Leber’s Hereditary Optic Neuropathy MedDRA version: 9.1 Level: LLT Classification code 10061323
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Acetylcarnitine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Tablet
Rou
Sponsors
SIGMA-TAU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age > 20 years and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Presence of concomitant ocular pathology as moderate to dense lens and/or corneal opacities (cataract, corneal leucoma), retinal diseases (age-related maculopathy, retinal detachment, retinal schisis), other type of optic nerve diseases (glaucoma, optic neuropathy); Presence of any serious chronic disease (cancer, disabiliting chronic infections, heart, liver or kidney diseases) which would suggest the exclusion of the patient and would interfere with the results of the study; Suspected or known hypersensitivity to Carnitine and/or its esters; Treatment with Ubiquinone and/or its derivatives within 3 months prior to enrolment; Treatment with L-Carnitine and/or its esters within 3 months prior to enrolment; Suspected or known pregnancy and/or breast feeding; Participation in another clinical trial of any investigational drug within 3 months prior to enrolment; Signed informed Consent refusal or disability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of Acetyl-L-carnitine on the neural conduction along the visual pathways.;Secondary Objective: To evaluate the effect of Acetyl-L-carnitine on retinal ganglion cells function, visual acuity and visual field. To evaluate tolerability and safety of Acetyl-L-carnitine.;Primary end point(s): The Primary endpoint of the study is the decrease of Visual evoked potential P100 implicit times and retinocortical times. | — |
Countries
Italy
Outcome results
None listed