Recruiting

Diagnostic Test

Sponsor:

Iron Horse Diagnostics, Inc.

Code:

NCT02759913

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Lumbar puncture

Study Details

Brief summary:

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.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Study ID

NCT02759913

Start date

Jan, 2015

Status verified date

Apr, 2016

Completion date

Dec, 2016

Anticipated

Primary completion date

Aug, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • To be eligible to participate in this study, candidates must meet the following eligibility criteria at the Screening Visit:

1. 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.
2. Aged 21 to 80 years old, inclusive.
3. 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.
4. Willingness and medical ability to comply with scheduled visits, LP for CSF collection, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Candidates will be excluded from study entry if any of the following exclusion criteria exist at the Screening Visit:

1. 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.
2. If undergoing skin biopsy, evidence of topical or other skin infection at the biopsy site.
3. History of allergy or other adverse reaction to local anesthetics used in the study.
4. History of traumatic central nervous system injury or stroke.
5. History of chronic liver or renal failure.
6. Requirement for artificial respiration, including tracheostomy and any use of bilevel positive airway pressure (BiPAP) therapy.
7. Female subjects who are pregnant or currently breastfeeding.
8. Current enrollment in any other investigational drug, medical devices, or disease study.
9. Other unspecified reasons that, in the opinion of the Investigator or Iron Horse, make the subject unsuitable for enrollment.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Amyotrophic lateral sclerosis

Participants recently diagnosed with ALS in a neuromuscular clinic, using the ALS functional rating scale (ALSFRS-R). Lumbar puncture (LP) for cerebro-spinal fluid (CSF) collection The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.

ALS mimics

Other motorneuron disorders, isolated upper and lower motoneuron disorders Lumbar puncture (LP) for cerebro-spinal fluid (CSF) collection

Interventions

Lumbar puncture

Collection of biofluids to determine the accuracy, sensitivity and specificity of a diagnostic test developed by Iron Horse Diagnostics

Primary outcome measure

  • Biomarker Measurement of phosphorylated neurofilament heavy chain (pNfH) and complement C3 in CSF [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Andreas Jeromin, PhD

3526727358andreasjeromin@ironhorsedx.com

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Irys Caristo

261-444-0173caristi@ccf.org

More Information

Sponsor

Iron Horse Diagnostics, Inc.

Last update posted

May 3, 2016

Last verified

Apr, 2016

Keywords

  • neuromuscular diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-12. This information was provided to ClinicalTrials.gov by Iron Horse Diagnostics, Inc. on 2016-05-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.