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Rho Kinase Inhibitor
Rho Kinase Inhibitor for ALS (REAL Trial)
Phase 2
Waitlist Available
Research Sponsored by Woolsey Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of probable laboratory-supported, probable, or definite ALS by Screening 1, with no other cause of neurological impairment identified by Screening 2
WCBP must agree to abstain from sex or use contraception, and males must agree to abstain from sex with WCBP or use contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly from screening to week 12; every six weeks to week 24
Awards & highlights
REAL Trial Summary
This trial is testing a new drug for ALS patients to see if it is safe and effective.
Who is the study for?
This trial is for adults aged 18-75 with ALS diagnosed within the last 4 years, showing a specific rate of disease progression. Participants must have been on stable doses of certain ALS medications if they're taking them and agree to use contraception. Those with severe blood pressure issues, kidney problems, other neuromuscular diseases, or who are pregnant can't join.Check my eligibility
What is being tested?
The REAL trial is testing Fasudil (WP-0512), a Rho Kinase Inhibitor, in an open-label Phase 2a study to evaluate its safety and effectiveness in slowing down the progression of ALS. It also looks at how the drug affects certain biomarkers related to the disease.See study design
What are the potential side effects?
While specific side effects for WP-0512 aren't listed here, similar drugs often cause headaches, dizziness, nausea, low blood pressure or changes in heart rate. Side effects may vary based on individual health conditions.
REAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with ALS and no other cause for my symptoms has been found.
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I agree to use contraception or abstain from sex.
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My ALS symptoms started less than 4 years ago.
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I am between 18 and 75 years old.
REAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ monthly from screening to week 12; every six weeks toweek 24]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly from screening to week 12; every six weeks toweek 24]
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
Change in the slope of the decline Revised ALS Functional Rating Scale (ALSFRS-R) during treatment vs pre-treatment
Change in the slope of the decline in muscle strength during treatment vs pre-treatment
Change in the slope of the decline in percent predicted Slow Vital Capacity (SVC) during treatment vs pre-treatment
REAL Trial Design
1Treatment groups
Experimental Treatment
Group I: FasudilExperimental Treatment1 Intervention
Oral fasudil up to 240 mg/day
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Who is running the clinical trial?
Woolsey PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
39 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Fasudil
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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