Exploratory clinical study of DF-521 in ALS (2)

Exploratory clinical study of DF-521 in Amyotrophic Lateral Sclerosis(2) - ECSDA2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031180059

Enrollment

Registered

2018-12-20

Start date

2017-10-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis ALS

Interventions

A single treatment cycle consisted of 6 weeks of DF-521 administration period followed by 2 weeks observation period. DF-521 is administered every other day for 6 weeks(18 times in total) in the admin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients who are categorized as either definite or probable ALS according to the revised El Escorial criteria (2)Patients at Grade 3 in Japan ALS severity classification(3)Patients scoring >=1 points on each single ALSFRS-R item(4)Patients with normal respiratory function(%FVC>=60%)(5)Patients with ALS that occurred within 3 years at the time of giving written informed consent(6)Patients aged 20 to 75 years at the time of giving written informed consent(7)Patients who provided written informed consent to participate in the present study

Exclusion criteria

Exclusion criteria: (1)Patients with reduced respiratory function and complaints of dyspnea.Patients scoring==180 mmHg cannot be lowered>=150 mmHg by lowering blood pressure agents (12)Patients undergoing cancer treatment (13)Patients with a history of hypersensitivity to Edaravone if they are going to use Edaravone (14)Patients with a history of hypersensitivity to Batroxobin (15)Patients with severe illness(16)Male patients who do not consent to using reliable contraception methods during the studied period (17)Premenopausal women (18)Patients who has participated in another clinical trial twelve weeks prior to inclusion in this study(19)Patients with renal dysfunction with creatinine clearance of 50mL per min or below(20)Patients who are not eligible due to physician's judgment

Design outcomes

Primary

Measure	Time frame
The change in ALSFRS-R score	—

Secondary

Measure	Time frame
Changes of FVC, grip strength(left/right), pinch strength( left/right), and time to death or a specified state of disease progression	—

Contacts

Public ContactNahoko Iuchi

Tobishi Pharmaceutical Co.,Ltd

n.iuchi@tobishipharm.com+81-3-3213-3784

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026