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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-UMIN000025614 |
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Date of registration:
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01/02/2017 |
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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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Perampanel for sporadic amyotrophic lateral sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial
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Scientific title:
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Perampanel for sporadic amyotrophic lateral sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial - Perampanel for sporadic amyotrophic lateral sclerosis (ALS) |
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Date of first enrolment:
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2017/04/24 |
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Target sample size:
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60 |
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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=R000029464 |
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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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Phase II
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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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Haruhisa
Kato |
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Address:
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Nishishinjuku 6-7-1, Shinjuku-ku, Tokyo, 160-0023, Japan
160-0023
Japan |
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Telephone:
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03-3342-6111 |
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Email:
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h-kato@tokyo-med.ac.jp |
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Affiliation:
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Tokyo Medical University Hospital Department of Neurology |
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Name:
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Hitoshi
Aizawa |
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Address:
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Nishishinjuku 6-7-1, Shinjuku-ku, Tokyo, 160-0023, Japan
Japan |
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Telephone:
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03-3342-6111 |
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Email:
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haizawa@tokyo-med.ac.jp |
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Affiliation:
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Tokyo Medical University Hospital Department of Neurology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: - Patients who underwent tracheostomy. - Patients who experienced non-invasive positive pressure ventilation. - Patients whose percent-predicted forced vital capacity (%FVC) is <80%. - Patients with progressive bulbar palsy type. - Patients with cognitive impairment, severe disease in the renal, cardiovascular, or hematological system. - Patients with hepatic disease. - Patients with malignant tumor. - Pregnant women or women with a possibility of becoming pregnant. - Patients who participated in another clinical study within 12 weeks before starting the observation period. - Patients who has initiated perampanel therapy in the past or at present. - Patients who are judged to be ineligible for study entry by the investigators.
Age minimum:
40years-old
Age maximum:
78years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Sporadic amyotrophic lateral sclerosis
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Intervention(s)
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Once daily perampanel with dose-escalation tolerable from 2mg to 4mg for 48 weeks (Interventions)
Once daily perampanel with dose-escalation tolerable from 2mg to 8mg for 48 weeks (Interventions).
Once daily placebo for 48 weeks (Control)
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Primary Outcome(s)
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To evaluate the effect of perampanel on progression of the disease in subjects with ALS, as measured by the ALS Functional Rating Scale -Revised (ALSFRS-R). [Time Frame: 48 weeks.] [Designated as safety issue: Yes]
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Secondary Outcome(s)
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Change in ALSFRS-R slope [Time Frame: Every 12 weeks.] [Designated as safety issue: Yes] Manual Muscle Test (MMT) [Time Frame: Every 12 weeks.] [Designated as safety issue: Yes] Percent-predicted forced vital capacity (%FVC) [Time Frame: Every 12 weeks.] [Designated as safety issue: Yes]
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Secondary ID(s)
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NCT03019419
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Source(s) of Monetary Support
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Japan Medical Association
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Perampanel was given by Eizai.Co.
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Ethics review
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Status: YES
Approval date: 10/04/2017
Contact:
yuki-m@tokyo-med.ac.jp
Tokyo Medical University Hospital
03-3342-6111
yuki-m@tokyo-med.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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23/12/2020 |
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URL:
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