Acute Ischemic StrokePhase 2NCT04091945
A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS
A Phase 2 study testing LT3001 Drug Product in people with Acute Ischemic Stroke, run by Lumosa Therapeutics Co., Ltd. at 10 sites in 2 countries.
Trial summary
This is a multicenter, double-blind, single-dose, randomized, and placebo-controlled prospective Phase IIa clinical study, designed to evaluate LT3001 drug product versus placebo/control in subjects with AIS. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- LT3001 Drug Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 27 Jan 2020to 22 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 90 years
- NIHSS of 4 to 30
- Diagnosis of AIS within 24 hours after stroke symptoms onset
Who cannot join
- Treatement with approved drug during the current AIS
- Pre-stroke disability
- Imaging evidence of acute intracranial hemorrhage, intraparenchymal tumor, arteriovenous malformations, other central nervous system lesions that could increase bleeding risk, or aneurysm requiring treatment
- Suspected subarachnoid hemorrhage
- Seizure
- Uncontrolled hypertension
Show all 14Show fewer
- INR >1.7 and/or abnormal aPTT or platelet count <100,000/mm3
- Blood glucose concentration <50 mg/dL or >400 mg/dL
- Lactating or pregnant subjects or those planning to become pregnant during the study
- Received anticoagulants and/or antiplatelet therapy and glycoprotein IIb/IIIa inhibitors within 48 hours
- AIS, myocardial infarction, serious head trauma or major surgery within 90 days
- Bleeding event within 21 days
- Puncture of noncompressible vessels within 7 days
- Severe hepatic, renal, and/or infectious disease
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Taiwan6 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Linkou Chang Gung Memorial Hospital
New Taipei City
Taipei Medical University - Shuang Ho Hospital
New Taipei City
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
Taipei Veterans General Hospital
Taipei
United States4 sites
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, 37403
The Ohio State University - Wexner Medical Center
Columbus, Ohio, 43210
JFK Neuroscience Institute, JFK Medical Center
Edison, New Jersey, 08837
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
About this study
Official title: A Phase IIa, Double-Blind, Single Dose, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Potential Efficacy of LT3001 Drug Product in Subjects With Acute Ischemic Stroke (AIS)
This is a multicenter, double-blind, single-dose, randomized, and placebo-controlled prospective Phase IIa clinical study, designed to evaluate LT3001 drug product versus placebo/control in subjects with AIS.
- Conditions
- Acute Ischemic Stroke
- Being tested
- LT3001 Drug Product, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LT3001 Drug ProductDrug
Active comparator
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| LT3001 Drug Product | Active comparator | Not described Receives: Drug: LT3001 Drug Product |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Subject Have Symptomatic Intracranial Hemorrhage (sICH) of a Single Dose LT3001 Drug Product in Subjects With AIS.
Compare the the percentage of subject having sICH between LT3001 drug product and Placebo.
Measured: Within 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start27 Jan 2020
- Primary completion22 Feb 2021
- Study completion22 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumosa Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091945
- Sponsor's protocol ID
- LT3001-201
- Status last verified
- Jan 2026
- First submitted
- 5 Sep 2019
- Last updated
- 22 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chao AC, Lee TH, Pettigrew LC, Hannawi Y, Huang HY, Chi NF, Chan L, Chen PL, Devlin T. Intravenous Odatroltide for Acute Ischemic Stroke Within 24 Hours of Onset: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study. Drug Des Devel Ther. 2024 Jun 6;18:2033-2042. doi: 10.2147/DDDT.S460831. eCollection 2024.
PubMed 38859883
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Double-Blind, Single Dose, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Potential Efficacy of LT3001 Drug Product in Subjects With Acute Ischemic Stroke (AIS)
- ClinicalTrials.gov ID
- NCT04091945
- Acronym / sponsor ID
- LT3001-201
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lumosa Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Posted 30 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, double-blind, single-dose, randomized, and placebo-controlled prospective Phase IIa clinical study, designed to evaluate LT3001 drug product versus placebo/control in subjects with AIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LT3001 Drug Product | Active comparator | Drug: LT3001 Drug Product |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 90 years
- NIHSS of 4 to 30
- Diagnosis of AIS within 24 hours after stroke symptoms onset
Key exclusion criteria (14 listed)
- Treatement with approved drug during the current AIS
- Pre-stroke disability
- Imaging evidence of acute intracranial hemorrhage, intraparenchymal tumor, arteriovenous malformations, other central nervous system lesions that could increase bleeding risk, or aneurysm requiring treatment
- Suspected subarachnoid hemorrhage
- Seizure
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 |
|---|---|---|
| LT3001 Drug ProductActive comparator | Drug | LT3001 Drug Product |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
The Percentage of Subject Have Symptomatic Intracranial Hemorrhage (sICH) of a Single Dose LT3001 Drug Product in Subjects With AIS.
Time frame: Within 36 hours
Compare the the percentage of subject having sICH between LT3001 drug product and Placebo.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38859883Chao AC, Lee TH, Pettigrew LC, Hannawi Y, Huang HY, Chi NF, Chan L, Chen PL, Devlin T. Intravenous Odatroltide for Acute Ischemic Stroke Within 24 Hours of Onset: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study. Drug Des Devel Ther. 2024 Jun 6;18:2033-2042. doi: 10.2147/DDDT.S460831. eCollection 2024.
Related trials for Acute Ischemic Stroke
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingObservational study
Natural History of Stroke: Cause and Development
Brain Disease, Ischemic Attack, Transient
Not yet recruiting
Prehospital Response and Emergency Stroke Transport Optimisation
Acute Ischemic Stroke
RecruitingPhase 2
A Study to Evaluate the Intracranial Arterial Recanalization With Multiple Doses of LT3001 Drug Product in AIS Participant
Acute Ischemic Stroke
Active, not recruiting
Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
10 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 LT3001 Drug Product in people with Acute Ischemic Stroke, run by Lumosa Therapeutics Co., Ltd. at 10 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 3 inclusion and 14 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: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Taiwan, United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 30 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Percentage of Subject Have Symptomatic Intracranial Hemorrhage (sICH) of a Single Dose LT3001 Drug Product in Subjects With AIS. (time frame: Within 36 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04091945, which also lists 1 linked publication.
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 22 Jan 2026.