Biomarkers in Different Types of Amyotrophic Lateral Sclerosis (ALS) Patients Being Treated With Edaravone

Part of paid clinical trials in Loma Linda, California.

Sponsor
Loma Linda University
Study ID
NCT04097158
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Sample Collection — OTHER
    The investigators will be collecting blood, urine, and spinal fluid samples.

Study Details

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.

Key Dates

Start date
Oct 8, 2019
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
160 participants (estimated)

Arms

  • Arm: Upper Motor Neuron predominant ALS
  • Arm: Lower Motor Neuron predominant ALS
  • Arm: Bulbar predominant ALS
  • Arm: Generalized ALS

Primary Outcome Measure

Define pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in different ALS/MND phenotypes. [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Loma Linda UniversityLoma LindaCalifornia92354
Imran Qasim
[email protected]
909-558-2037
Jeffrey Rosenfeld, MD (PRINCIPAL_INVESTIGATOR)

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