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Expanded Access Program for Idebenone in Patients With Leber’s Hereditary Optic Neuropathy Who Completed the LEROS Study

Studies

Study First Submitted Date 2020-05-05
Study First Posted Date 2020-05-08
Last Update Posted Date 2023-04-21
Verification Month Year April 2023
Verification Date 2023-04-30
Last Update Posted Date 2023-04-21

Detailed Descriptions

Sequence: 20639429
Description see above

Browse Interventions

Sequence: 95644918 Sequence: 95644919 Sequence: 95644920 Sequence: 95644921 Sequence: 95644922
Mesh Term Idebenone Mesh Term Antioxidants Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Protective Agents Mesh Term Physiological Effects of Drugs
Downcase Mesh Term idebenone Downcase Mesh Term antioxidants Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term protective agents Downcase Mesh Term physiological effects of drugs
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 51957987
Name Leber’s Hereditary Optic Neuropathy
Downcase Name leber’s hereditary optic neuropathy

Id Information

Sequence: 39993096
Id Source org_study_id
Id Value SNT-EAP-IDE-004

Interventions

Sequence: 52270301
Intervention Type Drug
Name Idebenone 150 MG Oral Tablet
Description idebenone 900 mg/day

Browse Conditions

Sequence: 192641759 Sequence: 192641760 Sequence: 192641761 Sequence: 192641762 Sequence: 192641763 Sequence: 192641764 Sequence: 192641765 Sequence: 192641766 Sequence: 192641767 Sequence: 192641768 Sequence: 192641769 Sequence: 192641770 Sequence: 192641771
Mesh Term Optic Nerve Diseases Mesh Term Optic Atrophy, Hereditary, Leber Mesh Term Nervous System Diseases Mesh Term Cranial Nerve Diseases Mesh Term Eye Diseases Mesh Term Optic Atrophies, Hereditary Mesh Term Optic Atrophy Mesh Term Heredodegenerative Disorders, Nervous System Mesh Term Neurodegenerative Diseases Mesh Term Eye Diseases, Hereditary Mesh Term Genetic Diseases, Inborn Mesh Term Mitochondrial Diseases Mesh Term Metabolic Diseases
Downcase Mesh Term optic nerve diseases Downcase Mesh Term optic atrophy, hereditary, leber Downcase Mesh Term nervous system diseases Downcase Mesh Term cranial nerve diseases Downcase Mesh Term eye diseases Downcase Mesh Term optic atrophies, hereditary Downcase Mesh Term optic atrophy Downcase Mesh Term heredodegenerative disorders, nervous system Downcase Mesh Term neurodegenerative diseases Downcase Mesh Term eye diseases, hereditary Downcase Mesh Term genetic diseases, inborn Downcase Mesh Term mitochondrial diseases Downcase Mesh Term metabolic diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48119931
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Santhera Pharmaceuticals

Eligibilities

Sequence: 30639923
Gender All
Minimum Age N/A
Maximum Age N/A
Criteria Inclusion Criteria: Patients who completed the LEROS study, who attended the end of study visit in LEROS and who in the opinion of investigator could benefit from continuation of idebenone treatment. Signed and dated Informed Consent Form (to be obtained at the Enrollment Visit from patient or parent/legal guardian (if applicable) prior to dispensing idebenone to the patient). Exclusion Criteria: Patients who, in the opinion of the LEROS investigator, had unacceptable tolerability of idebenone treatment in LEROS trial. Patients who prematurely discontinued the LEROS study.
Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254174662
Registered In Calendar Year 2020
Were Results Reported False
Has Single Facility False

Responsible Parties

Sequence: 28753444
Responsible Party Type Sponsor