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A multi-center randomized, double-blind, placebo-controlled, clinical trail of Idebenone in the treatment of LHON

A multi-center randomized, double-blind, placebo-controlled, clinical trail of Idebenone in the treatment of LHON

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17013821
Enrollment
Unknown
Registered
2017-12-11
Start date
2018-01-10
Completion date
Unknown
Last updated
2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leber’s hereditary optic neuropathy,LHON

Interventions

Control group:to give placebo 150mg/time,3 times/day
control group:Mecobalamin Tablets 0.5mg / time, three times / day
Control group:Vitamin B1 tablets 10mg/ time, three times / day
observation group:to give Idebenone 150mg/time,3 times/day
observation group:Mecobalamin Tablets 0.5mg / time, three times / day
observation group:Vitamin B1 tablets 10mg/ time, three times / day

Sponsors

Beijing Tongren Hospital, CMU
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of LHON in clinical ophthalmology, edited by Kanski; 2. At least one common major mutation :m.G11778Am.T14484Cm.G3460Am.G3635A[10-16] 3. 18 years of age or older; 4. Painless central vision decline and successively common binocular disease,But the interval is less than 1 years duration less than 5 years; 5. the patient or the patients legal representative have provided singed written informed consent.

Exclusion criteria

Exclusion criteria: 1. other diseases that cause optic nerve injury: intracranial tumors, optic neuritis, multiple sclerosis, ischemic, radioactive, toxic and other optic nerve diseases. 2. patients with other ocular diseases that cause visual dysfunction, such as uveitis and irises, etc. 3. serious abnormal liver function (alt, AST AST ALT > 3 times the upper limit of normal reference value); 4. women in pregnancy and lactation; 5. poor compliance and poor compliance.

Design outcomes

Primary

MeasureTime frame
Distribution of visual acuity before and after treatment (including anterior index and anterior hand);The distribution of visual acuity before and after treatment of different loci (recommended by the Wenzhou star Kang standard logarithmic visual acuity chart);

Secondary

MeasureTime frame
Changes of visual field before and after treatment (suggested using Humphrey field of vision);Changes in visual evoked potential (P-VEP) (recommended using German Roland RETI);OCT detection of retinal thickness changes (recommended useing Heidelberg OCT, Germany or Zeiss OCT, Germany);

Countries

China

Contacts

Public ContactWang Jiawei

Beijing Tongren Hospital,CMU

wangjwcq@163.com+86 13651110820

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026