Neuronal conduction along the visual patways after oral treatment with Acetyl-L-carnitine in patients with Leber’s Hereditary Optic Neuropathy - Acetyl-L-carnitine on Leber’s Optic Neuropathy

• Register: EUCTR
• Last refreshed on: 13 June 2016
• Main ID: EUCTR2009-016982-26-IT
• Date of registration: 07/02/2011
• Prospective Registration: No
• Primary sponsor: SIGMA-TAU
• Public title: Neuronal conduction along the visual patways after oral treatment with Acetyl-L-carnitine in patients with Leber’s Hereditary Optic Neuropathy - Acetyl-L-carnitine on Leber’s Optic Neuropathy
• Scientific title: Neuronal conduction along the visual patways after oral treatment with Acetyl-L-carnitine in patients with Leber’s Hereditary Optic Neuropathy - Acetyl-L-carnitine on Leber’s Optic Neuropathy
• Date of first enrolment: 04/11/2010
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016982-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Italy

Key inclusion & exclusion criteria

Inclusion criteria:
Age > 20 years and < 60 years; Diagnosis of Leber’s optic neuropathy assessed by the presence of at least one of the three most common LHON pathogenic mutations (11778/ND4, 3460/ND1, 14484/ND6); Duration of disease greater than 2 years; Ganglion cell function evaluable by a PERG response with signal to noise ratio greater than 3. Absence of previous history of retinal or optic nerve diseases; Absence of moderate to dense lens and/or corneal opacities; Snellen best corrected visual acuity of 1/50 or better with a refractive error between -6.00 and +6.00 spherical equivalent; Intraocular pressure less than 21 mmHg; Suspension of Ubiquinone and/or its derivatives for at least 3 months prior to enrolment; Suspension of L-Carnitine and/or its esters for at least 3 months prior to enrolment; For female patient of childbearing potential: usage of a medically accepted method of birth control; Signed Informed Consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Leber’s Hereditary Optic Neuropathy
MedDRA version: 9.1 Level: LLT Classification code 10061323

Intervention(s)

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
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): The Primary endpoint of the study is the decrease of Visual evoked potential P100 implicit times and retinocortical times.

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.

Main Objective: To evaluate the effect of Acetyl-L-carnitine on the neural conduction along the visual pathways.

Secondary ID(s)

ST200-ODU-09-01