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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-UMIN000008527 |
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Date of registration:
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25/07/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of efficacy and safety of NDDPX08 in ALS patients
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Scientific title:
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Study of efficacy and safety of NDDPX08 in ALS patients - NDDPX08-ALS clinical research |
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Date of first enrolment:
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2009/01/01 |
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Target sample size:
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50 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005640 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Joh-E Ikeda |
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Address:
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143 Shimokasuya, Isehara-shi, Kanagawa
Japan |
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Telephone:
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0463-93-1121 |
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Email:
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joh-e@mgcheo.med.uottawa.ca |
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Affiliation:
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Tokai University School of Medicine Department of Molecular Life Sciences Basic Medical Science and Molecular Medicine |
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Name:
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Joh-E Ikeda |
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Address:
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143 Shimokasuya, Isehara-shi, Kanagawa
Japan |
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Telephone:
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0463-91-5014 |
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Email:
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joh-e@mgcheo.med.uottawa.ca |
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Affiliation:
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Tokai University School of Medicine Department of Molecular Life Sciences Basic Medical Science and Molecular Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Patients diagnosed as having ALS and satisfying all of the following
Age minimum:
20years-old
Age maximum:
75years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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For patients who begin to receive Rilutek treatment at the start or 4 weeks before the start of the observation period, the 12-week treatment with Rilutek alone (100 mg/day) during the observation period is followed by combined treatment (Rilutek + NDDPX08). The NDDPX08 dose level begins at 1.25 mg/day and is increased in steps to 15 mg/day during the 12-week treatment period according to the dose escalation schedule given on the next page (Fig. 1). If any serious adverse reaction arises following a dose increase to 10 mg/day and it is judged to be difficult to maintain this dose level, the dose level of 7.5 mg/day is regarded as the maintenance dose level. If alleviation of symptoms is noted during dose escalation steps, the dose level producing alleviation of symptoms is used as the maintenance dose level. The total NDDPX08 treatment period is 58-90 weeks (including the 4 weeks during which the dose level is reduced in steps). Follow-up of adverse events is continued until 1 month after the end of NDDPX08 treatment.
Placebo (lactose) is administered to 10 of the 50 subjects planned to be enrolled in the study.
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Primary Outcome(s)
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Statistical analysis of efficacy data at the end of the study is assigned to an outside contractor. The information about the subjects assigned to the active drug treatment and placebo groups is disclosed at the time of statistical analysis. Statistical analysis as to the efficacy of the test drug is carried out in comparison to the efficacy data from the placebo group, the time course of variables relative to estimates at the end of the 12-week observation period and the natural history of the disease. The ALS Treatment Plan Evaluation Committee evaluates and judges the safety and efficacy of NDDPX08 in patients with ALS on the basis of the results of the statistical analysis.
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Source(s) of Monetary Support
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Health Labour Sciences Research Grant
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Ethics review
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Status: YES
Approval date:
Contact:
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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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