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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-UMIN000017939 |
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Date of registration:
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20/06/2015 |
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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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Multicenter study of therapeutic effects of Idebenone in patients with Leber hereditary optic neuropathy
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Scientific title:
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Multicenter study of therapeutic effects of Idebenone in patients with Leber hereditary optic neuropathy - Clinical trial of Idebenone in patients with LHON |
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Date of first enrolment:
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2013/10/01 |
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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=R000020747 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase I,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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Hiroto
Ishikawa |
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Address:
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1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan 663-8501
6638501
Japan |
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Telephone:
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0798-45-6462 |
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Email:
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ohmyeye@hyo-med.ac.jp |
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Affiliation:
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Hyogo College of Medicine Ophthalmology |
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Name:
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Hiroto
Ishikawa |
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Address:
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1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan 663-8501
Japan |
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Telephone:
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0798-45-6462 |
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Email:
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ohmyeye@hyo-med.ac.jp |
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Affiliation:
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Hyogo College of Medicine Ophthalmology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: a) A smoker b) A patient with abnormality of hepatic function c) A patient who present seizures, delirium and hallucination d) Pregnancy or Lactation e) A patient who is associated with agranulocytosis f) A patient with chronic renal failure g) A patient with anaphylactic shock against Idebenone
Age minimum:
10years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Leber hereditary optic neuropathy
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Intervention(s)
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1. Clinical trial medicine: Idebenone 900mg/day 2. Objectives: 50 patients with LHON 3. Exclusion criteria: a) A smoker b) A patient with abnormality of hepatic function c) A patient who present seizures, delirium and hallucination d) Pregnancy or Lactation e) A patient who is associated with agranulocytosis f) A patient with chronic renal failure g) A patient with anaphylactic shock against Idebenone 4. Duration of drug administration: 6 months 5. Examinations schedules: Both subjective and objective examinations are performed as following schedules; a) At the base line: Visual acuity (VA), Critical flicker frequency (CFF), Visual field (VF: Humphry 30-2), central retinal thickness (CRT), functional MRI (f-MRI), searching the mitochondrial mutation b) 8 weeks: VA, CFF, VF, CRT, f-MRI c) 16 weeks: VA, CFF, VF, CRT, f-MRI d) 24 weeks: VA, CFF, VF, CRT, f-MRI e) 32 weeks: VA, CFF, VF, CRT, f-MRI f) 40 weeks: VA, CFF, VF, CRT, f-MRI g) 48 weeks: VA, CFF, VF, CRT, f-MRI
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Primary Outcome(s)
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Visual acuity (at 12 months after the start of the study drug)
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Secondary Outcome(s)
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Visual acuity (at 6 months after the start of the study drug), Visual field (at 6 and 12 months after the start of the study drug), Critical flicker frequency (at 6 and 12 months after the start of the study drug), central retinal thickness (at 6 and 12 months after the start of the study drug)
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Source(s) of Monetary Support
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Hyogo College of Medicine
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Ethics review
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Status: YES
Approval date: 10/09/2013
Contact:
rinri@hyo-med.ac.jp
IRB, Hyogo College of Medicine
+81798456066
rinri@hyo-med.ac.jp
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