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| Name | Class |
|---|---|
| European Georges Pompidou Hospital | OTHER |
| CLAIROP | UNKNOWN |
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Study of the efficiency of Béfizal® 200 mg in 14 adult patients with a LHON that occurred for less than 5 years. Patient must have certain specific mutations
Study of the efficiency of Béfizal® 200 mg in 14 adult patients in whom the diagnosis of LHON obtained on anamnestic, clinical and ancillary testing / laboratory data. LHON should have occurred for less than 5 years and must be genetically proved with a 3460 or 11778 mitochondrial DNA mutation. Given the mode of transmission, genetic research may have been carried out in a maternal relative
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | 14 adult patients in whom the diagnosis of LHON obtained on anamnestic, clinical and ancillary testing / laboratory data. LHON should have occurred for less than 5 years and must be genetically proved with a 3460 or 11778 mitochondrial DNA mutation. Given the mode of transmission, genetic research may have been carried out in a maternal relative. Befizal® 200 mg will be tested for one year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Béfizal | Drug | 600 mf befizal a day for one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of best corrected farsight visual acuity (in LogMAR) | Measurement of the best corrected farsight visual acuity by Early Treatment Diabetic Retinopathy Study type scale (range from -0.3 to 2.6) -0.3 is the best vision and 2.6 the worse | Month12 |
| Measure | Description | Time Frame |
|---|---|---|
| Farsight best corrected visual acuity | Measurement of the Farsight best corrected visual acuity in LogMAR by Early Treatment Diabetic Retinopathy Study type scale (range from -0.3 to 2.6) -0.3 is the best vision and 2.6 the worse | Month 3 |
| Evolution of Farsight best corrected visual acuity |
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Inclusion Criteria:
Exclusion Criteria:
* Any optic neuropathy for which the diagnosis of LHON is not formally confirmed or genetically proven;
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| Name | Affiliation | Role |
|---|---|---|
| Dominique Bremond Gignac, MD PhD | Necker Hopsital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HEGP Hospital | Paris | 75015 | France |
Undecided
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| ID | Term |
|---|---|
| D001629 | Bezafibrate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D058607 | Fibric Acids |
| D058610 |
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open
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Measurement of the Farsight best corrected visual acuity in LogMAR by Early Treatment Diabetic Retinopathy Study type scale (range from -0.3 to 2.6) -0.3 is the best vision and 2.6 the worse |
| Month 6 |
| Evolution of Farsight best corrected visual acuity | Measurement of the Farsight best corrected visual acuity in LogMAR by Early Treatment Diabetic Retinopathy Study type scale (range from -0.3 to 2.6) -0.3 is the best vision and 2.6 the worse | Month 9 |
| Evolution of Farsight best corrected visual acuity | Measurement of the Farsight best corrected visual acuity in LogMAR by Early Treatment Diabetic Retinopathy Study type scale (range from -0.3 to 2.6) -0.3 is the best vision and 2.6 the worse | Month 15 |
| Evolution of Farsight best corrected visual acuity | Measurement of the Farsight best corrected visual acuity by Early Treatment Diabetic Retinopathy Study type scale (range from -0.3 to 2.6) -0.3 is the best vision and 2.6 the worse | Month 3 |
| Evolution of Farsight decimal best corrected visual acuity | Measurement of the Farsight best corrected visual acuity (in LogMAR) measured with a Monoyer scale (range from 20/20 to light perception). 20/20 is the best vision and light perception the worse | Month 6 |
| Evolution of Farsight decimal best corrected visual acuity | Measurement of the Farsight best corrected visual acuity (in LogMAR) measured with a Monoyer scale (range from 20/20 to light perception). 20/20 is the best vision and light perception the worse | Month 9 |
| Evolution of Farsight decimal best corrected visual acuity | Measurement of the Farsight best corrected visual acuity (in LogMAR) measured with a Monoyer scale (range from 20/20 to light perception). 20/20 is the best vision and light perception the worse | Month 12 |
