Other Clinical Trial - Study With Idebenone in Patients NCT01495715

Updated 06/21/2024

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number	NCT01495715
Other study ID #	SNT-III-011
Secondary ID
Status	Withdrawn
Phase	Phase 3
First received	December 16, 2011
Last updated	August 21, 2014

Study information
Verified date	August 2014
Source	Santhera Pharmaceuticals
Contact	n/a
Is FDA regulated	No
Health authority	United States: Food and Drug Administration
Study type	Interventional

Clinical Trial Summary

The objective of the study is to determine whether administration of idebenone can shorten the time to improvement of visual acuity in patients with chronic vision loss due to LHON.

Recruitment information / eligibility
Status	Withdrawn
Enrollment	0
Est. completion date
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	10 Years to 65 Years
Eligibility	Inclusion Criteria: - Age > or equal 10 years and < 65 years - Impaired visual acuity in affected eyes due to LHON: Visual acuity in best eye >0.4 logMAR - No explanation for visual loss besides LHON Exclusion Criteria: - Any previous use of idebenone - Participation in another clinical trial of any investigational drug within 3 months prior to Baseline - Previous participation in Study SNT-II-003 (RHODOS) for idebenone.

Study Design

N/A

Related Conditions & MeSH terms

Leber's Hereditary Optic Neuropathy
Optic Atrophy, Hereditary, Leber
Optic Nerve Diseases

Intervention

Drug:
• Idebenone

• Placebo

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Santhera Pharmaceuticals

See also
	Status	Clinical Trial	Phase
	Completed	`NCT01421381` - RHODOS Follow-up Single-visit Study	N/A
	Completed	`NCT00747487` - Study to Assess Efficacy,Safety and Tolerability of Idebenone in the Treatment of Leber's Hereditary Optic Neuropathy	Phase 2
	Completed	`NCT04909398` - Pupil Dynamics and Color Vision for the Detection of Eye Diseases	N/A
	Completed	`NCT02693119` - A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy	Phase 2
	Active, not recruiting	`NCT02161380` - Safety Study of an Adeno-associated Virus Vector for Gene Therapy of Leber's Hereditary Optic Neuropathy	Phase 1
	No longer available	`NCT02300753` - Emergency Administration of EPI-743 to a Single Patient With Leber's Hereditary Optic Neuropathy [LHON]	N/A
	No longer available	`NCT04381091` - Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study