The Pre-Familial Amyotrophic Lateral Sclerosis (Pre-fALS) Study - Tabular View

Tracking Information

First Received Date ^ICMJE

April 24, 2006

Last Updated Date

February 16, 2009

Start Date ^ICMJE

April 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Risk Factors for Progression to familial ALS [ Time Frame: Years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00317616 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

The Pre-Familial Amyotrophic Lateral Sclerosis (Pre-fALS) Study

Official Title ^ICMJE

The Pre-Familial Amyotrophic Lateral Sclerosis (Pre-fALS) Study

Brief Summary

We aim to recruit unaffected (healthy) people from SOD1 positive families in which at least two relatives have been affected with ALS. Our goal is to identify factors, both genetic and environmental, which put people at risk for developing ALS in the future.

Detailed Description

Healthy people from SOD1 positive familial ALS families will be included in this study. We encourage people who know that they are SOD1 positive as well as those who do not know their SOD1 status to contact us. Those who wish to participate and to learn the results of genetic testing, may do so after undergoing genetic counseling. It is also possible to participate without learning the results of genetic testing. Participants in the study will travel to Emory (at our expense) on an annual basis.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Amyotrophic Lateral Sclerosis

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

A member of a family in which at least two relatives have been or currently are affected with ALS.
The presence of a genetic change (mutation) in the SOD1 gene in a family member.
No symptoms to suggest the presence of ALS (i.e. study participants must currently be healthy).
Willingness to undergo genetic testing, with the option of whether or not to learn the results.
Willingness to travel to Emory annually for in-person study evaluations.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sue Gronka, RN

888-413-9315

fALS@emory.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00317616

Responsible Party

Michael Benatar, Emory University

Study ID Numbers ^ICMJE

1369-2005

Study Sponsor ^ICMJE

Emory University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Michael Benatar, MD, PhD.

Emory University

Information Provided By

Emory University

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP