Ivig for ALS

JRCT ID: jRCTs041190028

Registered date:23/05/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Amyotrophic lateral sclerosis
• Date of first enrollment: 18/06/2019
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Treatment of Intravenous immunoglobulin at a dose of 400 mg/kg/day for 5 days.

Outcome(s)

• Primary Outcome: Manual muscle test

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: < 80age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Asahina Masato
• Source(s) of Monetary Support: Japan Blood Products Organization