DISEASE CLASSIFICATION(S):
Amyotrophic Lateral Sclerosis(ALS)
NAME OF CLINICAL TRIAL/STUDY:
Genetic and Environmental Epidemiology Study
TRIAL UPDATES:
July 2010
This study has now been expanded into a multicenter study. See Study to Probe Oxidatives Stress in People With ALS and Oxidative Stress in ALS-Multicenter Study.
January 2009
All ALS-affectd participants have been enrolled. The study is still enrolling healthy participants (control group).
June 2008
85 percent of participants have been enrolled.
March 2007
Over 50 percent of participants have been enrolled.
November 2005
The study is now in phase 2.
PURPOSE AND RATIONALE:
The study seeks to determine what, if any, relationship exists between genetic makeup, environmental exposures and the development of ALS. This study is not a clinical trial.
STUDY DETAILS:
This is a study of ALS patients and healthy people with whom they will be compared ("controls") recruited from the patient's family. The study is enrolling 100 patients with one to three controls each.
Patients and controls undergo an extensive telephone or in-person interview regarding family structure and medical history, residential history, physical activities, hobbies and leisure activities, occupational history, alcohol and tobacco use and military service. The questionnaire has already been tested for reliability between telephone or in-person interview history.
Each participant has a one-time blood collection for DNA analysis.
OPENING DATES:
Sept. 1, 2004
CLOSING DATES:
Uncertain
TARGET NUMBER OF PARTICIPANTS:
300
RECRUITMENT STATUS:
Closed
ELIGIBILITY REQUIREMENTS:
All participants must
- be at least 18 years old
- be fluent in English
- be able to tolerate speaking for a 1.5 to two-hour interview
Participants with ALS must
- have had symptom onset within 18 months of study enrollment
Participants without ALS (controls) must
- be a blood-relative sibling of a participating ALS patient or, if a non-blood relative is enrolled (see below), a sibling of a non-blood relative subject
- be a non-blood relative, preferably of the same gender and within five years of age of the participating ALS patient