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Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study (US EAP LHON)

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ClinicalTrials.gov Identifier: NCT04381091
Expanded Access Status : Available
First Posted : May 8, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Santhera Pharmaceuticals

Brief Summary:
Expanded Access Program for Idebenone in Patients with Leber's Hereditary Optic Neuropathy who completed the LEROS Study

Condition or disease Intervention/treatment
Leber's Hereditary Optic Neuropathy Drug: Idebenone 150 MG Oral Tablet

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
Official Title: Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study



Intervention Details:
  • Drug: Idebenone 150 MG Oral Tablet
    idebenone 900 mg/day

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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): NCT04381091


Contacts
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Contact: Levin, MD, PhD +1-650-596-4220 levinmh@pamf.org

Sponsors and Collaborators
Santhera Pharmaceuticals
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Responsible Party: Santhera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04381091    
Other Study ID Numbers: SNT-EAP-IDE-004
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Optic Nerve Diseases
Optic Atrophy, Hereditary, Leber
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Optic Atrophies, Hereditary
Optic Atrophy
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Mitochondrial Diseases
Metabolic Diseases
Idebenone
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs