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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02176733 |
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Date of registration:
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25/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Trial of Cyclosporine in the Acute Phase of Leber Hereditary Optic Neuropathy
CICLO-NOHL |
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Scientific title:
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Date of first enrolment:
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July 2011 |
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Target sample size:
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12 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02176733 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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D Milea |
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Address:
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Telephone:
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Email:
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damilea@chu-angers.fr |
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Affiliation:
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Name:
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D Milea |
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Address:
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Telephone:
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Email:
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damilea@chu-angers.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patient with the mutation confirmed by molecular analysis
- patient with a recent loss of monocular vision (= 6 months)
- voluntarily Patient Consent
Exclusion Criteria:
- patient who have not given their written and informed consent signed
- against indication of cyclosporine
- no drug compliance to previous inclusion
- no national health insurance affiliation
- pregnant women or lactating
- women who could become pregnant during the study period and with no contraception
- private patients of their liberty by judicial or administrative decision, or patients
under supervision
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Leber Hereditary Optic Neuropathy
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Intervention(s)
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Drug: cyclosporine
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Primary Outcome(s)
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Measurement of visual acuity with Monoyer, Early Treatment Diabetic Retinopathy Study and Parinaud scales
[Time Frame: at 9 months]
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Secondary ID(s)
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PHRC 2010-05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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