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ROCK Inhibitor
Fasudil for Tauopathies (ROCKIT-1 Trial)
Phase 2
Waitlist Available
Led By Peter Ljubenkov, MD
Research Sponsored by Woolsey Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
ROCKIT-1 Trial Summary
This trial is testing if a drug called fasudil is safe and tolerated in patients with tauopathies, which are progressive neurological diseases. The trial will also test if fasudil has any effect on biomarkers associated with the disease.
Eligible Conditions
- Progressive Supranuclear Palsy
- Cortical Basal Ganglionic Degeneration
ROCKIT-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events
Secondary outcome measures
Biomarkers of neurodegeneration
Imaging biomarkers of neurodegeneration
Phosphorylated tau
ROCKIT-1 Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Oral fasudil 180 mg/day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fasudil
2007
Completed Phase 3
~140
Find a Location
Who is running the clinical trial?
Woolsey PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
54 Total Patients Enrolled
Peter Ljubenkov, MDPrincipal InvestigatorUCSF Weill Institute for Neurosciences
3 Previous Clinical Trials
214 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have thoughts of hurting yourself that could cause safety concerns or affect the study results.You have taken another experimental drug within the last 30 days or 5 half-lives of the drug, whichever is longer. You are not allowed to take any other experimental drugs while participating in this study, except for fasudil.You cannot have a lumbar puncture at screening if you are taking certain blood-thinning medications like warfarin. However, taking a stable dose of low-dose aspirin is allowed.You have taken strong steroids within the last month or the time it takes for the medication to leave your body.You are taking more than one of the following types of medications: long-acting nitrates, beta-blockers, or calcium channel blockers.You are allergic to the inactive ingredients in the study drug, fasudil.You have had a type of cancer other than basal cell carcinoma in the past 5 years.Your progranulin levels have been consistently lower than the normal range in past blood tests.Your memory and thinking test score at the screening is between 20 and 30.Your brain scan or other tests show that you don't have signs of Alzheimer's disease.You currently have a serious viral infection.You have symptoms that likely indicate Alzheimer's disease, as defined by the National Institute on Aging and the Alzheimer's Association.You don't have any other medical conditions that could cause problems with memory or movement, like seizures, stroke, or substance abuse.You have shown a good and lasting response to levodopa treatment, according to the study doctor.You have serious heart, blood, kidney, or liver problems.Your blood tests show low levels of white blood cells or platelets, or high levels of certain liver enzymes or bilirubin.Your blood test shows that your creatinine level is higher than 1.3 mg/dL.You can walk at least 10 steps with a little help, like using one arm for support or using a cane or walker.Your Mini-Mental State Exam (MMSE) score at the screening is between 20 and 30.You have a history of specific gene mutations related to a certain type of brain disease.Your blood pressure is lower than 90 over 60.You have signs of low blood pressure when standing up.You are between 35 and 80 years old.You can walk at least 10 steps with a little help, like holding onto someone's arm or using a cane or walker.Your brain scan does not show signs of Alzheimer's disease, or you have had a negative result on a previous brain scan or spinal fluid test for Alzheimer's disease.The MRI results show signs of a specific brain disease, and there are no major strokes or severe white matter disease.Only applies to CBS. You have symptoms that suggest you may have corticobasal degeneration (CBD), CBS subtype according to the 2013 consensus criteria.You meet the specific medical criteria for possible or probable progressive supranuclear palsy-Richardson syndrome (PSP-RS).You are between 35 and 80 years old.You can continue taking your regular prescription medications as long as the dosage has not changed for the 30 days before the start of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
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.
Progressive Supranuclear Palsy Patient Testimony for trial: Trial Name: NCT04734379 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still an opportunity for prospective participants to join this experiment?
"As detailed on clinicaltrials.gov, this trial is not in the midst of patient recruitment at present. It was originally posted on January 22nd 2021 and last updated on May 31st 2022, however 1410 other trials are currently looking for enrollees."
Answered by AI
For whom is eligibility for this study available?
"Individuals with supranuclear palsy that is in a state of progression, between the ages of 35 and 80, can be considered for enrollment. This trial will accept about 15 persons total."
Answered by AI
Has the US Food and Drug Administration cleared Fasudil for patient use?
"Assessing the safety of Fasudil, our team at Power judged it to be a 2. This is because while there has been some evidence on its security profile, no studies have yet established efficacy."
Answered by AI
Does this research endeavor accept adults above the age of twenty?
"Based on the prerequisites for participation, interested patients must be between 35 and 80 years old."
Answered by AI
How many individuals have been enrolled in this trial thus far?
"This research has concluded its participant recruitment, having been first posted on January 22nd 2021 and last updated on May 31st 2022. For those seeking alternative trials, there are 1407 studies actively recruiting supranuclear palsy patients and 3 using Fasudil as the intervention."
Answered by AI
Who else is applying?
What state do they live in?
California
New York
What site did they apply to?
University of California Weill Institute for Neurosciences
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
I am fine with visits, as my husband will take me and is happy reading the news on his iphone or a book while he waits. I think I would be most interested in understanding why this drug is being tested. There must be some clinical reason for suspecting it has beneficial qualities. If so, is the hope that the drug will control symptoms or arrest progress of the disease? Also, if the trial is successful after 48 weeks, may I be included in subsequent trials of the drug?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
Clinical intervention type trial.
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- University of California Weill Institute for Neurosciences: < 48 hours
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