date

2023-04-28

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability and efficacy of trametinib (SNR1611) in the treatment of amyotrophic lateral sclerosis.

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Detailed Description

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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

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomly assigned 4:1 to receive SNR1611 (0.5, 1 mg) or riluzole as an active comparator. The study will initiate with the first group of patients who will receive SNR1611 (0.5 mg, 8 patients) or riluzole (100 mg, 2 patients), while the initiation of the next dose groups will be decided by the IDMC (Independent Data Monitoring Committee) through safety assessment of the first 4-week periods of prior dose groups.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

K-ALSFRS-R score will be measured by independent outcome assessors.

Study Groups

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Trametinib (0.5 mg)

One tablet of trametinib 0.5 mg per day

Group Type EXPERIMENTAL

Trametinib (0.5 mg)

Intervention Type DRUG

0.5 mg/day

Trametinib (1 mg)

Two tablets of trametinib 0.5 mg per day

Group Type EXPERIMENTAL

Trametinib (1 mg)

Intervention Type DRUG

1 mg/day

Riluzole (100 mg)

One tablet of riluzole 50 mg taken twice per day

Group Type ACTIVE_COMPARATOR

Riluzole (100 mg)

Intervention Type DRUG

100 mg/day (50 mg twice)

Interventions

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Trametinib (0.5 mg)

0.5 mg/day

Intervention Type DRUG

Trametinib (1 mg)

1 mg/day

Intervention Type DRUG

Riluzole (100 mg)

100 mg/day (50 mg twice)

Intervention Type DRUG

Other Intervention Names

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Meqsel SNR1611 Meqsel SNR1611 Yooritek

Eligibility Criteria

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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.

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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No