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| Name | Class |
|---|---|
| Temple University | OTHER |
| Thomas Jefferson University | OTHER |
| University of Southern California | OTHER |
| Northwestern University |
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This study is being conducted to help the investigators better understand how the new FDA approved medication Edaravone (also known as Radicava) works in subsets of patients with ALS. The investigators are also trying to understand if there are specific ALS patients, with different presentations of ALS, who might benefit most from this medication. Also, the investigators are following specific biomarkers to determine the optimal treatment duration in patients with different forms of ALS
There is no study medication being offered in this trial. Edaravone is prescribed as part of regular care. In this trial we are collecting blood, urine, and spinal fluid samples in ALS patients who are taking Edaravone and ALS patients who are not taking Edaravone to measure certain markers that could indicate why the drug may be working in a specific type of ALS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upper Motor Neuron predominant ALS |
| ||
| Lower Motor Neuron predominant ALS |
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| Bulbar predominant ALS |
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| Generalized ALS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sample Collection | Other | The investigators will be collecting blood, urine, and spinal fluid samples. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Define pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in different ALS/MND phenotypes. | The investigators aim to identify 4 cohorts of patients with distinct ALS/MND phenotypes and measure a panel of pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in the CSF, blood, and urine. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Anyone who meets the Inclusion/Exclusion Criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Imran Qasim | Contact | (909) 558-2037 | 25388 | sqasim@llu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Rosenfeld, PhD, MD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Recruiting | Loma Linda | California | 92354 | United States |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| OTHER |
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Blood Spinal Fluid Urine
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |