Ivig for ALS

Not Applicable

• Conditions: Amyotrophic lateral sclerosis; ALS

• Registration Number: JPRN-jRCTs041190028
• Lead Sponsor: Asahina Masato

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients diagnosed with sporadic or familial ALS corresponding to the Awaji criteria categories of possible, probable, or definite.
2. Patients rated as 1, 2, or 3 according to Japan ALS severity classification.
3. Patients within 2 years of the initial diagnosis.
4. Patients whose age is from 30-80 years.
5. Patients who have given written consent to participate in this study after receiving sufficient explanation.

Exclusion Criteria

1. Patients diagnosed with multifocal motor neuropathy.
2. Patients predominantly exhibiting bulbar symptoms.
3. Patients with < 70% forced vital capacity.
4. Patients who refuse or are unable to undergo a lumbar puncture.
5. Patients who started to take, discontinued, or changed the dosage of riluzole within 4 weeks prior to giving informed consent to inclusion in the study.
6. Patients receiving or discontinued edaravone therapy within 4 weeks prior to giving informed consent.
7. Patients with a neuroimmunological disease, including MS, MG, and CIDP.
8. Patients with a past history of angina pectoris, myocardial infarction, or heart failure.
9. Patients complicated by or receiving treatment for malignancy or infectious disease.
10. Patients with a manual muscle testing score of 5 (normal strength) for 36 muscles.
11. Patients with IgA deficiency.
12. Patients with past history of hypersensitivity to Venoglobulin IH.
13. Patients who received any other investigational agent within 12 weeks prior to giving informed consent.
14. Patients determined to be unsuitable for the study by the primary investigator or a sub-investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified