DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
2	筋萎縮性側索硬化症	1

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04326283 (ClinicalTrials.gov)	April 2, 2020	24/3/2020	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	Amyotrophic Lateral Sclerosis	Drug: Trametinib (0.5 mg);Drug: Trametinib (1 mg);Drug: Trametinib (2 mg);Drug: Riluzole (100 mg)	Genuv Inc.	NULL	Recruiting	19 Years	75 Years	All	30	Phase 1;Phase 2	Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04326283
(ClinicalTrials.gov)

April 2, 2020

24/3/2020

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

Amyotrophic Lateral Sclerosis

Drug: Trametinib (0.5 mg);Drug: Trametinib (1 mg);Drug: Trametinib (2 mg);Drug: Riluzole (100 mg)

Genuv Inc.

NULL

Recruiting

19 Years

75 Years

All

Phase 1;Phase 2

Korea, Republic of