Amyotrophic Lateral SclerosisPhase 2REALNCT05218668
Rho Kinase Inhibitor in Amyotrophic Lateral Sclerosis (REAL)
A Phase 2 study testing Fasudil (WP-0512) in people with Amyotrophic Lateral Sclerosis, run by Woolsey Pharmaceuticals at 12 sites in 2 countries.
Trial summary
A Phase 2a Open-Label Preliminary Safety, Efficacy, and Biomarker Study of WP-0512 in Patients with Amyotrophic Lateral Sclerosis (ALS) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Fasudil (WP-0512)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 22 Dec 2021to Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 75 years of age (inclusive) at Screening 1.
- Subject has had a diagnosis of probable laboratory-supported, probable, or definite ALS (as defined by El Escorial Revised ALS diagnostic criteria) by Screening 1, and no other cause of the neurological impairment has been identified.
- Average decrease in ALSFRS-R of 0.5 to 3 (inclusive) points per month, calculated using: Cohort 1 - the most recent historical ALSFRS-R score from at least 3 months prior to Screening 1. If there is no qualifying previous score, an estimated rate will be calculated using the historical date of ALS symptom onset (weakness and/or dysarthria and/or dysphagia). Cohort 2 - the historical date of ALS symptoms onset.
- Percent predicted SVC ≥ 50% at Screening 1.
- ALS symptom onset (weakness and/or dysarthria, and/or dysphagia) within 48 months of Screening 1.
- Subjects taking riluzole, edaravone, or phenylbutyrate (PB) and/or tauroursodeoxycholic acid (TUDCA) may be included if the following criteria are met at Screening 1, and there is no change in treatment between Screening 1 and Enrollment:
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- Stable dose of riluzole for at least 30 days;
- Stable dose of edaravone for at least 3 cycles; and/or
- Stable dose of PB and/or TUDCA for at least 90 days
- Subjects taking any of these drugs prior to screening who intend to discontinue them before starting the study must have discontinued the drug(s) at least 28 days before Screening 1.
- Women of childbearing potential (WCBP) must agree to abstain from sex or use an adequate method of contraception for the duration of the screening period, the study drug treatment period, and for 28 days after the last dose of study drug.
- Males must agree to abstain from sex with WCBP or use an adequate method of contraception for the duration of the study drug treatment period and for 75 days after.
- Capable of providing informed consent and following trial procedures (where subject consents but is unable to sign the informed consent a legally authorized representative (LAR)/surrogate must sign on their behalf).
Who cannot join
- ALSFRS-R < 24 at Screening 1.
- Expected change in dosing of riluzole, edaravone, or PB and/or TUDCA between Screening 1 and the end of the study.
- Presence of other causes of neuromuscular weakness or other neurodegenerative diseases that could interfere with the objectives of the study or the safety of the subject, in the opinion of the Investigator.
- Mechanical ventilation via tracheostomy. (Use of non-invasive ventilation e.g., continuous positive airway pressure, non-invasive bi-level positive airway pressure or non-invasive volume ventilation is not an exclusion).
- Any medical condition (including cardiovascular, hematologic, renal, hepatic, or psychiatric diseases) that in the opinion of the Investigator would disallow safe participation in the trial or interpretation of the study results.
- Suicidal ideation per the Columbia-Suicide Severity Rating Scale (C-SSRS) that in the opinion of the Investigator would pose a safety risk.
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- ALT ≥ 3 x upper limit of normal (ULN) or aspartate aminotransferase (AST) ≥ 3 x ULN at Screening.
- Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2 at Screening.
- Participants who, in the opinion of the Investigator, are unable or unlikely to comply with the dosing schedule or study evaluations.
- Treatment in a clinical trial with another investigational drug within 28 days or 5 half-lives of drug before Screening 1, whichever is longer.
- Exposure at any time to any gene therapies under investigation for the treatment of ALS.
- Treatment with clenbuterol within 28 days of Screening 1, or any time between Screening 1 and enrollment.
- On more than one of the following drug classes: long-acting nitrates, beta-blockers, or calcium channel blockers. (Note: subjects may be on one of the drug classes.)
- Systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 60 mmHg at Screening. (Note: in the case of a systolic blood pressure < 90 and/or diastolic blood pressure < 60, BP measurements should be repeated after 10 minutes, and the higher reading used for Inclusion/Exclusion.)
- Known hypersensitivity to the active (fasudil) or inactive ingredients in the study drug.
- Known to be pregnant or lactating; or positive pregnancy test for WCBP.
- For Cohort 1 only: At Screening 2, neutrophil count < 1,500/mm3, platelets < 100,000/mm3, international normalized ratio (INR) > 1.5 or any contraindication to or unable to tolerate lumbar puncture, including use of anticoagulant medications that cannot be withheld. For example, if a subject is taking warfarin and it cannot be withheld for lumbar puncture, this would exclude the subject from study entry.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States9 sites
University of Colorado
Aurora, Colorado, 80045
Northwestern University
Chicago, Illinois, 60611
National Jewish Health
Denver, Colorado, 80206
University of Kentucky
Lexington, Kentucky, 40506
Lakes Research
Miami Lakes, Florida, 33014
Hospital for Special Surgery
New York, New York, 10021
Neuromuscular Research Center
Phoenix, Arizona, 85028
Cox Medical Center
Springfield, Missouri, 65807
University of South Florida
Tampa, Florida, 33620
Australia3 sites
Royal Brisbane and Women's Hospital
Brisbane, Queensland, QLD 4029
Calvary Health Bethlehem Hospital
Melbourne, Victoria, VIC 3195
Macquarie University Hospital
Sydney, New South Wales, NSW 2109
About this study
Official title: A Phase 2a Open-Label Preliminary Safety, Efficacy, and Biomarker Study of WP-0512 in Patients With Amyotrophic Lateral Sclerosis (ALS)
A Phase 2a Open-Label Preliminary Safety, Efficacy, and Biomarker Study of WP-0512 in Patients with Amyotrophic Lateral Sclerosis (ALS)
Read the detailed description
The study population will consist of subjects with a diagnosis of probable laboratory-supported, probable, or definite ALS, as defined by El Escorial Revised ALS diagnostic criteria; with ALS symptom onset within 48 months; and with percent predicted SVC ≥ 50% at Screening 1. Subjects must also have an average rate of decline in ALSFRS-R at Screening 1 of 0.5 to 3.0 points/month, with rate of decline calculated using historical data (either prior ALSFRS-R score or date of ALS symptom onset).
This study will be composed of a Primary Phase, with 24 weeks of open-label treatment, and an optional 42-month Extension Phase. Two cohorts will be enrolled: subjects in Cohort 1 (the primary population) will be dosed at 180 mg/day, and those in Cohort 2 will be dosed at up to 300 mg/day.
Cohort 1:
After consent, participants will undergo two screening evaluations, which will occur over the course of the 8 weeks prior to dosing with study drug. At Screening 1/Visit 1 (8 weeks before start of dosing), ALS assessments of ALSFRS-R/SVC/muscle dynamometry (HHD and hand grip) will be performed, as will safety assessments. Subjects who meet the pertinent inclusion/exclusion criteria will return for a second screening visit (Screening 2/Visit 2) approximately 4 weeks later, and ALS and safety assessment will again be conducted. Subjects who meet the pertinent Screening 2 study entry criteria will be enrolled into the study.
On Visit 3/Day 1, evaluations will be performed and dosing with study drug will begin. Dosing will be initiated at 180 mg/day. Participants will have an in-person or telephone visit at Week 1 (Visit 4) to assess for safety and drug compliance. Additional visits will occur at Weeks 4 (Visit 5), 8 (Visit 6), 12 (Visit 7), 18 (Visit 8) and 24 (Visit 9), during which ALS assessments of ALSFRS-R/SVC/HHD will be performed. For subjects who do not enter the Extension Phase, a final post-treatment follow-up visit (Visit 10) will be conducted at Week 25 (or 7±2 days after early termination).
For subjects who consent to continue in the Extension Phase, visits will occur every three months, during which ALS assessments will be done.
Blood biomarker collection will occur between enrollment and commencement of treatment, and at Week 12 (Visit 7) and Week 24 (Visit 9); during the extension phase it will occur 3 months after Week 24. CSF biomarker collection will occur between enrollment and commencement of treatment, and at Week 24 (Visit 9).
Laboratory safety assessments and adverse events will be collected at each study visit.
Subjects/caregivers will be asked to maintain a log of adverse events, study drug compliance, and medication changes, which will be reviewed at each visit.
Cohort 2:
After Cohort 1 has completed at least 24 weeks of treatment, enrollment into Cohort 2 may begin. Study visits and treatment will be similar to those for Cohort 1, but with the following differences:
- Subjects in Cohort 2 will not participate in Screening 2 (V2). Rather, they will attend only one screening visit (Screening 1, V1), and rate of decline for study entry will be calculated based on the date of ALS symptom onset. Subjects who qualify at this visit will be enrolled into the study and return within 28 days to start treatment on Day 1. (Note: Because Cohort 2 subjects will not participate in the two-month pre-treatment lead-in period, they will not be included in analyses comparing changes in on-treatment vs pre-treatment lead-in slope of decline. However, results generated in this cohort will be compared to historical data.)