| Evolution of Farsight decimal best corrected visual acuity | Measurement of the Farsight best corrected visual acuity (in LogMAR) measured with a Monoyer scale (range from 20/20 to light perception). 20/20 is the best vision and light perception the worse | Month 15 |
| Evolution of Nearsight visual acuity | Measurement of the best corrected nearsight visual acuity measured using a Parinaud scale (from P48 to P1>.5) P48 is the worse vision and P1.5 the best | Month 3 |
| Evolution of Nearsight visual acuity | Measurement of the best corrected nearsight visual acuity measured using a Parinaud scale (from P48 to P1>.5) P48 is the worse vision and P1.5 the best | Month 6 |
| Evolution of Nearsight visual acuity | Measurement of the best corrected nearsight visual acuity measured using a Parinaud scale (from P48 to P1>.5)P48 is the worse vision and P1.5 the best | Month 9 |
| Evolution of Nearsight visual acuity | Measurement of the best corrected nearsight visual acuity measured using a Parinaud scale (from P48 to P1>.5) P48 is the worse vision and P1.5 the best | Month 12 |
| Evolution of Nearsight visual acuity | Measurement of the best corrected nearsight visual acuity measured using a Parinaud scale (from P48 to P1>.5) P48 is the worse vision and P1.5 the best | Month 15 |
| Evolution of retinal nerve fibers layer Optical Coherent Tomography | physiological parameter : Optical Coherent Tomography | Month 6 |
| Evolution of retinal nerve fibers layer Optical Coherent Tomography | physiological parameter : Optical Coherent Tomography | Month 12 |
| automated visual field measurement | physiological parameter : automated visual field corrected deviation of a visual field, measured according to a protocol STAT protocol 30 (Champ visuel Métrovision, Perenchies, France) | Month 3 |
| automated visual field measurement | physiological parameter : automated visual field | Month 6 |
| automated visual field | physiological parameter : automated visual field corrected deviation of a visual field, measured according to a protocol STAT protocol 30 (Champ visuel Métrovision, Perenchies, France) | Month 9 of a treatment with BEFIZAL® 200mg (ARROW GENERIQUES) compare to Month 0 |
| automated visual field measurement | physiological parameter : automated visual field corrected deviation of a visual field, measured according to a protocol STAT protocol 30 (Champ visuel Métrovision, Perenchies, France) | Month 12 |
| automated visual field measurement | physiological parameter : automated visual field corrected deviation of a visual field, measured according to a protocol STAT protocol 30 (Champ visuel Métrovision, Perenchies, France) | Month 15 |
| Manual visual field measurement | physiological parameter : manual visual field measured with isopters V / 4, III / 1 and II / 1 | Month 3 |
| Manual visual field measurement | physiological parameter : manual visual field measured with isopters V / 4, III / 1 and II / 1 | Month 6 |
| Manual visual field measurement | physiological parameter : manual visual field measured with isopters V / 4, III / 1 and II / 1 | Month 9 |
| Manual visual field measurement | physiological parameter : manual visual field measured with isopters V / 4, III / 1 and II / 1 | Month 12 |
| Manual visual field measurement | physiological parameter : manual visual field measured with isopters V / 4, III / 1 and II / 1 | Month 15 |
| National Eye Institute Visual Function Questionnaire 25 | Questionnaire | Month 12 |
| Concentration of serum creatinine | Concentration of serum creatinine | Every three months until Month 15 |
| Concentration of high-density lipoprotein cholesterol | Blood test | Every three months until Month 15 |
| Concentration of very low-density lipoprotein cholesterol | Blood test | Every three months until Month 15 |
| Concentration of triglycerides | Blood test | Every three months until Month 15 |
| Rate of Partial thromboplastin time | Blood test | Every three months until Month 15 |
| Concentration of Aspartate aminotransférase | Blood test | Every three months until Month 15 |
| Concentration of Alanine aminotransférase | Blood test | Every three months until Month 15 |
| Concentration of lactate deshydrogenase | Blood test | Every three months until Month 15 |
| Concentration of creatine kinase | Blood test | Every three months until Month 15 |
| Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002723 | Chlorobenzoates |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |