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 |