Trial · NCT05218668
Rho Kinase Inhibitor in Amyotrophic Lateral Sclerosis (REAL)
NCT05218668, Phase 2, Active not recruiting, Woolsey Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rho Kinase Inhibitor in Amyotrophic Lateral Sclerosis (REAL). Trials, record NCT05218668. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05218668
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rho Kinase Inhibitor in Amyotrophic Lateral Sclerosis (REAL)
- NCT number
- NCT05218668
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Woolsey Pharmaceuticals
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Fasudil (WP-0512), Fasudil (WP-0512)
- First posted
- 2022-02-01
- Last updated
- 2025-04-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Through study completion, up to 216 weeks | Incidence of Adverse Events (AEs\] and Serious Adverse Events (SAEs) as assessed by clinically significant abnormal physical examination findings; changes in vital signs; 12-lead electrocardiogram (ECG); magnetic resonance imaging (MRI); and hematology, blood chemistry, liver function, and urine tests. |
| Secondary | Change in the slope of the decline Revised ALS Functional Rating Scale (ALSFRS-R) during treatment vs pre-treatment lead-in | Monthly from Screening to Week 12; Every six weeks to Week 24; Every 12 weeks to Week 206 | The ALSFRS-R is a validated rating instrument for monitoring the progression of disability inpatients with ALS and is utilized for monitoring functional change in ALS patients. The score assesses various 4 domains including: (i) bulbar function (speech, salivation, swallowing); (ii)fine motor task (handwriting, cutting food and handling utensils, with or without gastrostomy, dressing and hygiene); (iii) gross motor task (turning in bed, walking, climbing stairs); and (iv)respiratory function (dyspnea, orthopnea and respiratory insufficiency). |
| Secondary | Change in the slope of the decline in percent predicted Slow Vital Capacity (SVC) during treatment vs pre-treatment lead-in | Monthly from Screening to Week 12; Every six weeks to Week 24; Every 12 weeks to Week 206 | The SVC will be measured using the study-approved portable spirometer, and assessments will be performed using a face mask. Three SVC trials are required for each testing session, however up to 5 trials may be performed if the variability between the highest and second highest SVC is 10% or greater for the first 3 trials. The highest SVC recorded is utilized for eligibility. At least 3 measurable SVC trials must be completed to score SVC for all visits after screening. Predicted SVC values and percent predicted SVC values will be calculated using the Quanjer Global Lung Initiative equations. |
| Secondary | Change in the slope of the decline in muscle strength during treatment vs pre-treatment lead in | Monthly from Screening to Week 12; Every six weeks to Week 24; Every 12 weeks to Week 206 | A spring-loaded device that "breaks" at pre-set forces will be used to assess readings obtained by HHD throughout the study. Grip strength dynamometry for both hands will be acquired, and the mean force in kilograms will be calculated. Measures will be obtained from each hand in triplicate. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05218668
GET https://conductscience.org/api/trials/v1/NCT05218668/registered