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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-jRCTs041190028 |
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Date of registration:
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23/05/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Ivig for ALS
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Scientific title:
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Intravenous Immunoglobulin Therapy for Amyotrophic lateral sclerosis - ALSIvig |
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Date of first enrolment:
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18/06/2019 |
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Target sample size:
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30 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCTs041190028 |
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Study type:
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Interventional |
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Study design:
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single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose
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Phase:
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N/A
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Contacts
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Name:
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Megumi
Nakanishi |
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Address:
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1-1 Daigaku, Uchinada, Kahoku, Ishikawa
920-0293
Ishikawa
Japan |
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Telephone:
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+81-76-286-2211 |
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Email:
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neurol@kanazawa-med.ac.jp |
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Affiliation:
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Kanazawa Medical University Hospital |
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Name:
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Masato
Asahina |
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Address:
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1-1 Daigaku, Uchinada, Kahoku, Ishikawa
920-0293
Ishikawa
Japan |
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Telephone:
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+81-76-286-2211 |
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Email:
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asahina@kanazawa-med.ac.jp |
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Affiliation:
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Kanazawa Medical University Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
>= 30age old
Age maximum:
< 80age old
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic lateral sclerosis
ALS
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Intervention(s)
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Treatment of Intravenous immunoglobulin at a dose of 400 mg/kg/day for 5 days.
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Primary Outcome(s)
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Manual muscle test
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Secondary Outcome(s)
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ALSFRS-R score
grip strength
Respiratory function (%FVC, FVC, EFV)
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Source(s) of Monetary Support
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Japan Blood Products Organization
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Ethics review
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Status: Approval
Approval date: 16/05/2019
Contact:
tiken@kanazawa-med.ac.jp
Kanazawa Medical University Clinical Research Review Board
+81-76-218-8346
tiken@kanazawa-med.ac.jp
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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