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Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01892943
Recruitment Status : Completed
First Posted : July 8, 2013
Last Update Posted : May 15, 2014
Sponsor:
Collaborator:
European Vision Institute Clinical Research Network
Information provided by (Responsible Party):
Santhera Pharmaceuticals

Tracking Information
First Submitted Date June 26, 2013
First Posted Date July 8, 2013
Last Update Posted Date May 15, 2014
Study Start Date August 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2013)
Visual acuity [ Time Frame: average 0 to 10 years (retrospective) ]
The Entire duration of the disease patient by patient basis up to the date of completion of the Case Report Form (CRF).
Original Primary Outcome Measures
 (submitted: July 1, 2013)
Visual acuity [ Time Frame: average 0 to 10 years (retrospective) ]
The Entire duration of the disease patient by patient basis up to the date of completion of the CRF.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey
Official Title Not Provided
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with genetically confirmed diagnosis of LHON
Condition Leber Hereditary Optic Neuropathy (LHON)
Intervention Not Provided
Study Groups/Cohorts Patients with LHON
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 14, 2014)
306
Original Enrollment Not Provided
Actual Study Completion Date February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients with genetically confirmed diagnosis of LHON
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   Denmark,   France,   Italy,   Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01892943
Other Study ID Numbers LHON HCR
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Santhera Pharmaceuticals
Study Sponsor Santhera Pharmaceuticals
Collaborators European Vision Institute Clinical Research Network
Investigators
Principal Investigator: Jose-Alain Sahel, MD Centre de Recherche Institut de la Vision INSERMN
PRS Account Santhera Pharmaceuticals
Verification Date May 2014