- Dosing will be initiated at 300 mg/day.
- Subjects must return to the clinic for Week 1 (V4) assessments
- Lumbar puncture/CSF collection and coagulation panel will not be performed. (Note: Because CSF will not be collected in Cohort 2, they will not be included in any analyses of CSF biomarkers or PK.)
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Fasudil (WP-0512)
- Keywords
- Fasudil
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasudil (WP-0512)Drug
Oral fasudil up to 180 mg/day
Fasudil (WP-0512)Drug
Oral fasudil up to 300 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Fasudil | Experimental | Oral fasudil at 180 mg/day Receives: Drug: Fasudil (WP-0512) |
| Cohort 2 - Fasudil | Experimental | Oral fasudil at 300 mg/day Receives: Drug: Fasudil (WP-0512) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Measured: Through study completion, up to 216 weeks
Secondary outcomes (3)
Change in the slope of the decline Revised ALS Functional Rating Scale (ALSFRS-R) during treatment vs pre-treatment lead-in
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).
Measured: Monthly from Screening to Week 12; Every six weeks to Week 24; Every 12 weeks to Week 206
Change in the slope of the decline in percent predicted Slow Vital Capacity (SVC) during treatment vs pre-treatment lead-in
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.
Measured: Monthly from Screening to Week 12; Every six weeks to Week 24; Every 12 weeks to Week 206
Change in the slope of the decline in muscle strength during treatment vs pre-treatment lead in
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.
Measured: Monthly from Screening to Week 12; Every six weeks to Week 24; Every 12 weeks to Week 206
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start22 Dec 2021
- Primary completionJul 2026 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open label, two arms
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woolsey Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218668
- Sponsor's protocol ID
- WP-0512-003
- Acronym
- REAL
- Status last verified
- Apr 2025
- First submitted
- 23 Nov 2021
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Open-Label Preliminary Safety, Efficacy, and Biomarker Study of WP-0512 in Patients With Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT05218668
- Acronym / sponsor ID
- REAL / WP-0512-003
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Fasudil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Woolsey PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2a Open-Label Preliminary Safety, Efficacy, and Biomarker Study of WP-0512 in Patients with Amyotrophic Lateral Sclerosis (ALS)
Detailed description
The study population will consist of subjects with a diagnosis of probable laboratory-supported, probable, or definite ALS, as defined by El Escorial Revised ALS diagnostic criteria; with ALS symptom onset within 48 months; and with percent predicted SVC ≥ 50% at Screening 1. Subjects must also have an average rate of decline in ALSFRS-R at Screening 1 of 0.5 to 3.0 points/month, with rate of decline calculated using historical data (either prior ALSFRS-R score or date of ALS symptom onset).
This study will be composed of a Primary Phase, with 24 weeks of open-label treatment, and an optional 42-month Extension Phase. Two cohorts will be enrolled: subjects in Cohort 1 (the primary population) will be dosed at 180 mg/day, and those in Cohort 2 will be dosed at up to 300 mg/day.
Cohort 1:
After consent, participants will undergo two screening evaluations, which will occur over the course of the 8 weeks prior to dosing with study drug. At Screening 1/Visit 1 (8 weeks before start of dosing), ALS assessments of ALSFRS-R/SVC/muscle dynamometry (HHD and hand grip) will be performed, as will safety assessments. Subjects who meet the pertinent inclusion/exclusion criteria will return for a second screening visit (Screening 2/Visit 2) approximately 4 weeks later, and ALS and safety assessment will again be conducted. Subjects who meet the pertinent Screening 2 study entry criteria will be enrolled into the study.
On Visit 3/Day 1, evaluations will be performed and dosing with study drug will begin. Dosing will be initiated at 180 mg/day. Participants will have an in-person or telephone visit at Week 1 (Visit 4) to assess for safety and drug compliance. Additional visits will occur at Weeks 4 (Visit 5), 8 (Visit 6), 12 (Visit 7), 18 (Visit 8) and 24 (Visit 9), during which ALS assessments of ALSFRS-R/SVC/HHD will be performed. For subjects who do not enter the Extension Phase, a final post-treatment follow-up visit (Visit 10) will be conducted at Week 25 (or 7±2 days after early termination).
For subjects who consent to continue in the Extension Phase, visits will occur every three months, during which ALS assessments will be done.
