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Rho Kinase Inhibitor for ALS (REAL Trial)
REAL Trial Summary
This trial is testing a new drug for ALS patients to see if it is safe and effective.
REAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowREAL Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.REAL Trial Design
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Who is running the clinical trial?
Media Library
- I have been on a stable dose of my ALS medication for the required time.Your ALS disease is getting worse at a steady rate of 0.5 to 3 points per month.I have been diagnosed with ALS and no other cause for my symptoms has been found.My blood tests show low neutrophils or platelets, high INR, or I can't have a spinal tap.I am on a breathing machine through a hole in my neck.I agree to use contraception or abstain from sex.I expect my ALS medication doses to change during the study.Your liver enzymes (ALT or AST) are more than three times the normal limit at the second screening.Your lung function is at least 50% of what is expected for someone your age and size.My ALS symptoms started less than 4 years ago.Your blood pressure is too low at the time of screening.Your kidney function is not strong enough, with an eGFR of less than 45 mL/min/1.73m2 at a specific screening.You have thoughts of harming yourself that could be dangerous.You are allergic to any of the ingredients in the study drug.I am between 18 and 75 years old.Your ALS Functional Rating Scale score is less than 24 at the first screening.I have a condition that causes muscle weakness or a neurodegenerative disease.I have not taken clenbuterol in the last 28 days or between my first screening and enrollment.I am taking more than one type of heart medication.You have received experimental gene therapies for ALS.I stopped taking my previous medications at least 28 days before my first screening.
- Group 1: Fasudil
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any available slots open to prospective participants in this experiment?
"Information on clinicaltrials.gov confirms that this medical study, which was initially put up for public viewing on December 22nd 2021, is actively recruiting participants. The trial's latest update took place October 28th 2022."
Is participation restricted to those over a certain age, such as 75 years of age?
"This clinical trial is only available to those between the ages of 18 and 75. Patients under 18 years old can find 44 studies, while those over 65 have access to 394 trials."
How many participants is the research team aiming to recruit?
"Affirmative. Clinical trials registry data demonstrates that this research study is currently looking for participants to join its ranks. This trial was posted on December 22nd 2021 and updated October 28th 2022, with a need of 20 patients across 8 different sites."
Do I have the necessary qualifications to be part of this research study?
"This medical trial is seeking roughly 20 participants who are suffering from amyotrophic lateral sclerosis and within the ages of 18 to 75."
Has the FDA sanctioned Fasudil (WP-0512) for public use?
"Our team at Power has assessed the safety of Fasudil (WP-0512) to be a 2, given that it is currently in Phase 2 and there are established data confirming its security but no evidence yet for efficacy."
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