302. レーベル遺伝性視神経症 Leber hereditary optic neuropathy Clinical trials / Disease details


臨床試験数 : 22 薬物数 : 17 - (DrugBank : 4) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 33

  
1 trial found
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1JPRN-UMIN000017939
2013/10/0120/06/2015Multicenter study of therapeutic effects of Idebenone in patients with Leber hereditary optic neuropathyMulticenter study of therapeutic effects of Idebenone in patients with Leber hereditary optic neuropathy - Clinical trial of Idebenone in patients with LHON Leber hereditary optic neuropathy1. 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
Hyogo College of MedicineKitasato UniversityJikei University School of MedicineTokyo Medical UniversityComplete: follow-up complete10years-old80years-oldMale and Female50Phase 1,2Japan