Leber Hereditary Optic Neuropathy (LHON) Historical Case... | NCT01892943

Studies
Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey

NCT01892943

Sponsor

Santhera Pharmaceuticals

Status

Completed

Last Update Posted

May 15, 2014Estimated

Enrollment

306Actual

Phase

Not provided

Conditions

Leber Hereditary Optic Neuropathy (LHON)

Interventions

Not provided

Countries

Belgium
Denmark
France
Italy
Slovenia

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

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Jun 26, 2013

First Submission Date that Met QC Criteria

Jul 1, 2013

First Posted Date

Jul 8, 2013Estimated

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

May 14, 2014

Last Update Posted Date

May 15, 2014Estimated

Name	Class
European Vision Institute Clinical Research Network	NETWORK

Description Module

Brief Summary

The objective of this survey is to establish the clinical course of vision loss and recovery in patients with a genetically confirmed diagnosis of Leber Hereditary Optic Neuropathy (LHON).

Visual acuity changes over time from onset of symptoms and from visual acuity nadir will be the main endpoint analysed.

The survey will collect historically documented visual acuity data for all patients at participating sites with a genetically confirmed diagnosis of LHON. No exclusion criteria apply. Patients are not required to attend the clinic for the survey.

Data will be collected in a completely anonymous manner. Ethical approvals and data release agreements will be obtained as required by local regulations.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

306Actual

Label	Type	Description	Intervention Names
Patients with LHON

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity	The Entire duration of the disease patient by patient basis up to the date of completion of the Case Report Form (CRF).	average 0 to 10 years (retrospective)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with genetically confirmed diagnosis of LHON

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with genetically confirmed diagnosis of LHON

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose-Alain Sahel, MD	Centre de Recherche Institut de la Vision INSERMN	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Leuven		Leuven		3000	Belgium
Glostrup Hospital/National Eye Clinic of the Kennedy Center/University of Copenhagen Department of Ophthalmology

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