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Trial of Cyclosporine in the Acute Phase of Leber Hereditary Optic Neuropathy (CICLO-NOHL)

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ClinicalTrials.gov Identifier: NCT02176733
Recruitment Status : Unknown
Verified January 2014 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : June 27, 2014
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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Brief Summary:

The Leber Hereditary Optic Neuropathy is a genetic disorder caused by maternal transmission of mitochondrial DesoxiroboNucleid Acid mutations. It is manifested by a rapidly progressive blindness, profound, due to atrophic optic nerve. The visual loss is primarily unilateral bilateralisation taking place in the vast majority of cases in weeks or months. The neuro-cardio-protective properties of cyclosporine (and its analogs specifically targeting the anti-apoptotic mechanisms) are particularly promising.

The investigators hypothesis is that cyclosporine may limit apoptosis during the acute phase of the disease process and would limit the loss of visual acuity and improve the visual prognosis of these patients.


Condition or disease Intervention/treatment Phase
Leber Hereditary Optic Neuropathy Drug: cyclosporine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2011
Estimated Primary Completion Date : October 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: cyclosporine Drug: cyclosporine


Outcome Measures
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Primary Outcome Measures :
  1. Measurement of visual acuity with Monoyer, Early Treatment Diabetic Retinopathy Study and Parinaud scales [ Time Frame: at 9 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176733


Contacts
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Contact: D Milea damilea@chu-angers.fr

Locations
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France
Centre Hospitalier Universitaire Recruiting
Angers, France, 49000
Contact: D Milea       damilea@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02176733    
Other Study ID Numbers: PHRC 2010-05
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: June 27, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Optic Nerve Diseases
Optic Atrophy, Hereditary, Leber
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Optic Atrophies, Hereditary
Optic Atrophy
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Mitochondrial Diseases
Metabolic Diseases
 Cyclosporine
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors