Status:
COMPLETED
Validation of Biomarkers in Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
ALS Association
ALS Therapy Alliance
Conditions:
Amyotrophic Lateral Sclerosis
Lou Gehrig's Disease
Eligibility:
All Genders
30-80 years
Brief Summary
The purpose of this study is to collect 650 blood and 300 cerebrospinal fluid (CSF) samples from people with amyotrophic lateral sclerosis (ALS), pure lower or upper motor neuron diseases, as well as ...
Detailed Description
Researchers tested what changes happen in volunteers with ALS that can be seen in the blood and what changes are unique to ALS and are different from those found in healthy volunteers and volunteers w...
Eligibility Criteria
Inclusion
- ALS Volunteers
- Diagnosis of possible (excluding volunteers with UMN signs ONLY), probable, probable-laboratory supported, or definite ALS, either sporadic or familial according to revised El Escorial criteria
- Disease duration of less than or equal to two years from symptom onset
- Age 30-80 years at the time of disease onset
- Ability to provide informed consent
- Ability to comply with study procedures
- Medically safe to have lumbar puncture (lumbar puncture volunteers only)
Exclusion
- Clinical evidence of chronic liver or renal failure
- Presence of a bleeding disorder, problems with CSF pressure, allergy to local anesthetics, or a topical or other skin infection at the LP site (lumbar puncture volunteers only)
- Use of any anti-platelet or anticoagulant drugs, such as plavix, aggrenox, ticlid, warfarin or coumadin (lumbar puncture volunteers only)
- Suspected ALS (PMND) Volunteers
- Inclusion Criteria:
- Diagnosis of suspected ALS defined as presence of UMN or LMN signs alone and the diagnosis of Clinically Probably Laboratory-Supported ALS CANNOT be proven by evidence in clinical grounds in conjunction with electrodiagnostic, neurophysiologic, neuroimaging or clinically laboratory studies
- Disease duration of less than or equal to four years from symptom onset
- Age 30-80 years at time of disease onset
- Ability to provide informed consent
- Ability to comply with study procedures
- Medically safe to have lumbar puncture (lumbar puncture volunteers only)
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
475 Patients enrolled
Trial Details
Trial ID
NCT00677768
Start Date
April 1 2008
End Date
November 1 2015
Last Update
June 3 2016
Active Locations (30)
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1
Phoenix Neurological Associates, Ltd.
Phoenix, Arizona, United States, 85018
2
University of California Irvine
Orange, California, United States, 92868
3
Mayo Clinic Neurology
Jacksonville, Florida, United States, 32224
4
University of Miami
Miami, Florida, United States, 33136