臨床研究等提出・公開システム

Intravenous Immunoglobulin Therapy for Amyotrophic lateral sclerosis (ALSIvig)

Ivig for ALS (ALSIvig)

Asahina Masato

Kanazawa Medical University Hospital

1-1 Daigaku, Uchinada, Kahoku, Ishikawa

asahina@kanazawa-med.ac.jp

Nakanishi Megumi

Kanazawa Medical University Hospital

1-1 Daigaku, Uchinada, Kahoku, Ishikawa

+81-76-286-2211

neurol@kanazawa-med.ac.jp

Complete

May. 23, 2019

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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.

Both

Amyotrophic lateral sclerosis

Treatment of Intravenous immunoglobulin at a dose of 400 mg/kg/day for 5 days.

ALS

Manual muscle test

ALSFRS-R score
grip strength
Respiratory function (%FVC, FVC, EFV)

+81-76-218-8346

No

none