Blood biomarker collection will occur between enrollment and commencement of treatment, and at Week 12 (Visit 7) and Week 24 (Visit 9); during the extension phase it will occur 3 months after Week 24. CSF biomarker collection will occur between enrollment and commencement of treatment, and at Week 24 (Visit 9).
Laboratory safety assessments and adverse events will be collected at each study visit.
Subjects/caregivers will be asked to maintain a log of adverse events, study drug compliance, and medication changes, which will be reviewed at each visit.
Cohort 2:
After Cohort 1 has completed at least 24 weeks of treatment, enrollment into Cohort 2 may begin. Study visits and treatment will be similar to those for Cohort 1, but with the following differences:
- Subjects in Cohort 2 will not participate in Screening 2 (V2). Rather, they will attend only one screening visit (Screening 1, V1), and rate of decline for study entry will be calculated based on the date of ALS symptom onset. Subjects who qualify at this visit will be enrolled into the study and return within 28 days to start treatment on Day 1. (Note: Because Cohort 2 subjects will not participate in the two-month pre-treatment lead-in period, they will not be included in analyses comparing changes in on-treatment vs pre-treatment lead-in slope of decline. However, results generated in this cohort will be compared to historical data.)
- Dosing will be initiated at 300 mg/day.
- Subjects must return to the clinic for Week 1 (V4) assessments
- Lumbar puncture/CSF collection and coagulation panel will not be performed. (Note: Because CSF will not be collected in Cohort 2, they will not be included in any analyses of CSF biomarkers or PK.)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, two arms
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Fasudil | Experimental | Drug: Fasudil (WP-0512)Oral fasudil at 180 mg/day |
| Cohort 2 - Fasudil | Experimental | Drug: Fasudil (WP-0512)Oral fasudil at 300 mg/day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Between 18 and 75 years of age (inclusive) at Screening 1.
- Subject has had a diagnosis of probable laboratory-supported, probable, or definite ALS (as defined by El Escorial Revised ALS diagnostic criteria) by Screening 1, and no other cause of the neurological impairment has been identified.
- Average decrease in ALSFRS-R of 0.5 to 3 (inclusive) points per month, calculated using: Cohort 1 - the most recent historical ALSFRS-R score from at least 3 months prior to Screening 1. If there is no qualifying previous score, an estimated rate will be calculated using the historical date of ALS symptom onset (weakness and/or dysarthria and/or dysphagia). Cohort 2 - the historical date of ALS symptoms onset.
- Percent predicted SVC ≥ 50% at Screening 1.
- ALS symptom onset (weakness and/or dysarthria, and/or dysphagia) within 48 months of Screening 1.
Key exclusion criteria (17 listed)
- ALSFRS-R < 24 at Screening 1.
- Expected change in dosing of riluzole, edaravone, or PB and/or TUDCA between Screening 1 and the end of the study.
- Presence of other causes of neuromuscular weakness or other neurodegenerative diseases that could interfere with the objectives of the study or the safety of the subject, in the opinion of the Investigator.
- Mechanical ventilation via tracheostomy. (Use of non-invasive ventilation e.g., continuous positive airway pressure, non-invasive bi-level positive airway pressure or non-invasive volume ventilation is not an exclusion).
- Any medical condition (including cardiovascular, hematologic, renal, hepatic, or psychiatric diseases) that in the opinion of the Investigator would disallow safe participation in the trial or interpretation of the study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasudil (WP-0512)Oral fasudil up to 180 mg/day | Drug | Cohort 1 - Fasudil |
| Fasudil (WP-0512)Oral fasudil up to 300 mg/day | Drug | Cohort 2 - Fasudil |
Primary outcome
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 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.
3 secondary outcomes
Change in the slope of the decline Revised ALS Functional Rating Scale (ALSFRS-R) during treatment vs pre-treatment lead-in
Time frame: Monthly from Screening to Week 12; Every six weeks to Week 24; Every 12 weeks to Week 206
Change in the slope of the decline in percent predicted Slow Vital Capacity (SVC) during treatment vs pre-treatment lead-in
Time frame: Monthly from Screening to Week 12; Every six weeks to Week 24; Every 12 weeks to Week 206
Change in the slope of the decline in muscle strength during treatment vs pre-treatment lead in
Time frame: Monthly from Screening to Week 12; Every six weeks to Week 24; Every 12 weeks to Week 206
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fasudil (WP-0512) in people with Amyotrophic Lateral Sclerosis, run by Woolsey Pharmaceuticals at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Through study completion, up to 216 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.