Study With Idebenone in Patients With Chronic Vision Loss... | NCT01495715

Studies
Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)

NCT01495715

Sponsor

Santhera Pharmaceuticals

Status

Withdrawn

Last Update Posted

Aug 22, 2014Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Leber's Hereditary Optic Neuropathy

Interventions

Idebenone
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 16, 2011

First Submission Date that Met QC Criteria

Dec 19, 2011

First Posted Date

Dec 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2014

Last Update Posted Date

Aug 22, 2014Estimated

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Idebenone	Experimental		Drug: Idebenone
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Idebenone	Drug		Idebenone
Placebo

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029242	Optic Atrophy, Hereditary, Leber

Ancestor Terms

ID	Term
D015418	Optic Atrophies, Hereditary
D009896	Optic Atrophy
D009901	Optic Nerve Diseases
D003389	Cranial Nerve Diseases

Browse Leaves

Not provided

Browse Branches

Not provided