A Study to Evaluate the Performance of a Diagnostic Test in ALS

Status unconfirmed

Conditions studied: Amyotrophic Lateral Sclerosis (ALS)

In brief

Prospective multicenter study of subjects who were recently diagnosed with amyotrophic lateral sclerosis (ALS) or another neurodegenerative disease (including spinal cord diseases, muscle diseases and neurological diseases such as multiple sclerosis, multifocal motor neuropathy, myasthenia gravis and spinal muscular atrophy) or who are currently undergoing diagnostic procedures for the aforementioned diseases. Approximately 300 subjects will be enrolled. Subjects will undergo a lumbar puncture (LP) for cerebro-spinal fluid (CSF) collection; blood collection for serum, plasma, RNA, and DNA (optional); urine collection (optional); and skin biopsy (optional) in a single visit. No study treatment will be administered. Subjects will be managed and treated by their respective physicians; choice of therapy or laboratory tests will not be impacted by the study. Clinical diagnosis may be confirmed by the subject's physician and communicated to the study's Principal Investigator (PI) by scheduled telephone calls.

Key facts

Study ID

NCT02759913

Run by

Iron Horse Diagnostics, Inc.

People needed

300

Starts

2015-01-01

Expected to finish

2016-12-01

Last updated by the study team

2016-05-03

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be eligible to participate in this study, candidates must meet the following eligibility criteria at the Screening Visit:
• Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
• Aged 21 to 80 years old, inclusive.
• Must meet one of the following:
• Recent diagnosis of sporadic or familial ALS (within 18 months of first visit for ALS symptoms) according to the World Federation of Neurology El Escorial criteria (revised according to the Airlie House Conference 1998 [Brooks 1999] ).
• Recent diagnosis of neuromuscular disease other than ALS (within 12 months of first visit for neurologic symptoms).
• Undergoing diagnostic procedures for neuromuscular disease.
• Willingness and medical ability to comply with scheduled visits, LP for CSF collection, laboratory tests, and other study procedures.

You may not qualify if…

• Candidates will be excluded from study entry if any of the following exclusion criteria exist at the Screening Visit:
• Any contraindications to having an LP, including but not limited to:
• Platelet count <100,000/µL.
• History of bleeding disorder.
• Use of platelet antiaggregant or anticoagulant drugs, including but not limited to clopidogrel, dipyridamole, ticlopidine , and warfarin. Use of aspirin at a prophylactic dose of 75-325 mg r less is acceptable.
• History of intolerance to the LP procedure.
• Evidence of topical or other skin infection at the LP site.
• Prior spinal fusion surgery or other spinal surgery at the LP site.
• If undergoing skin biopsy, evidence of topical or other skin infection at the biopsy site.
• History of allergy or other adverse reaction to local anesthetics used in the study.
• History of traumatic central nervous system injury or stroke.
• History of chronic liver or renal failure.
• Requirement for artificial respiration, including tracheostomy and any use of bilevel positive airway pressure (BiPAP) therapy.
• Female subjects who are pregnant or currently breastfeeding.
• Current enrollment in any other investigational drug, medical devices, or disease study.
• Other unspecified reasons that, in the opinion of the Investigator or Iron Horse, make the subject unsuitable for enrollment.

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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